Introgen Therapeutics Inc., citing "significant progress" on its Advexin cancer therapy, says it will soon begin crunching statistical numbers from its Phase 3 clinical trials of the gene treatment.
Introgen CEO David Nance said in a conference call with investors Thursday that the company reached an agreement with the U.S. Food and Drug Administration over the statistical methodology for the analysis and will begin in early 2007. The analysis will go toward Introgen's eventual licensing of the therapy for head and neck cancers.
Advexin uses a cancer tumor-fighting gene to kill cancer cells unreceptive to other treatments.
Nance also said Introgen will pursue European regulatory approval for therapy in early 2007.
NASDAQ:INGN
To help with the expensive late-stage regulatory approval process here and abroad, the company recently sold 5 million shares of its common stock to raise about $30 million. Nance said the company will add the new cash to its existing stash to create $50 million in reserves to support the regulatory process.
Advexin works by delivering the tumor suppressor protein p53 that targets a fundamental molecular cancer defect and selectively kills cancer cells. Expanded p53 biomarker studies confirmed with high statistical significance the survival benefit of ADVEXIN therapy in patients with abnormal p53 function. The new results demonstrated that patients with the abnormal p53 biomarker in recurrent squamous cell carcinoma of the head and neck were most likely to have a survival benefit from their use of ADVEXIN therapy.
Despite the seemingly good news, the Austin biotech firm's stock was down more than 6 percent Friday to $4.40.
Saturday, December 30, 2006
Friday, December 29, 2006
InterMune expected to move in Friday's trading:
After Thursday's closing bell, InterMune said it has filed a universal shelf registration statement to sell up to $175 million of its shares, preferred stock, debt securities and warrants. The biotech concern said Warburg, Pincus Equity Partners L.P. registered its 7.36 million previously-issued shares, and may be a selling shareholder.
I still am bullish on the phase III data from last week.
ITMN closed thursday's trading up 32 cents/share to $30.72.
I still am bullish on the phase III data from last week.
ITMN closed thursday's trading up 32 cents/share to $30.72.
Thursday, December 28, 2006
Nasdaq to close Tuesday for President Ford's funeral
SAN FRANCISCO (MarketWatch) -- The Nasdaq Stock Market said late Thursday it will close next Tuesday to mark the funeral of President Gerald Ford. President Bush announced earlier that Tuesday will be a national day of mourning. The New York Stock Exchange was expected to make an announcment shortly, the Associated Press reported. Ford died at his Rancho Mirage, Calif., home on Tuesday at age 93. In the past, financial markets have closed for presidential funerals.
Threshold Pharma Stocks Up on Glufofamide trial data
Threshold Pharmaceuticals, Inc. Announces Top-Line Phase 2 Clinical Trial Results Of Glufosfamide For Treatment Of Pancreatic Cancer; Stocks Rise
REDWOOD CITY, Calif., Dec. 27-- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD - News), today announced top-line results from the Phase 2 clinical trial of glufosfamide in combination with gemcitabine for the treatment of advanced pancreatic cancer. 21% of patients in the clinical trial had a partial response (including one unconfirmed partial response) and 36% of patients had stable disease. Glufosfamide was generally well tolerated in combination with gemcitabine with no new unexpected adverse events.
In the Phase 2 clinical trial, 29 patients were treated, of which 28 patients with pancreatic adenocarcinoma previously untreated with chemotherapy were evaluated for response. Overall, 5 patients achieved a confirmed partial response and one other patient achieved an unconfirmed partial response. In addition, 10 patients experienced stable disease. Objective response was assessed radiologically after every two cycles of therapy. A partial response is characterized as a decrease in size by 30% of the sum of the longest diameters of target lesions, the absence of progression of all non-target lesions and no new lesions.
Pancreatic cancer is a death sentence; it is very hard to treat directly and metastasizes very rapidly. These tumors are very aggressive and painful for the patient, so any type of drug that will present a 30% decrease in tumor size is significant.
Glufosfamide targets tumor cells in the pancreas by targeting overexpressed glucose transport receptors. It has been shown that these tumor cells have a greater glucose metabolism rate, thus making the drug selective. Once inside the cell, glufosfamide is converted to an active form, which alkylates DNA resulting in cell death.
THLD closed today's trading up 28% to $4.11 and up another 2 cents per share in after hours trading. THLD stock has a 52 week trading range from 1.42 to 16.98.
Other biotech stocks making news today were Biosante Pharmaceuticals which also rose on clinical news, up 5% at $2.80, after hitting an earlier high of $3.06. Early Thursday, the biotech group announced it had started Phase III clinical testing for LibiGel, a therapy for female sexual dysfunction in women with menopause triggered by surgery.
Shares of Encysive Pharmaceuticals plunged 24% to $4.49 on word that the Food and Drug Administration has now classified its drug candidate Thelin as a Class II drug, which could complicate its approval process, according to analysts. Encysive has been seeking to get Thelin, a treatment of the life-threatening lung disorder pulmonary arterial hypertension, approved in the U.S. since 2005.
REDWOOD CITY, Calif., Dec. 27-- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD - News), today announced top-line results from the Phase 2 clinical trial of glufosfamide in combination with gemcitabine for the treatment of advanced pancreatic cancer. 21% of patients in the clinical trial had a partial response (including one unconfirmed partial response) and 36% of patients had stable disease. Glufosfamide was generally well tolerated in combination with gemcitabine with no new unexpected adverse events.
In the Phase 2 clinical trial, 29 patients were treated, of which 28 patients with pancreatic adenocarcinoma previously untreated with chemotherapy were evaluated for response. Overall, 5 patients achieved a confirmed partial response and one other patient achieved an unconfirmed partial response. In addition, 10 patients experienced stable disease. Objective response was assessed radiologically after every two cycles of therapy. A partial response is characterized as a decrease in size by 30% of the sum of the longest diameters of target lesions, the absence of progression of all non-target lesions and no new lesions.
Pancreatic cancer is a death sentence; it is very hard to treat directly and metastasizes very rapidly. These tumors are very aggressive and painful for the patient, so any type of drug that will present a 30% decrease in tumor size is significant.
Glufosfamide targets tumor cells in the pancreas by targeting overexpressed glucose transport receptors. It has been shown that these tumor cells have a greater glucose metabolism rate, thus making the drug selective. Once inside the cell, glufosfamide is converted to an active form, which alkylates DNA resulting in cell death.
THLD closed today's trading up 28% to $4.11 and up another 2 cents per share in after hours trading. THLD stock has a 52 week trading range from 1.42 to 16.98.
Other biotech stocks making news today were Biosante Pharmaceuticals which also rose on clinical news, up 5% at $2.80, after hitting an earlier high of $3.06. Early Thursday, the biotech group announced it had started Phase III clinical testing for LibiGel, a therapy for female sexual dysfunction in women with menopause triggered by surgery.
Shares of Encysive Pharmaceuticals plunged 24% to $4.49 on word that the Food and Drug Administration has now classified its drug candidate Thelin as a Class II drug, which could complicate its approval process, according to analysts. Encysive has been seeking to get Thelin, a treatment of the life-threatening lung disorder pulmonary arterial hypertension, approved in the U.S. since 2005.
Wednesday, December 27, 2006
Cashing in at the end of the year: Cambrex CEO Sells Shares
Cambrex President, Chairman and CEO Sells 51,108 Shares
NEW YORK (AP) -- The president, chairman and chief executive of Cambrex Corp., which makes the active ingredients in pharmaceuticals, exercised options for 51,108 shares of common stock, according to a Securities and Exchange Commission filing Wednesday.
In a Form 4 filed with the SEC, James A. Mack exercised 24,200 options on Friday and 26,908 options on Tuesday for $22.06. He sold the same number of shares on Friday and Tuesday for $22.90 apiece.
Insiders file Form 4s with the SEC to report transactions in their companies' shares. Open market purchases and sales must be reported within two business days of the transaction.
Do the math, that's some serious cash!
NEW YORK (AP) -- The president, chairman and chief executive of Cambrex Corp., which makes the active ingredients in pharmaceuticals, exercised options for 51,108 shares of common stock, according to a Securities and Exchange Commission filing Wednesday.
In a Form 4 filed with the SEC, James A. Mack exercised 24,200 options on Friday and 26,908 options on Tuesday for $22.06. He sold the same number of shares on Friday and Tuesday for $22.90 apiece.
Insiders file Form 4s with the SEC to report transactions in their companies' shares. Open market purchases and sales must be reported within two business days of the transaction.
Do the math, that's some serious cash!
Targacept shares jump on continued development of AZD3480 drug
Targacept shares jumped after the company said it's received confirmation from AstraZeneca of plans to continue development of AZD3480 in Alzheimer's disease and cognitive deficits in schizophrenia. This determination triggers a $20 million milestone payment to Targacept.
In afternoon trading, (TRGT 8.95, +1.51, +20.3% ) ; (AZN : 53.75, +0.17, +0.3% ).
In the brain, the hallmark characteristics of AD are amyloid plaques and neurofibrillary tangles. Amyloid plaques are clumps of beta-amyloid, a protein fragment that is produced by abnormal processing of the amyloid precursor protein (APP). Beta-amyloid has also been called amyloid beta or Aβ. A major component of the neurofibrillary tangles is the protein tau. Development of these abnormal structures in the brain eventually results in disruptions in the transmissions between nerve cells (neurons) and death of the neuron.
AZD3480 is a highly selective nicotinic receptor agonist--acetyl choline is it's natural ligand and is a neurotransmitter. Inhibition of Ach degradation then stops the active metabolites from damaging nerve cells.
One half hour before market close, TRGT is trading up 21.5% per share; thats $1.60/share at $9.04!
In afternoon trading, (TRGT 8.95, +1.51, +20.3% ) ; (AZN : 53.75, +0.17, +0.3% ).
In the brain, the hallmark characteristics of AD are amyloid plaques and neurofibrillary tangles. Amyloid plaques are clumps of beta-amyloid, a protein fragment that is produced by abnormal processing of the amyloid precursor protein (APP). Beta-amyloid has also been called amyloid beta or Aβ. A major component of the neurofibrillary tangles is the protein tau. Development of these abnormal structures in the brain eventually results in disruptions in the transmissions between nerve cells (neurons) and death of the neuron.
AZD3480 is a highly selective nicotinic receptor agonist--acetyl choline is it's natural ligand and is a neurotransmitter. Inhibition of Ach degradation then stops the active metabolites from damaging nerve cells.
One half hour before market close, TRGT is trading up 21.5% per share; thats $1.60/share at $9.04!
Tuesday, December 26, 2006
Adventrx to Begin Trials on Cancer Drug
FDA Approves Investigational New Drug Application for Adventrx Cancer Drug
SAN DIEGO (AP) -- Adventrx Pharmaceuticals Inc. said Tuesday the Food and Drug Administration accepted its investigational new drug application for a potential cancer drug.
The drug maker will conduct trials to establish that its drug, ANX-530, works the same as Navelbine, an anti-cancer agent approved to fight non-small cell lung cancer.
A 28-person clinical trial is expected to begin in January.
Adventrx expects to file a new drug application by the end of 2007, potentially making ANX-530 the company's first commercial oncology product.
Shares closed Friday's American Stock Exchange session at $2.64, and rose 11 cents, or 4.2 percent, to $2.75 in pre-market electronic trading. Over the past year, the stock has ranged between $2.26 and $5.38.
ANX is trading up again today at $2.82, up 18 cents per share.
ANX-530 is the same a Navelbine, which are cell cycle inhibitors. Dividing cells have specific stages of replication. ANX-530 stops cell division at the mitosis stage, M phase. It interacts with a protein called tubulin, which is necessary for chromosome separation and microtubule assembly. ANX-530 belongs to the class of drugs termed vinca alkoloids.
SAN DIEGO (AP) -- Adventrx Pharmaceuticals Inc. said Tuesday the Food and Drug Administration accepted its investigational new drug application for a potential cancer drug.
The drug maker will conduct trials to establish that its drug, ANX-530, works the same as Navelbine, an anti-cancer agent approved to fight non-small cell lung cancer.
A 28-person clinical trial is expected to begin in January.
Adventrx expects to file a new drug application by the end of 2007, potentially making ANX-530 the company's first commercial oncology product.
Shares closed Friday's American Stock Exchange session at $2.64, and rose 11 cents, or 4.2 percent, to $2.75 in pre-market electronic trading. Over the past year, the stock has ranged between $2.26 and $5.38.
ANX is trading up again today at $2.82, up 18 cents per share.
ANX-530 is the same a Navelbine, which are cell cycle inhibitors. Dividing cells have specific stages of replication. ANX-530 stops cell division at the mitosis stage, M phase. It interacts with a protein called tubulin, which is necessary for chromosome separation and microtubule assembly. ANX-530 belongs to the class of drugs termed vinca alkoloids.
Friday, December 22, 2006
InterMune soars on positive drug news
Boston- 22 December-- Shares of InterMune shot up 20% to $26.57 on news that Japanese drug developer Shionogi has released positive data from a Phase III clinical trial for the compound pirfenidone in the treatment of idiopathic pulmonary fibrosis, a life-threatening lung disease. InterMune is currently conducting Phase III testing for pirfenidone for treatment of the same illness. InterMune revealed the news in a regulatory filing made Friday.
The lungs are extremely sensitive to inflammatory reactions mediated by TNF-{alpha}, and two life-threatening syndromes, vascular leak and respiratory distress, develop during severe bacterial infection. Without immediate intervention, these conditions are lethal. Suppression of TNF-{alpha} and other proinflammatory cytokines limits acute symptoms, thereby reducing immediate respiratory dysfunction. However, residual damage resulting from inflammatory reactions can thicken alveolar walls and decrease alveolar function through a disease process known as pulmonary fibrosis. Without further treatment, these fibrotic lesions cause permanent and irreparable damage within the lungs.
Pirfenidone acts to reduce pulmonary fibrosis and protect against endotoxic shock.
ITMN closed today's trading at $28.40 per share or gaining $6.39!
The lungs are extremely sensitive to inflammatory reactions mediated by TNF-{alpha}, and two life-threatening syndromes, vascular leak and respiratory distress, develop during severe bacterial infection. Without immediate intervention, these conditions are lethal. Suppression of TNF-{alpha} and other proinflammatory cytokines limits acute symptoms, thereby reducing immediate respiratory dysfunction. However, residual damage resulting from inflammatory reactions can thicken alveolar walls and decrease alveolar function through a disease process known as pulmonary fibrosis. Without further treatment, these fibrotic lesions cause permanent and irreparable damage within the lungs.
Pirfenidone acts to reduce pulmonary fibrosis and protect against endotoxic shock.
ITMN closed today's trading at $28.40 per share or gaining $6.39!
SciClone Pharmaceuticals, Inc. (SCLN) And Sigma-Tau Announce Positive Interim Survival Data From Large Phase 2 Malignant Melanoma Trial; Stock Up 43%
SAN MATEO, CA-Dec 22, 2006- SciClone Pharmaceuticals, Inc. and Sigma-Tau S.p.A. today announced positive interim survival data from a large phase 2 trial treating patients with stage IV malignant melanoma, the most advanced form of this cancer. Data from the first four arms of this ongoing five-arm trial showed that the addition of 3.2 mg of ZADAXIN® (thymalfasin or thymosin alpha 1) to standard dacarbazine (DTIC) chemotherapy increased the median survival to 10.2 months. These data compare favorably to the median survival of 6.6 months for patients treated with DTIC chemotherapy with interferon alpha. DTIC is the only approved therapy in the United States for the treatment of advanced melanoma. In addition, data show patients treated with thymalfasin and DTIC chemotherapy without interferon alpha achieved
more than double the overall tumor response as compared to the control group, consistent with previously reported interim results. SciClone and Sigma-Tau expect to present detailed clinical results from this trial including statistical analyses at the upcoming ASCO meeting.
"Based on the strength of these data, we and Sigma-Tau plan to meet with U.S. and European regulatory authorities to discuss a phase 3 clinical trial design using ZADAXIN and DTIC chemotherapy," commented Friedhelm Blobel, Ph.D., Chief Executive Officer of SciClone Pharmaceuticals, Inc. "We are pleased that the addition of ZADAXIN to the current standard of care may offer survival benefits to patients diagnosed with this life-threatening cancer."
"We are excited to observe the positive effects on survival and overall tumor response when ZADAXIN is added to standard DTIC chemotherapy in treating patients with malignant melanoma," commented Roberto Camerini, M.D., Research and Development for Sigma-Tau S.p.A. "Current therapy for the advanced stages of this cancer provides minimal survival benefit for the patient. We are particularly encouraged of the prospect of improving patient survival with the addition of thymalfasin, a drug shown to be safe and well tolerated in several other clinical settings."
The market impact on these results should be rather large if in the end, if it's approved for all stages of melanoma and other cancers. Melanoma is roughly responsible for nearly 80% of all cancer deaths.
Thymalfasin is the synthetic version of thymosin alpha 1, a substance found naturally in the circulation and produced in the body's thymus gland. Thymosin stimulates the immune system by affecting T cells and NK cells, which are the body's most potent defense against infectious diseases and tumor cells. It is this ability to act as an immunomodulator that makes ZADAXIN a promising therapy for such a wide variety of clinical conditions. Stimulation of the immune system in this way is tricky however, and requires careful dosing regimens that can stimulate the immune system but not over produce the inflammatory response.
NASDAQ:SCLN- in late afternoon trading is up to $3.23 (up 97 cents a share)
more than double the overall tumor response as compared to the control group, consistent with previously reported interim results. SciClone and Sigma-Tau expect to present detailed clinical results from this trial including statistical analyses at the upcoming ASCO meeting.
"Based on the strength of these data, we and Sigma-Tau plan to meet with U.S. and European regulatory authorities to discuss a phase 3 clinical trial design using ZADAXIN and DTIC chemotherapy," commented Friedhelm Blobel, Ph.D., Chief Executive Officer of SciClone Pharmaceuticals, Inc. "We are pleased that the addition of ZADAXIN to the current standard of care may offer survival benefits to patients diagnosed with this life-threatening cancer."
"We are excited to observe the positive effects on survival and overall tumor response when ZADAXIN is added to standard DTIC chemotherapy in treating patients with malignant melanoma," commented Roberto Camerini, M.D., Research and Development for Sigma-Tau S.p.A. "Current therapy for the advanced stages of this cancer provides minimal survival benefit for the patient. We are particularly encouraged of the prospect of improving patient survival with the addition of thymalfasin, a drug shown to be safe and well tolerated in several other clinical settings."
The market impact on these results should be rather large if in the end, if it's approved for all stages of melanoma and other cancers. Melanoma is roughly responsible for nearly 80% of all cancer deaths.
Thymalfasin is the synthetic version of thymosin alpha 1, a substance found naturally in the circulation and produced in the body's thymus gland. Thymosin stimulates the immune system by affecting T cells and NK cells, which are the body's most potent defense against infectious diseases and tumor cells. It is this ability to act as an immunomodulator that makes ZADAXIN a promising therapy for such a wide variety of clinical conditions. Stimulation of the immune system in this way is tricky however, and requires careful dosing regimens that can stimulate the immune system but not over produce the inflammatory response.
NASDAQ:SCLN- in late afternoon trading is up to $3.23 (up 97 cents a share)
Thursday, December 21, 2006
Thursday's Pharma Advancers:
Abiomed Inc. received 510(k) clearance from the Food and Drug Administration for its new intra-aortic balloon, a technology designed to enhance blood flow to the heart and other organs.
Accentia Biopharmaceuticals shares surged after the Tampa, Fla.-based company announced it has entered into mutual confidentiality agreements with several unnamed pharmaceutical companies that have approached the company over SinuNase. Accentia said in a statement it believes that potential relationships could provide "upfront and milestone payments as well as enhance the commercial opportunity for SinuNase." Currently in Phase III trials, SinuNase, a treatment for chronic sinusitis, has been granted fast-track status by the Food and Drug Administration.
Anika Therapeutics Inc. said it obtained FDA approval for its cosmetic tissue augmentation. Anika said the product is an injectable soft-tissue filler for facial wrinkles, scar remediation and lip augmentation.
Bristol-Myers Squibb Co. said would pay $499 million as part of a tentative agreement it made with federal authorities to settle several probes into the drug company's pricing and sales and marketing activities
Accentia Biopharmaceuticals shares surged after the Tampa, Fla.-based company announced it has entered into mutual confidentiality agreements with several unnamed pharmaceutical companies that have approached the company over SinuNase. Accentia said in a statement it believes that potential relationships could provide "upfront and milestone payments as well as enhance the commercial opportunity for SinuNase." Currently in Phase III trials, SinuNase, a treatment for chronic sinusitis, has been granted fast-track status by the Food and Drug Administration.
Anika Therapeutics Inc. said it obtained FDA approval for its cosmetic tissue augmentation. Anika said the product is an injectable soft-tissue filler for facial wrinkles, scar remediation and lip augmentation.
Bristol-Myers Squibb Co. said would pay $499 million as part of a tentative agreement it made with federal authorities to settle several probes into the drug company's pricing and sales and marketing activities
Wednesday, December 20, 2006
Nice Article on Biotechnology Stocks
SAN DIEGO-- The moral of the story of Northfield Laboratories is that no matter how hot a biotech story may be, in the end it's the science that counts.
The biotech company's stock tumbled 20% before Tuesday's close and another 50% in the after markets following its disclosure not only of disappointing preliminary late-stage test results, but that the results included "discrepancies."
Never mind the normal risks associated with biotech: The risk of disappointing results was high at Northfield for the simple reason that since its founding in 1985, it has been working on a blood substitute -- a holy grail of biotech that has left a trail of stock-market blowups in its wake.
That's why Northfield was one of three potentially hazardous biotech companies I mentioned over the weekend in the Wall Street Journal as having unusually high-risk following last week's share-price implosions of Nuvelo and NeoPharm. Both lost much of their market value after releasing disappointing late-state clinical trial results.
While final data for Northfield may be different once the discrepancies are cleared up, investors should once and for all realize there are no guarantees when dealing with drug trials and approvals. "When you are investing in the biotech sector, you have to be careful," says David Miller of Biotech Stock Research, an independent research firm in Seattle. "It should be a portion of a diversified portfolio, and the portion you have in biotech should itself be diversified, because only one out of every 10 biotech companies succeeds."
Caution may sound obvious, but it can't be stressed enough considering that a typical disappointment, Miller says, can lead to an overnight share loss of 40% to 60%.
In the wake of Northfield, Nuvelo and NeoPharm, which companies hold similar risk? It's anybody's guess, of course, but it's not hard to find published warnings on more than a few biotech companies.
Among them: Telik, an 18-year-old Palo Alto, Calif., company that any day is expected to report test data on its Telcyta-branded drugs for ovarian and lung cancers. Like many aging developmental biotech companies, it has dug a deep hole of losses, which as of last quarter totaled around $375 million on virtually no revenue and a market value of about $866 million. While its stock has been declining, Lehman Brothers analyst Jim Birchenough, a physician by training, downgraded it last month to "underweight," saying that based on his read of available data, he believes "significant downside risk exists...." A Telik spokeswoman declined to comment.
Then there's Neurochem , whose shares have leaped more than 40% over the past month -- tripling since August -- largely on anticipation for its Alzhemed Alzheimer's treatment, whose final round of test results are expected this spring. Founded in 1986, the Quebec-based company has nearly $200 million in accumulated losses, little in the way of revenue and a market value of $961 million. Noting the stock's recent rise, Toronto-based RBC Dominion Securities analyst Philippa Flint, who rates the stock an "underperform," told clients that "investors are assuming minimal risk of clinical development," when instead "we believe the risk is excessive and recommend investors take profits." Toronto-based Sprott Securities analyst David Dean went a step further, saying that "the trials are likely to fail."
Neurochem Chief Executive Officer Francesco Bellini acknowledges that the trials are "difficult" and that they "may fail." But he also says the patients in the current trial appear to be "doing well" and he wouldn't be an investor in the company if he didn't believe in the drug.
But even Mr. Bellini says investors in biotech should diversify. And what if the skeptics are wrong? "You have to always keep in mind, no matter how sexy the drug, no matter how bad you want prostate cancer cured -- in the end, you're not making a charitable donation," Mr. Miller reminds investors. "It's your investment capital, and you have to protect yourself by spreading it around." Just ask anybody who, sadly, bet it all on Northfield.
Source: Marketwatch.com
The biotech company's stock tumbled 20% before Tuesday's close and another 50% in the after markets following its disclosure not only of disappointing preliminary late-stage test results, but that the results included "discrepancies."
Never mind the normal risks associated with biotech: The risk of disappointing results was high at Northfield for the simple reason that since its founding in 1985, it has been working on a blood substitute -- a holy grail of biotech that has left a trail of stock-market blowups in its wake.
That's why Northfield was one of three potentially hazardous biotech companies I mentioned over the weekend in the Wall Street Journal as having unusually high-risk following last week's share-price implosions of Nuvelo and NeoPharm. Both lost much of their market value after releasing disappointing late-state clinical trial results.
While final data for Northfield may be different once the discrepancies are cleared up, investors should once and for all realize there are no guarantees when dealing with drug trials and approvals. "When you are investing in the biotech sector, you have to be careful," says David Miller of Biotech Stock Research, an independent research firm in Seattle. "It should be a portion of a diversified portfolio, and the portion you have in biotech should itself be diversified, because only one out of every 10 biotech companies succeeds."
Caution may sound obvious, but it can't be stressed enough considering that a typical disappointment, Miller says, can lead to an overnight share loss of 40% to 60%.
In the wake of Northfield, Nuvelo and NeoPharm, which companies hold similar risk? It's anybody's guess, of course, but it's not hard to find published warnings on more than a few biotech companies.
Among them: Telik, an 18-year-old Palo Alto, Calif., company that any day is expected to report test data on its Telcyta-branded drugs for ovarian and lung cancers. Like many aging developmental biotech companies, it has dug a deep hole of losses, which as of last quarter totaled around $375 million on virtually no revenue and a market value of about $866 million. While its stock has been declining, Lehman Brothers analyst Jim Birchenough, a physician by training, downgraded it last month to "underweight," saying that based on his read of available data, he believes "significant downside risk exists...." A Telik spokeswoman declined to comment.
Then there's Neurochem , whose shares have leaped more than 40% over the past month -- tripling since August -- largely on anticipation for its Alzhemed Alzheimer's treatment, whose final round of test results are expected this spring. Founded in 1986, the Quebec-based company has nearly $200 million in accumulated losses, little in the way of revenue and a market value of $961 million. Noting the stock's recent rise, Toronto-based RBC Dominion Securities analyst Philippa Flint, who rates the stock an "underperform," told clients that "investors are assuming minimal risk of clinical development," when instead "we believe the risk is excessive and recommend investors take profits." Toronto-based Sprott Securities analyst David Dean went a step further, saying that "the trials are likely to fail."
Neurochem Chief Executive Officer Francesco Bellini acknowledges that the trials are "difficult" and that they "may fail." But he also says the patients in the current trial appear to be "doing well" and he wouldn't be an investor in the company if he didn't believe in the drug.
But even Mr. Bellini says investors in biotech should diversify. And what if the skeptics are wrong? "You have to always keep in mind, no matter how sexy the drug, no matter how bad you want prostate cancer cured -- in the end, you're not making a charitable donation," Mr. Miller reminds investors. "It's your investment capital, and you have to protect yourself by spreading it around." Just ask anybody who, sadly, bet it all on Northfield.
Source: Marketwatch.com
Genta cuts more than a third of its workforce
Biopharmaceutical company Genta Inc. said it cut more than a third of its workforce to focus on its oncology development operations and conserve cash.
In a statement, Genta said the reduction of its workforce by 34 people would result in severence expenses of about $700,000.
GNTA.O closed Wednesday's trading at 48 cents a share. Moreover, GNTA has failed to meet NASDAQ Global Market continued listing requirement(s).
The Company’s lead drug from its RNA/DNA Medicines program is Genasense® (oblimersen sodium). Genasense is currently in late-stage clinical trials for the treatment of melanoma, multiple myeloma, chronic lymphocytic leukemia, non-small cell lung cancer, small cell lung cancer and prostate cancer.
In myeloma cells and other tumor cells, resistance to anticancer therapy is associated with the presence of a protein called Bcl-2. Genasense is a drug that turns off the production of the Bcl-2 protein, which may increase a tumor cell's sensitivity to therapy and ultimately, cause cell death.
I posted some information on anti-sense technology a couple of months ago, but briefly here is a refresher.
Antisense is a technology that stops gene expression by using oligoneucleotides (altered DNA or RNA) that closely resemble the gene that is targeted. The oligo binds the gene and inhibits it's expression, hopefully then tumor cells will be vulnerable to treatment.
In a statement, Genta said the reduction of its workforce by 34 people would result in severence expenses of about $700,000.
GNTA.O closed Wednesday's trading at 48 cents a share. Moreover, GNTA has failed to meet NASDAQ Global Market continued listing requirement(s).
The Company’s lead drug from its RNA/DNA Medicines program is Genasense® (oblimersen sodium). Genasense is currently in late-stage clinical trials for the treatment of melanoma, multiple myeloma, chronic lymphocytic leukemia, non-small cell lung cancer, small cell lung cancer and prostate cancer.
In myeloma cells and other tumor cells, resistance to anticancer therapy is associated with the presence of a protein called Bcl-2. Genasense is a drug that turns off the production of the Bcl-2 protein, which may increase a tumor cell's sensitivity to therapy and ultimately, cause cell death.
I posted some information on anti-sense technology a couple of months ago, but briefly here is a refresher.
Antisense is a technology that stops gene expression by using oligoneucleotides (altered DNA or RNA) that closely resemble the gene that is targeted. The oligo binds the gene and inhibits it's expression, hopefully then tumor cells will be vulnerable to treatment.
Altus signs development deal with Genentech
Altus Pharmaceuticals Inc. will make at least $15 million in a new development deal signed with biotechnology giant Genentech Inc. to create treatments for human growth hormone deficiency.
Cambridge, Mass.-based Altus announced on Wednesday that it would work with Calfornia-based Genentech (NYSE: DNA) to develop, manufacture and commercialize ALTU-238, Altus' once-per week formulation of human growth hormone.
The alliance focuses on a collaboration and licensing deal in North America, and Genentech will pay Altus $15 million up front; The company gets another $15 million through a Genentech investment in Altus stock. Altus can make up to $140 million more if the collaboration produces milestones in development and commercialization.
More money could come down the pipeline long-term because Genentech also gets a global commercialization option for ALTU-238. If the option is exercised, Altus is eligible to receive more than $110 million of upfront and milestone payments.
The companies envision co-promoting and marketing ALTU-238 in North America, and Genentech will handle development and commercialization costs for the drug.
Altus estimates the global market for recombinant human growth hormone surpassed $2.5 billion in 2005.
The drug recently completed a Phase II clinical trial that produced promising results. A treatment must successfully finish Phase III testing before it is submitted to federal regulators for approval.
ALTU-238 is a crystallized formulation of hGH that is designed to be administered once weekly through a fine gauge needle for the treatment of hGH disorders in both pediatric and adult populations. Pediatric growth hormone deficiency affects approximately 1 in 3,500 children and 1 in 10,000 adults. The market for hGH was approximately $2.2 billion in 2004. Secondary indications may include small for gestational age, idiopathic short stature, Turner Syndrome, HIV-AIDS, Prader-Willi Syndrome, and short bowel syndrome.
Nasdaq: ALTU in afternoon trading is up 67 cents to $19.65.
Cambridge, Mass.-based Altus announced on Wednesday that it would work with Calfornia-based Genentech (NYSE: DNA) to develop, manufacture and commercialize ALTU-238, Altus' once-per week formulation of human growth hormone.
The alliance focuses on a collaboration and licensing deal in North America, and Genentech will pay Altus $15 million up front; The company gets another $15 million through a Genentech investment in Altus stock. Altus can make up to $140 million more if the collaboration produces milestones in development and commercialization.
More money could come down the pipeline long-term because Genentech also gets a global commercialization option for ALTU-238. If the option is exercised, Altus is eligible to receive more than $110 million of upfront and milestone payments.
The companies envision co-promoting and marketing ALTU-238 in North America, and Genentech will handle development and commercialization costs for the drug.
Altus estimates the global market for recombinant human growth hormone surpassed $2.5 billion in 2005.
The drug recently completed a Phase II clinical trial that produced promising results. A treatment must successfully finish Phase III testing before it is submitted to federal regulators for approval.
ALTU-238 is a crystallized formulation of hGH that is designed to be administered once weekly through a fine gauge needle for the treatment of hGH disorders in both pediatric and adult populations. Pediatric growth hormone deficiency affects approximately 1 in 3,500 children and 1 in 10,000 adults. The market for hGH was approximately $2.2 billion in 2004. Secondary indications may include small for gestational age, idiopathic short stature, Turner Syndrome, HIV-AIDS, Prader-Willi Syndrome, and short bowel syndrome.
Nasdaq: ALTU in afternoon trading is up 67 cents to $19.65.
Tuesday, December 19, 2006
GenVec Surges on Trial Results
Drug developer GenVec's (GNVC) shares gained more than 30% after the company announced positive early results from a trial on its proposed pancreatic cancer drug.
Based on results from the first 51 patients studied, overall survival rates increased 42.5% when GenVec's drug TNFerade was added to a standard treatment for the disease. At one year, the survival rate was 70.5% in the group receiving the drug vs. 28% in the group receiving standard care alone.
The analysis was conducted as an initial component of a planned interim review of trial data by an independent data safety monitoring board, the company says.
"While the interim data is early, we are encouraged by the positive statistical trend," said Dr. Mark Thornton, GenVec's senior vice president of product development.
Shares gained 60 cents to $2.46 Tuesday morning.
TNF alpha is a type I cytokine that is secreted by macrophages and lymphocytes that supports the activation of cytotoxic T cells. These cells (with other granulocytes)then mount an attack on the tumor cells themselves, in order to kill it. Target cancer cells have receptors to TNF, such that when it binds to the receptor, it triggers apoptosis (cell suicide) of cancer cells.
By introcucing this directly into tumor cells and tumors, it remarkable. I can imagine that this will be a boon to early tumor treatment to shrink it then following up with standard methods to finish it off. I say this because it's long been hard to get human genes to stably express in humans. We can get transient expression with viral vectors, but stable expression is difficult because you need a ecotropic virus.
Based on results from the first 51 patients studied, overall survival rates increased 42.5% when GenVec's drug TNFerade was added to a standard treatment for the disease. At one year, the survival rate was 70.5% in the group receiving the drug vs. 28% in the group receiving standard care alone.
The analysis was conducted as an initial component of a planned interim review of trial data by an independent data safety monitoring board, the company says.
"While the interim data is early, we are encouraged by the positive statistical trend," said Dr. Mark Thornton, GenVec's senior vice president of product development.
Shares gained 60 cents to $2.46 Tuesday morning.
TNF alpha is a type I cytokine that is secreted by macrophages and lymphocytes that supports the activation of cytotoxic T cells. These cells (with other granulocytes)then mount an attack on the tumor cells themselves, in order to kill it. Target cancer cells have receptors to TNF, such that when it binds to the receptor, it triggers apoptosis (cell suicide) of cancer cells.
By introcucing this directly into tumor cells and tumors, it remarkable. I can imagine that this will be a boon to early tumor treatment to shrink it then following up with standard methods to finish it off. I say this because it's long been hard to get human genes to stably express in humans. We can get transient expression with viral vectors, but stable expression is difficult because you need a ecotropic virus.
Monday, December 18, 2006
ZLB to pay $120M for MedImmune drug
ZLB Behring completed its purchase of CytoGam, which is used to prevent infections in organ transplant patients, and related assets from MedImmune Inc. on Monday.
Under the terms of the deal, ZLB of King of Prussia, Pa., will pay MedImmune of Gaithersburg, Md., $120 million in cash, $70 million of which is subject to achievement of sales milestones.
The related assets that are part of the acquisition include trademarks, manufacturing contracts and government authorizations associated with the product.
CytoGam, an intravenous immunoglobulin made from human plasma, is enriched in antibodies that target cytomegalovirus -- the most common cause of life-threatening infection occurring in solid organ transplants.
ZLB, which specializes in plasma protein biotherapeutics, is a subsidiary of CSL Ltd. of Melbourne, Australia.
(NASDAQ:MEDI trading is basically unchanged today. I can post the CMV viral data and infection if there is interest.
Under the terms of the deal, ZLB of King of Prussia, Pa., will pay MedImmune of Gaithersburg, Md., $120 million in cash, $70 million of which is subject to achievement of sales milestones.
The related assets that are part of the acquisition include trademarks, manufacturing contracts and government authorizations associated with the product.
CytoGam, an intravenous immunoglobulin made from human plasma, is enriched in antibodies that target cytomegalovirus -- the most common cause of life-threatening infection occurring in solid organ transplants.
ZLB, which specializes in plasma protein biotherapeutics, is a subsidiary of CSL Ltd. of Melbourne, Australia.
(NASDAQ:MEDI trading is basically unchanged today. I can post the CMV viral data and infection if there is interest.
Somaxon Pharmaceuticals, Inc.'s SILENOR Demonstrates Positive Results In Long-Term Phase 3 Clinical Trial In Elderly Patients With Insomnia
SAN DIEGO--Somaxon Pharmaceuticals, Inc. today announced positive results from the company's Phase 3 clinical trial evaluating SILENOR(TM) (doxepin HCl) in elderly patients with chronic primary insomnia. SILENOR(TM) demonstrated a statistically significant improvement compared to placebo in the primary endpoint of this trial, Wake After Sleep Onset (WASO) as measured at night one, for both doses studied (1mg: p=0.0053, 3mg: p less than 0.0001). Statistical significance for this endpoint was also achieved at the end of the twelve week treatment period for both doses studied (1mg: p=0.0330, 3mg: p less than 0.0001).
With the conclusion of this clinical trial, Somaxon has completed six well-controlled clinical trials with SILENOR(TM) for the treatment of insomnia, including four Phase 3 clinical trials. In each of these clinical trials, SILENOR(TM) demonstrated statistically significant results in the trial's designated primary endpoint. These endpoints included measures of both sleep maintenance and sleep onset. The company anticipates filing an NDA with the U.S. Food and Drug Administration (FDA) in the third quarter of 2007, assuming that the company's preclinical studies for SILENOR(TM) are successful and proceed as currently scheduled.
This Phase 3 clinical trial was a randomized, double-blind, placebo-controlled, multi-center, parallel group trial designed to assess the efficacy and safety of 1mg and 3mg of SILENOR(TM) in elderly patients with chronic primary insomnia. The trial enrolled 240 elderly subjects, and efficacy assessments evaluated both objective polysomnography (PSG) and subjective measures of sleep. Subjective efficacy assessments were made both in the sleep laboratory and on an outpatient basis. Safety and efficacy were evaluated over a twelve week period, which we believe represents the longest clinical trial reported to date for insomnia that evaluated efficacy in both the sleep laboratory and outpatient settings.
Silenor is doxepin, a common drug used for treating depression and anxiety disorders. It has heavy sedative effects at concentrations used for depression ( 75-300mg). This is a very low dose 1-3mg, just to reap the sedative effects. It is known as a tricyclic, based on it's 3 ring nucleus structure. Its pharmacological effects include serotonin uptake inhibition, weight gain and sexual dysfunction.
NASDAQ:SOMX is trading up 50 cents in afternoon trading.
With the conclusion of this clinical trial, Somaxon has completed six well-controlled clinical trials with SILENOR(TM) for the treatment of insomnia, including four Phase 3 clinical trials. In each of these clinical trials, SILENOR(TM) demonstrated statistically significant results in the trial's designated primary endpoint. These endpoints included measures of both sleep maintenance and sleep onset. The company anticipates filing an NDA with the U.S. Food and Drug Administration (FDA) in the third quarter of 2007, assuming that the company's preclinical studies for SILENOR(TM) are successful and proceed as currently scheduled.
This Phase 3 clinical trial was a randomized, double-blind, placebo-controlled, multi-center, parallel group trial designed to assess the efficacy and safety of 1mg and 3mg of SILENOR(TM) in elderly patients with chronic primary insomnia. The trial enrolled 240 elderly subjects, and efficacy assessments evaluated both objective polysomnography (PSG) and subjective measures of sleep. Subjective efficacy assessments were made both in the sleep laboratory and on an outpatient basis. Safety and efficacy were evaluated over a twelve week period, which we believe represents the longest clinical trial reported to date for insomnia that evaluated efficacy in both the sleep laboratory and outpatient settings.
Silenor is doxepin, a common drug used for treating depression and anxiety disorders. It has heavy sedative effects at concentrations used for depression ( 75-300mg). This is a very low dose 1-3mg, just to reap the sedative effects. It is known as a tricyclic, based on it's 3 ring nucleus structure. Its pharmacological effects include serotonin uptake inhibition, weight gain and sexual dysfunction.
NASDAQ:SOMX is trading up 50 cents in afternoon trading.
Sunday, December 17, 2006
Posting
Since My company is wrapping things up now until the middle of January, I will have a lot more time to review and post the clinical data.
The markets should be seeing a lot of action this week, so I will be on top of it!
Happy Holidays.
The markets should be seeing a lot of action this week, so I will be on top of it!
Happy Holidays.
Biopure Pressured by FDA Panel Vote
Biopure Shares Fall After FDA Panel Recommends Against Proposed Clinical Trial
CAMBRIDGE, Mass.-- Shares of Biopure Corp. fell sharply Friday after a Food and Drug Administration advisory panel said the Navy's proposed clinical trial of the company's blood substitute would be too risky, and recommended the study not take place.
Biopure shares fell 26 cents, or 44 percent, to 33 cents in morning trading on the Nasdaq. Shares have traded under $1 since late July, causing the company to become non-compliant with Nasdaq listing requirements.
The FDA panel voted 11 to 8 with one abstention to not recommend the Navy's proposed mid- to late-stage clinical trial for Biopure's Hemopure, an emergency treatment made from cow's blood that delivers oxygen to the body when it has lost too much blood.
The panel questioned whether current data on Hemopure allows a Phase III clinical trial under a federal regulation that waives a patient's consent to participate. The product is meant to be used in emergency situations when fresh blood is not readily available, and often, those who would benefit from such a product are not conscious.
I have been following the research and the companies that are working on blood substitues for some time now and even applied for a job at one such company in CO in the early 90's. There are always issues with immune reactions or the product being unstable. I really dont see a profitable market here anytime soon in my scientific opinion.
CAMBRIDGE, Mass.-- Shares of Biopure Corp. fell sharply Friday after a Food and Drug Administration advisory panel said the Navy's proposed clinical trial of the company's blood substitute would be too risky, and recommended the study not take place.
Biopure shares fell 26 cents, or 44 percent, to 33 cents in morning trading on the Nasdaq. Shares have traded under $1 since late July, causing the company to become non-compliant with Nasdaq listing requirements.
The FDA panel voted 11 to 8 with one abstention to not recommend the Navy's proposed mid- to late-stage clinical trial for Biopure's Hemopure, an emergency treatment made from cow's blood that delivers oxygen to the body when it has lost too much blood.
The panel questioned whether current data on Hemopure allows a Phase III clinical trial under a federal regulation that waives a patient's consent to participate. The product is meant to be used in emergency situations when fresh blood is not readily available, and often, those who would benefit from such a product are not conscious.
I have been following the research and the companies that are working on blood substitues for some time now and even applied for a job at one such company in CO in the early 90's. There are always issues with immune reactions or the product being unstable. I really dont see a profitable market here anytime soon in my scientific opinion.
Thursday, December 14, 2006
Alexza completes trial--Stock Skyrockets
BANGALORE, Dec 14 - Shares of Alexza Pharmaceuticals Inc. (ALXA.O: Quote, Profile , Research) rose 25 percent on Thursday, a day after the company said it completed enrollment in a mid-stage trial of its treatment for migraine headaches.
On Wednesday, the company said it was "on track" to provide initial results from the AZ-001 clinical trial by the end of March 2007.
"... this is a relatively under-appreciated small-cap company with four drugs in the clinic and they've got Phase IIb data for their lead migraine drug coming out in the first quarter ... What you are seeing is investors waking up to the story," RBC Capital Markets analyst Jason Kantor told Reuters over the telephone.
Kantor, who was bullish on the stock, said people were realizing that this was a near-term clinical event that had a high probability of success.
"I think that's why the stock is up as much as it is," he noted.
Kantor said the company presented at the brokerage's conference on Wednesday. The brokerage highlighted the stock as its top pick for 2007 on CNBC Thursday morning.
"Good data is being rewarded in the marketplace," Kantor said.
I will update the data from the trial later today. I have to do more research for now.
On Wednesday, the company said it was "on track" to provide initial results from the AZ-001 clinical trial by the end of March 2007.
"... this is a relatively under-appreciated small-cap company with four drugs in the clinic and they've got Phase IIb data for their lead migraine drug coming out in the first quarter ... What you are seeing is investors waking up to the story," RBC Capital Markets analyst Jason Kantor told Reuters over the telephone.
Kantor, who was bullish on the stock, said people were realizing that this was a near-term clinical event that had a high probability of success.
"I think that's why the stock is up as much as it is," he noted.
Kantor said the company presented at the brokerage's conference on Wednesday. The brokerage highlighted the stock as its top pick for 2007 on CNBC Thursday morning.
"Good data is being rewarded in the marketplace," Kantor said.
I will update the data from the trial later today. I have to do more research for now.
Yesterday's Huge Mover: Progen Industries
Shares of drug developer Progen Industries (PGLA) jumped more than 160% after the company announced positive results on an experimental cancer drug.
In clinical trials, patients who had cancerous tumors removed from their livers went 76% longer before tumor recurrence when given the drug, dubbed PI-88, compared with patients not on the treatment. Shares were up $4.75 to $7.70.
I will expound on the drug PI-88 later today. Very interesting mechanism of action.
PGLA is coming back to earth today, closing at 5.20, down almost 20%. More later today.
In clinical trials, patients who had cancerous tumors removed from their livers went 76% longer before tumor recurrence when given the drug, dubbed PI-88, compared with patients not on the treatment. Shares were up $4.75 to $7.70.
I will expound on the drug PI-88 later today. Very interesting mechanism of action.
PGLA is coming back to earth today, closing at 5.20, down almost 20%. More later today.
Charles River Laboratories Shares Jump on 2006, 2007 Guidance
NEW YORK-- Shares of Charles River Laboratories International Inc., maker of research products for drug developers, jumped Thursday after the company backed its 2006 financial forecast and issued guidance for 2007.
The stock gained $2.34, or 5.6 percent, to reach $44.23 on the New York Stock Exchange in afternoon trading. Shares have traded between $33.73 and $51.50 over the last 52 weeks.
Excluding special charges, the company expects profit between $2.15 and $2.21 per share. Analysts polled by Thomson Financial expect profit of $2.17 per share. The company sees sales rising between 6 percent and 8 percent from last year, hitting a range of $1.19 billion to $1.21 billion.
A large part of the boost came from the company's 2007 guidance between $2.43 and $2.53 per share, excluding a 32-cent charge, marking a 15 percent increase. Analysts expect profit of $2.47 per share.
"After two consecutive quarters of beating street estimates, the strength of tonight's guidance marks another data point that the company is better performing today than it was a year ago," wrote Lehman Brothers analyst Douglas D. Tsao, in a note to investors late Wednesday.
The guidance implies a smooth transition into the company's new preclinical development facilities, he wrote, reaffirming a "Overweight" rating with a $48 price target.
Goldman Sachs analyst Alejandro Alvarez said the guidance was largely in line with his expectations, in an investor note. He maintained a "Neutral" rating on the stock.
Jefferies & Company analyst David Windley reaffirmed a "Hold" rating with a $42 price target, citing projected revenue growth in the company's preclinical division.
Most all strains of gentically engineered rodents originated from CRL. Cancer research would not be where it is today without CRL.
CRL is currently trading up 2.15 cents at 44.04 in afternoon trading.
The stock gained $2.34, or 5.6 percent, to reach $44.23 on the New York Stock Exchange in afternoon trading. Shares have traded between $33.73 and $51.50 over the last 52 weeks.
Excluding special charges, the company expects profit between $2.15 and $2.21 per share. Analysts polled by Thomson Financial expect profit of $2.17 per share. The company sees sales rising between 6 percent and 8 percent from last year, hitting a range of $1.19 billion to $1.21 billion.
A large part of the boost came from the company's 2007 guidance between $2.43 and $2.53 per share, excluding a 32-cent charge, marking a 15 percent increase. Analysts expect profit of $2.47 per share.
"After two consecutive quarters of beating street estimates, the strength of tonight's guidance marks another data point that the company is better performing today than it was a year ago," wrote Lehman Brothers analyst Douglas D. Tsao, in a note to investors late Wednesday.
The guidance implies a smooth transition into the company's new preclinical development facilities, he wrote, reaffirming a "Overweight" rating with a $48 price target.
Goldman Sachs analyst Alejandro Alvarez said the guidance was largely in line with his expectations, in an investor note. He maintained a "Neutral" rating on the stock.
Jefferies & Company analyst David Windley reaffirmed a "Hold" rating with a $42 price target, citing projected revenue growth in the company's preclinical division.
Most all strains of gentically engineered rodents originated from CRL. Cancer research would not be where it is today without CRL.
CRL is currently trading up 2.15 cents at 44.04 in afternoon trading.
Wednesday, December 13, 2006
Breaking News: Merck wins latest lawsuit
NEW ORLEANS, Dec 13 A New Orleans jury handed Merck & Co. a victory Wednesday in the latest federal Vioxx product liability trial, finding that the drugmaker adequately warned of the heart risks associated with the medicine.
Merck was sued by 51-year-old Anthony Dedrick, who blamed Vioxx for his 2003 heart attack.
Merck is facing more than 27,000 lawsuits from people who claim to have been harmed by the arthritis drug that was withdrawn from the market in September of 2004 after a study showed that it doubled the risk of heart attack and stroke in patients taking it for at least 18 months.
(MRK) is down 23 cents per share in afterhours trading.
Merck was sued by 51-year-old Anthony Dedrick, who blamed Vioxx for his 2003 heart attack.
Merck is facing more than 27,000 lawsuits from people who claim to have been harmed by the arthritis drug that was withdrawn from the market in September of 2004 after a study showed that it doubled the risk of heart attack and stroke in patients taking it for at least 18 months.
(MRK) is down 23 cents per share in afterhours trading.
Tuesday, December 12, 2006
Roche (RHHBY) Release: Xeloda(R) Combination Meets Primary Endpoint In International Phase III Advanced Colorectal Cancer Study
NUTLEY, N.J.-- Roche announced today that a large, international Phase III study (NO16967) of 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival. Study results showed that the chemotherapy combination XELOX (oral Xeloda plus oxaliplatin) is as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin).
"Our data complement the findings of the NO16966 study, suggesting that XELOX is a very reasonable treatment option for patients with recurrent colorectal cancer," said Mace Rothenberg, MD, lead investigator and Professor of Medicine at Vanderbilt University Medical Center and Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center. "By demonstrating that Xeloda in combination with oxaliplatin was as effective as FOLFOX-4, these two studies provide the strongest evidence yet that Xeloda may be used in place of IV 5-FU in the treatment of patients with advanced colorectal cancer."
Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimates that in 2006, more than 148,000 people in the U.S. will be diagnosed and about 55,000 people will die from the disease.
5 fluoro-uracil is specific for thymidine phosphorylase and inhibits it. TP is upregulated in tumor cells which makes 5FU an attractive drug given it's specificity. TP is associated/upregulated with tumor angiogenesis ( new blood vessels ). I think that the market impact of this rather nice since it's a prodrug, meaning that it is inactive until converted to the active form in the body, thus improving the specificity and pinpoint drug concentrations at tumor sites.
RHHBY ended trading today at 89.15 per share.
"Our data complement the findings of the NO16966 study, suggesting that XELOX is a very reasonable treatment option for patients with recurrent colorectal cancer," said Mace Rothenberg, MD, lead investigator and Professor of Medicine at Vanderbilt University Medical Center and Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center. "By demonstrating that Xeloda in combination with oxaliplatin was as effective as FOLFOX-4, these two studies provide the strongest evidence yet that Xeloda may be used in place of IV 5-FU in the treatment of patients with advanced colorectal cancer."
Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimates that in 2006, more than 148,000 people in the U.S. will be diagnosed and about 55,000 people will die from the disease.
5 fluoro-uracil is specific for thymidine phosphorylase and inhibits it. TP is upregulated in tumor cells which makes 5FU an attractive drug given it's specificity. TP is associated/upregulated with tumor angiogenesis ( new blood vessels ). I think that the market impact of this rather nice since it's a prodrug, meaning that it is inactive until converted to the active form in the body, thus improving the specificity and pinpoint drug concentrations at tumor sites.
RHHBY ended trading today at 89.15 per share.
Monday, December 11, 2006
BioCryst reports encouraging test results on anti-cancer drug
Citing "robust" activity, officials with BioCryst Pharmaceuticals Inc. released today interim results from three clinical studies evaluating the company's leading anti-cancer compound, Fodosine.
The trademarked compound is being developed for the treatment of certain types of leukemias and lymphomas. Data will be presented formally during the 2006 American Society of Hematology Annual Meeting in Orlando, Fla., on Sunday.
Birmingham-based BioCryst develops drugs that block key enzymes involved in cancer, cardiovascular and autoimmune diseases, and viral infections.
Midstudy results of a Phase I/II trial involving the oral formulation of the drug evaluated 34 patients with refractory cutaneous T-cell lymphoma. The overall response rate for these patients was 50 percent, including three patients, or 8.8 percent, with complete responses and 14 patients, or 41 percent, with partial responses.
The study concluded that in addition to a good safety profile, Fodosine demonstrated clinical activity as a single oral agent in patients with advanced stages of the lymphoma. BioCryst plans to initiate a Phase II study.
Charles Bugg, BioCryst's chairman and CEO, said the "encouraging" results "validate the potential importance of Fodosine as a single agent therapy for the treatment of patients with certain types of leukemias and lymphomas."
"We believe that with its robust clinical activity and positive safety profile, Fodosine may be an important addition to the range of treatments available to hematologists and oncologists," Bugg said in a news release announcing the results.
Data presented from a Phase II study of Fodosine in the treatment of patients with clinically active relapsed/refractory T-cell leukemia exhibited promise as well.
Of the 50 patients involved in that trial, nine, or 18 percent, exhibited a complete response. More promising, however, was the restoration of normal blood cell development observed during treatment, indicating the drug's potential for use as a targeted, less toxic therapy to treat the condition.
In turn, Bugg said the company plans to initiate a "pivotal" Phase IIb study.
The third study presented data indicating Fodosine is a safe, well-tolerated drug with preliminary evidence of activity as a single agent in patients with relapsed or refractory B-lineage acute lymphoblastic leukemia.
Said Bugg: "We believe Fodosine has the potential to play a valuable role in the treatment of patients with T-cell and B-cell mediated diseases and we look forward to the continued clinical study of Fodosine."
What's big here is that the drug is oral. That is a HUGE advantage over other chemotherapy drugs. Also, it specifically targets T cell enzymes---less side effects and it appears to be reversible.
Fodosine works by a rather novel mechanism of action. It is a purine nucleoside phosphorylase (PNP)inhibitor and altered levels of the enzyme causes T-cell immunodeficiency. The enzyme is therefore a target for autoimmunity disorders, tissue transplant rejection and T-cell malignancies (cancers).
Again, this will have a very large impact on the market and the company if the oral formulation proves efficacious against T cell lymphoma.
NASDAQ: BCRX: The data must not have impressed investors as much as I'm impressed. BCRX is trading down 14 cents today.
The trademarked compound is being developed for the treatment of certain types of leukemias and lymphomas. Data will be presented formally during the 2006 American Society of Hematology Annual Meeting in Orlando, Fla., on Sunday.
Birmingham-based BioCryst develops drugs that block key enzymes involved in cancer, cardiovascular and autoimmune diseases, and viral infections.
Midstudy results of a Phase I/II trial involving the oral formulation of the drug evaluated 34 patients with refractory cutaneous T-cell lymphoma. The overall response rate for these patients was 50 percent, including three patients, or 8.8 percent, with complete responses and 14 patients, or 41 percent, with partial responses.
The study concluded that in addition to a good safety profile, Fodosine demonstrated clinical activity as a single oral agent in patients with advanced stages of the lymphoma. BioCryst plans to initiate a Phase II study.
Charles Bugg, BioCryst's chairman and CEO, said the "encouraging" results "validate the potential importance of Fodosine as a single agent therapy for the treatment of patients with certain types of leukemias and lymphomas."
"We believe that with its robust clinical activity and positive safety profile, Fodosine may be an important addition to the range of treatments available to hematologists and oncologists," Bugg said in a news release announcing the results.
Data presented from a Phase II study of Fodosine in the treatment of patients with clinically active relapsed/refractory T-cell leukemia exhibited promise as well.
Of the 50 patients involved in that trial, nine, or 18 percent, exhibited a complete response. More promising, however, was the restoration of normal blood cell development observed during treatment, indicating the drug's potential for use as a targeted, less toxic therapy to treat the condition.
In turn, Bugg said the company plans to initiate a "pivotal" Phase IIb study.
The third study presented data indicating Fodosine is a safe, well-tolerated drug with preliminary evidence of activity as a single agent in patients with relapsed or refractory B-lineage acute lymphoblastic leukemia.
Said Bugg: "We believe Fodosine has the potential to play a valuable role in the treatment of patients with T-cell and B-cell mediated diseases and we look forward to the continued clinical study of Fodosine."
What's big here is that the drug is oral. That is a HUGE advantage over other chemotherapy drugs. Also, it specifically targets T cell enzymes---less side effects and it appears to be reversible.
Fodosine works by a rather novel mechanism of action. It is a purine nucleoside phosphorylase (PNP)inhibitor and altered levels of the enzyme causes T-cell immunodeficiency. The enzyme is therefore a target for autoimmunity disorders, tissue transplant rejection and T-cell malignancies (cancers).
Again, this will have a very large impact on the market and the company if the oral formulation proves efficacious against T cell lymphoma.
NASDAQ: BCRX: The data must not have impressed investors as much as I'm impressed. BCRX is trading down 14 cents today.
Sunday, December 10, 2006
FDA Approves Millennium Pharmaceuticals, Inc. VELCADE For Injection For Aggressive Form Of Mantle Cell Lymphoma
CAMBRIDGE, Mass.-- Millennium Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval of VELCADE for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. MCL is a relatively uncommon and aggressive form of non-Hodgkin's lymphoma for which there was no standard of care in the relapsed or refractory setting. MCL has a U.S. prevalence of 10,000 patients. VELCADE is currently the market leader in multiple myeloma (MM) for patients who have received one prior therapy. The approval marks the first indication for VELCADE in lymphoma, the most common blood cancer.
"Mantle cell lymphoma is the most challenging lymphoma to treat because it is commonly resistant to chemotherapy in the relapsed setting," said Andre Goy, M.D., Chief of The Division of Lymphoma, The Cancer Center at Hackensack University Medical Center in Hackensack, N.J. "This approval offers new hope for patients with mantle cell lymphoma who have received at least one prior therapy."
"VELCADE is the first drug to receive FDA approval in relapsed mantle cell lymphoma and is based upon the data from our Phase II trial. This represents a new option for patients and a significant milestone for Millennium," said Deborah Dunsire, M.D., President and CEO, Millennium. "In conjunction with our co-development partner, Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), VELCADE is also being investigated in clinical studies in patients with newly diagnosed multiple myeloma and additional types of non-Hodgkin's lymphoma."
The approval is based on data from the PINNACLE trial, the largest study to date in patients with MCL. PINNACLE was a prospective, multi-center, single-arm, open-label study in patients with MCL whose disease progressed following at least one prior therapy. Response rates to VELCADE were determined according to the International Workshop Response Criteria (IWRC) and based on independent radiologic review of CT scans.
What MCL is and how the drug will treat it:
(MCL) is an aggressive type of non-Hodgkin's lymphoma that generally occurs in middle-aged and elderly people and is becoming increasingly recognized. MCL is a disease of B lymphocytes -- cells that make antibodies to help fight infection -- and is typically found in the lymph nodes, spleen, bone marrow, or blood; it is often diagnosed at an advanced stage. Although MCL usually responds to standard chemotherapy, the responses are not long lasting.
Velcade is a potent, specific, and reversible proteasome inhibitor and the first drug of this type to enter clinical trials. Proteasomes are present in all cells and function to help regulate cell growth. In nonclinical studies, normal cells appear to be able to recover from intermittent proteasome inhibition, but many types of cancer cells undergo apoptosis (programmed cell death) when proteasomes are inhibited, even for a short time.
The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins involved in the cell cycle, growth of new blood vessels (angiogenesis), cell adhesion, cytokine production, apoptosis, and other important cellular processes. Many of the processes that rely on proteasome function can contribute to the growth and survival of cancer cells. Velcade is a potent but reversible inhibitor of the proteasome. By disrupting normal cellular processes, proteasome inhibition promotes apoptosis. Non-clinical data has demonstrated that cancer cells are more susceptible to the effects of proteasome inhibition than normal cells. Due to the reversibility of proteasome inhibition with Velcade, normal cells can recover from its effects, whereas cancer cells are more likely to undergo apoptosis.
This is huge for any leukemia patients that are not responding to initial therapies. I will look for the long term survival rate data and post. As for the market impact, MLNM can look to, in my opinion if the drug is successful, dominate. Watching the stock in pretrading hours-there could be an opportunity here early monday.
MLNM closed friday's trading up 16 cents per share at $11.42.
"Mantle cell lymphoma is the most challenging lymphoma to treat because it is commonly resistant to chemotherapy in the relapsed setting," said Andre Goy, M.D., Chief of The Division of Lymphoma, The Cancer Center at Hackensack University Medical Center in Hackensack, N.J. "This approval offers new hope for patients with mantle cell lymphoma who have received at least one prior therapy."
"VELCADE is the first drug to receive FDA approval in relapsed mantle cell lymphoma and is based upon the data from our Phase II trial. This represents a new option for patients and a significant milestone for Millennium," said Deborah Dunsire, M.D., President and CEO, Millennium. "In conjunction with our co-development partner, Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), VELCADE is also being investigated in clinical studies in patients with newly diagnosed multiple myeloma and additional types of non-Hodgkin's lymphoma."
The approval is based on data from the PINNACLE trial, the largest study to date in patients with MCL. PINNACLE was a prospective, multi-center, single-arm, open-label study in patients with MCL whose disease progressed following at least one prior therapy. Response rates to VELCADE were determined according to the International Workshop Response Criteria (IWRC) and based on independent radiologic review of CT scans.
What MCL is and how the drug will treat it:
(MCL) is an aggressive type of non-Hodgkin's lymphoma that generally occurs in middle-aged and elderly people and is becoming increasingly recognized. MCL is a disease of B lymphocytes -- cells that make antibodies to help fight infection -- and is typically found in the lymph nodes, spleen, bone marrow, or blood; it is often diagnosed at an advanced stage. Although MCL usually responds to standard chemotherapy, the responses are not long lasting.
Velcade is a potent, specific, and reversible proteasome inhibitor and the first drug of this type to enter clinical trials. Proteasomes are present in all cells and function to help regulate cell growth. In nonclinical studies, normal cells appear to be able to recover from intermittent proteasome inhibition, but many types of cancer cells undergo apoptosis (programmed cell death) when proteasomes are inhibited, even for a short time.
The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins involved in the cell cycle, growth of new blood vessels (angiogenesis), cell adhesion, cytokine production, apoptosis, and other important cellular processes. Many of the processes that rely on proteasome function can contribute to the growth and survival of cancer cells. Velcade is a potent but reversible inhibitor of the proteasome. By disrupting normal cellular processes, proteasome inhibition promotes apoptosis. Non-clinical data has demonstrated that cancer cells are more susceptible to the effects of proteasome inhibition than normal cells. Due to the reversibility of proteasome inhibition with Velcade, normal cells can recover from its effects, whereas cancer cells are more likely to undergo apoptosis.
This is huge for any leukemia patients that are not responding to initial therapies. I will look for the long term survival rate data and post. As for the market impact, MLNM can look to, in my opinion if the drug is successful, dominate. Watching the stock in pretrading hours-there could be an opportunity here early monday.
MLNM closed friday's trading up 16 cents per share at $11.42.
Friday, December 08, 2006
Genta Shares Fall As Early Results Show Drug Did Not Improve Survival in Leukemia Patients
NEW YORK -- Shares of Genta Inc. dropped after the small biotech drug developer said Friday that preliminary results from a late-stage clinical trial for its Genasense cancer drug failed to meet its primary endpoint.
Genta shares fell about 15 cents, or 18 percent, to about 67 cents on the Nasdaq at above-average volume. Shares have traded between 35 cents and $3.48 over the past 52 weeks, and have been consistently traded under $1 since September after the Food and Drug Administration questioned whether Genasense would offer any substantial improvement over chemotherapy.
The company said that the addition of its cancer drug Genasense to chemotherapy did not significantly improve the survival of older patients with leukemia who has not received treatment before.
Details of the study will be released at an upcoming scientific meeting.
Shares of GNTA closed today's trading at 65 cents per share or down 19%..OUCH!
I will post some specifics about the drug and how it works in a bit.....
Genta shares fell about 15 cents, or 18 percent, to about 67 cents on the Nasdaq at above-average volume. Shares have traded between 35 cents and $3.48 over the past 52 weeks, and have been consistently traded under $1 since September after the Food and Drug Administration questioned whether Genasense would offer any substantial improvement over chemotherapy.
The company said that the addition of its cancer drug Genasense to chemotherapy did not significantly improve the survival of older patients with leukemia who has not received treatment before.
Details of the study will be released at an upcoming scientific meeting.
Shares of GNTA closed today's trading at 65 cents per share or down 19%..OUCH!
I will post some specifics about the drug and how it works in a bit.....
Sangamo Plans 4 Ongoing Trials in 2007
Sangamo BioSciences Plans to Have 4 Ongoing Clinical Trials by the 2nd Half of 2007
RICHMOND, Calif-- Drug developer Sangamo BioSciences Inc. said Thursday it expects to have two mid-stage clinical trials and two early-stage clinical trials under way by the second half of 2007.
Sangamo shares rose 37 cents, or 5 percent, to $7.71 in morning trading on the Nasdaq. Shares have traded between $3.90 and $8.28 over the past 52 weeks.
One of the mid-stage trials, the company's first, has already started, testing the company's SB-509 drug candidate for the treatment of mild to moderate diabetic neuropathy, or nerve damage caused by diabetes.
The second mid-stage trial seeks to study SB-509 to treat patients with "blocked nerve" conduction. Data from an early-stage clinical trial for this use will be presented in 2007 at a medical conference.
Sangamo plans to start an early-stage clinical trial on an HIV treatment in the second half of 2007 on a compound shown to create immune cells that are resistant to HIV. The company is looking to file paperwork with the Food and Drug Administration to begin the trial by June.
The company also disclosed plans to begin an early-stage clinical trial for the treatment of a type of brain cancer by late in the second half of 2007.
In its outlook, Sangamo plans to have about $53 million in cash by the end of 2006, and about $35 million by the end of 2007.
What is it?
Sangamo's technology is based upon the engineering of a naturally occurring class of DNA transcription factors called zinc finger DNA-binding proteins, or ZFPs. The DNA recognition and binding function of ZFPs can be used to target a variety of functional domains to a gene-specific location. The two-component structure of our engineered ZFP TFs is modeled on the structure of naturally occurring transcription factors. They are currently targeting known disease DNAs for ZFP regulation and modifying their function.
SB-509 is being tested in diabetic neuropathy by targeting the vascular endothelial growth factor gene. They are introducing the zfp-transcription factor into the patients which stimulates the gene to turn on. In rat and rabbit models of diabetic neuropathy, VEGF165-A gene transfer conferred a complete reversal of the deficits in nerve conduction velocities (NCVs- a common test to determine nerve damage) characteristic of diabetes. Preliminary results from clinical studies have indicated improvements in the signs and symptoms of sensory neuropathy in diabetic patients after intramuscular injection of a plasmid DNA encoding VEGF165-A
RICHMOND, Calif-- Drug developer Sangamo BioSciences Inc. said Thursday it expects to have two mid-stage clinical trials and two early-stage clinical trials under way by the second half of 2007.
Sangamo shares rose 37 cents, or 5 percent, to $7.71 in morning trading on the Nasdaq. Shares have traded between $3.90 and $8.28 over the past 52 weeks.
One of the mid-stage trials, the company's first, has already started, testing the company's SB-509 drug candidate for the treatment of mild to moderate diabetic neuropathy, or nerve damage caused by diabetes.
The second mid-stage trial seeks to study SB-509 to treat patients with "blocked nerve" conduction. Data from an early-stage clinical trial for this use will be presented in 2007 at a medical conference.
Sangamo plans to start an early-stage clinical trial on an HIV treatment in the second half of 2007 on a compound shown to create immune cells that are resistant to HIV. The company is looking to file paperwork with the Food and Drug Administration to begin the trial by June.
The company also disclosed plans to begin an early-stage clinical trial for the treatment of a type of brain cancer by late in the second half of 2007.
In its outlook, Sangamo plans to have about $53 million in cash by the end of 2006, and about $35 million by the end of 2007.
What is it?
Sangamo's technology is based upon the engineering of a naturally occurring class of DNA transcription factors called zinc finger DNA-binding proteins, or ZFPs. The DNA recognition and binding function of ZFPs can be used to target a variety of functional domains to a gene-specific location. The two-component structure of our engineered ZFP TFs is modeled on the structure of naturally occurring transcription factors. They are currently targeting known disease DNAs for ZFP regulation and modifying their function.
SB-509 is being tested in diabetic neuropathy by targeting the vascular endothelial growth factor gene. They are introducing the zfp-transcription factor into the patients which stimulates the gene to turn on. In rat and rabbit models of diabetic neuropathy, VEGF165-A gene transfer conferred a complete reversal of the deficits in nerve conduction velocities (NCVs- a common test to determine nerve damage) characteristic of diabetes. Preliminary results from clinical studies have indicated improvements in the signs and symptoms of sensory neuropathy in diabetic patients after intramuscular injection of a plasmid DNA encoding VEGF165-A
Thursday, December 07, 2006
Why did a promising heart drug fail?
Doomed drug highlights complications of meddling with cholesterol.
The failure of a high-profile cholesterol drug has thrown a spotlight on the complicated machinery that regulates cholesterol levels. But many researchers remain confident that drugs to boost levels of 'good' cholesterol are still one of the most promising means to combat spiralling heart disease.
Drug company Pfizer announced on 2 December that it was cancelling all clinical trials of torcetrapib, a drug designed to raise heart-protective high-density lipoproteins (HDLs). In a trial of 15000 patients, a safety board found that more people died or suffered cardiovascular problems after taking the drug plus a cholesterol-lowering statin than those in a control group who took the statin alone.
The news came as a kick in the teeth to many cardiologists because earlier tests in animals and people suggested it would lower rates of cardiovascular disease. "There have been no red flags to my knowledge," says John Chapman, a specialist in lipoproteins and atherosclerosis at the National Institute for Health and Medical Research (INSERM) in Paris who has also studied torcetrapib. "This cancellation came as a complete shock."
Torcetrapib is one of the most advanced of a new breed of drugs designed to raise levels of HDLs, which ferry cholesterol out of artery-clogging plaques to the liver for removal from the body. Specifically, torcetrapib blocks a protein called cholesterol ester transfer protein (CETP), which normally transfers the cholesterol from high-density lipoproteins to low density, plaque-promoting ones. Statins, in contrast, mainly work by lowering the 'bad' low-density lipoproteins.
Under pressure
Researchers are now trying to work out why and how the drug backfired, something that will not become clear until the clinical details are released by Pfizer. One hint lies in evidence from earlier trials that it slightly raises blood pressure in some patients. It was thought that this mild problem would be offset by the heart benefits of the drug. But it is possible that it actually proved fatal in some patients who already suffered high blood pressure.
If blood pressure is the explanation, it would actually be good news for drug developers because it suggests that the problems are specific to this compound. Other prototype drugs that are being developed to block CETP work in a slightly different way and might not suffer the same downfall.
But it is also possible that the whole idea of blocking CETP is flawed, says Moti Kashyap, who directs atherosclerosis research at the VA Medical Center in Long Beach, California.
When HDLs excrete cholesterol in the liver, they actually rely on LDLs for part of this process. So inhibiting CETP, which prevents the transfer of cholesterol from HDL to LDL, might actually cause an abnormal and irreversible accumulation of cholesterol in the body. "You're blocking a physiologic mechanism to eliminate cholesterol and effectively constipating the pathway," says Kashyap.
Going up
Most researchers remain confident that elevating high density lipoproteins levels by one means or another is one of the best routes for helping heart disease patients. But HDLs are complex and not entirely understood.
One approved drug, called niacin, is known to both raise HDL and reduce cardiovascular risk but also causes an unpleasant sensation of heat and tingling. Researchers are exploring whether they can bypass this side effect and whether niacin can lower disease risk more than statins alone.
Scientists are also working on several other means to bump up high-density lipoproteins by, for example, introducing synthetic HDLs.
"The only thing we know is dead in the water is torcetrapib, not the whole idea of raising HDL," says Michael Miller, director of preventive cardiology at the University of Maryland Medical Center, Baltimore.
The downward trading trend continues today. Midday PFE shares are $24.79.
From: Nature Journal.
The failure of a high-profile cholesterol drug has thrown a spotlight on the complicated machinery that regulates cholesterol levels. But many researchers remain confident that drugs to boost levels of 'good' cholesterol are still one of the most promising means to combat spiralling heart disease.
Drug company Pfizer announced on 2 December that it was cancelling all clinical trials of torcetrapib, a drug designed to raise heart-protective high-density lipoproteins (HDLs). In a trial of 15000 patients, a safety board found that more people died or suffered cardiovascular problems after taking the drug plus a cholesterol-lowering statin than those in a control group who took the statin alone.
The news came as a kick in the teeth to many cardiologists because earlier tests in animals and people suggested it would lower rates of cardiovascular disease. "There have been no red flags to my knowledge," says John Chapman, a specialist in lipoproteins and atherosclerosis at the National Institute for Health and Medical Research (INSERM) in Paris who has also studied torcetrapib. "This cancellation came as a complete shock."
Torcetrapib is one of the most advanced of a new breed of drugs designed to raise levels of HDLs, which ferry cholesterol out of artery-clogging plaques to the liver for removal from the body. Specifically, torcetrapib blocks a protein called cholesterol ester transfer protein (CETP), which normally transfers the cholesterol from high-density lipoproteins to low density, plaque-promoting ones. Statins, in contrast, mainly work by lowering the 'bad' low-density lipoproteins.
Under pressure
Researchers are now trying to work out why and how the drug backfired, something that will not become clear until the clinical details are released by Pfizer. One hint lies in evidence from earlier trials that it slightly raises blood pressure in some patients. It was thought that this mild problem would be offset by the heart benefits of the drug. But it is possible that it actually proved fatal in some patients who already suffered high blood pressure.
If blood pressure is the explanation, it would actually be good news for drug developers because it suggests that the problems are specific to this compound. Other prototype drugs that are being developed to block CETP work in a slightly different way and might not suffer the same downfall.
But it is also possible that the whole idea of blocking CETP is flawed, says Moti Kashyap, who directs atherosclerosis research at the VA Medical Center in Long Beach, California.
When HDLs excrete cholesterol in the liver, they actually rely on LDLs for part of this process. So inhibiting CETP, which prevents the transfer of cholesterol from HDL to LDL, might actually cause an abnormal and irreversible accumulation of cholesterol in the body. "You're blocking a physiologic mechanism to eliminate cholesterol and effectively constipating the pathway," says Kashyap.
Going up
Most researchers remain confident that elevating high density lipoproteins levels by one means or another is one of the best routes for helping heart disease patients. But HDLs are complex and not entirely understood.
One approved drug, called niacin, is known to both raise HDL and reduce cardiovascular risk but also causes an unpleasant sensation of heat and tingling. Researchers are exploring whether they can bypass this side effect and whether niacin can lower disease risk more than statins alone.
Scientists are also working on several other means to bump up high-density lipoproteins by, for example, introducing synthetic HDLs.
"The only thing we know is dead in the water is torcetrapib, not the whole idea of raising HDL," says Michael Miller, director of preventive cardiology at the University of Maryland Medical Center, Baltimore.
The downward trading trend continues today. Midday PFE shares are $24.79.
From: Nature Journal.
Tuesday, December 05, 2006
Oragenics Seeks Patent for Unique Gene Targets for Tuberculosis
ALACHUA, Fla.-- Oragenics, Inc. (Amex: ONI - News) announced today that it has filed a U.S. patent application covering a collection of 44 genes of Mycobacterium tuberculosis that are specifically induced during active infection of human patients. The identification of these gene targets offers the promise of a new tuberculosis (TB) diagnostic test to meet a critical worldwide need, and could potentially serve as the basis for an effective new vaccine against tuberculosis infection. According to an October 2006 report by BIO Ventures for Global Health, tuberculosis is the world's leading cause of death by an infectious agent. Although TB is generally considered a problem only for developing countries, public health officials estimate that 10 to 15 million Americans are infected with the latent form of the disease. Those people with latent TB who eventually become contagious, and are left untreated, can infect on average up to 15 others each year.
These novel TB gene targets were discovered using the IVIAT proprietary technology, now exclusively owned by Oragenics as a result of the recent acquisition of the iviGene Corporation. IVIAT, or In Vivo Induced Antigen Technology, is a unique, patented discovery platform designed to identify genes of pathogenic bacteria that are specifically expressed during actual human infections. Dr. Robert Zahradnik, Oragenics' president and CEO stated, "The IVIAT technology has proven its ability to identify novel targets for a number of infectious agents, including Vibrio cholerae, Escherichia coli, and Pseudomonas aeruginosa. The resurgence of tuberculosis, especially tied to the emergence of multi-drug resistant strains of the disease, highlights the pressing global need for new diagnostic tests and therapeutic agents."
Initial funding for this TB project was provided through a competitive Small Business Innovative Research (SBIR) grant from the National Institutes of Research. The company expects to continue the development of this potentially crucial technology through the gene target validation phase, preclinical studies and initial clinical trials for a new diagnostic test and for a vaccine against TB. Oragenics' scientists also plan to further utilize its patented IVIAT platform technology to discover unique gene targets for a number of other serious and dangerous human infectious diseases.
Additional funding will be necessary to exploit the opportunity described above and to continue the Company's operations in the future. Oragenics, Inc. announced that the early exercise of stock warrants by a member of the company's Board of Directors has brought $420,000 into the company. When combined with existing cash, this additional funding, reduced by a current monthly burn rate estimated at $150,000, should result in the company having sufficient funding through first quarter 2007.
IVIAT works like a DNA expression library or a RNA microarray. Much like a RNA:DNA array, you simply put tissue culture media/cell extracts over a coated substrate or in this case human sera. IVIAT avoids the use of animal models by using serum from patients who have experienced disease caused by the pathogen of interest. By pooling sera, they can find the widest possible array of antigens produced during different stages of infection. The pooled serum is absorbed with whole cells and cellular extracts prepared from the pathogen grown in vitro. The resulting adsorbed serum contains the subpopulation of antibodies reactive against in vivo induced antigens. This adsorbed serum is used to probe an inducible expression library containing DNA from the pathogen of interest cloned into an appropriate host such as Escherichia coli. Reactive clones contain a DNA fragment from the pathogen that encodes an in vivo antigen. This is quite a development for the field, given that if they can stream line the time it takes into patient treatment times; I can see a revolution in how systemic bacterial infections are fought. Keep an eye on this one; if they can show reproducibility, the market impact is endless.
ONI closed AMEX trading today down 1 cent per share to $1.26.
These novel TB gene targets were discovered using the IVIAT proprietary technology, now exclusively owned by Oragenics as a result of the recent acquisition of the iviGene Corporation. IVIAT, or In Vivo Induced Antigen Technology, is a unique, patented discovery platform designed to identify genes of pathogenic bacteria that are specifically expressed during actual human infections. Dr. Robert Zahradnik, Oragenics' president and CEO stated, "The IVIAT technology has proven its ability to identify novel targets for a number of infectious agents, including Vibrio cholerae, Escherichia coli, and Pseudomonas aeruginosa. The resurgence of tuberculosis, especially tied to the emergence of multi-drug resistant strains of the disease, highlights the pressing global need for new diagnostic tests and therapeutic agents."
Initial funding for this TB project was provided through a competitive Small Business Innovative Research (SBIR) grant from the National Institutes of Research. The company expects to continue the development of this potentially crucial technology through the gene target validation phase, preclinical studies and initial clinical trials for a new diagnostic test and for a vaccine against TB. Oragenics' scientists also plan to further utilize its patented IVIAT platform technology to discover unique gene targets for a number of other serious and dangerous human infectious diseases.
Additional funding will be necessary to exploit the opportunity described above and to continue the Company's operations in the future. Oragenics, Inc. announced that the early exercise of stock warrants by a member of the company's Board of Directors has brought $420,000 into the company. When combined with existing cash, this additional funding, reduced by a current monthly burn rate estimated at $150,000, should result in the company having sufficient funding through first quarter 2007.
IVIAT works like a DNA expression library or a RNA microarray. Much like a RNA:DNA array, you simply put tissue culture media/cell extracts over a coated substrate or in this case human sera. IVIAT avoids the use of animal models by using serum from patients who have experienced disease caused by the pathogen of interest. By pooling sera, they can find the widest possible array of antigens produced during different stages of infection. The pooled serum is absorbed with whole cells and cellular extracts prepared from the pathogen grown in vitro. The resulting adsorbed serum contains the subpopulation of antibodies reactive against in vivo induced antigens. This adsorbed serum is used to probe an inducible expression library containing DNA from the pathogen of interest cloned into an appropriate host such as Escherichia coli. Reactive clones contain a DNA fragment from the pathogen that encodes an in vivo antigen. This is quite a development for the field, given that if they can stream line the time it takes into patient treatment times; I can see a revolution in how systemic bacterial infections are fought. Keep an eye on this one; if they can show reproducibility, the market impact is endless.
ONI closed AMEX trading today down 1 cent per share to $1.26.
Monday, December 04, 2006
Micromet Surges on Milestone
Micromet surged 135% Monday after the biotech got a $10 million milestone payment from Serono on the company's adecatumumab treatment in metastatic breast cancer and prostate cancer.
The Carlsbad, Calif., company said it got the milestone payment on the completion of two Phase 2 clinical trials using the drug.
Adecatumumab is a human monoclonal antibody targeting tumor cells overexpressing the epithelial cell adhesion molecule. Micromet and Serono reported final data for the two Phase 2 studies on Oct. 2. The compound originated at Micromet and is being developed in collaboration between the companies.
What is it? How does the antibody work?
Adecatumumab is specifically targeted to epithelial cell adhesion molecule, which is overexpressed on many tumor cell types. The molecule helps tumor cells migrate and may promote tumor proliferation. It's mechanism of action is mediating antibody dependent cellular cytotoxicity (ADCC); tumor cells covered witht the antibody are essentially yelling out "hello immune system!!!" HELLO! COME KILL ME".
Shares rose $2.94 to $4.96. (MITI)is trading at this hour down a bit to $3.86.
The Carlsbad, Calif., company said it got the milestone payment on the completion of two Phase 2 clinical trials using the drug.
Adecatumumab is a human monoclonal antibody targeting tumor cells overexpressing the epithelial cell adhesion molecule. Micromet and Serono reported final data for the two Phase 2 studies on Oct. 2. The compound originated at Micromet and is being developed in collaboration between the companies.
What is it? How does the antibody work?
Adecatumumab is specifically targeted to epithelial cell adhesion molecule, which is overexpressed on many tumor cell types. The molecule helps tumor cells migrate and may promote tumor proliferation. It's mechanism of action is mediating antibody dependent cellular cytotoxicity (ADCC); tumor cells covered witht the antibody are essentially yelling out "hello immune system!!!" HELLO! COME KILL ME".
Shares rose $2.94 to $4.96. (MITI)is trading at this hour down a bit to $3.86.
Sunday, December 03, 2006
Pfizer ends cholesterol-drug development: Halts Clinical Trial
Torcetrapib tests halted on patient-safety concerns:
BOSTON-- Pfizer Inc. said it has halted clinical trials and development of its
HDL, cholesterol by 55% to 60% and lowered bad, or LDL, cholesterol by 10% to 15% relative to patients who were taking only Lipitor.
Joseph Feczko, Pfizer's chief medical officer, said then that the data supported "our fundamental premise: this innovative medicine really can 'do both' and manage total cholesterol successfully."
At the same time, the company said data showed that patients using the torcetrapib/Lipitor combination experienced slightly higher systolic blood pressure than those who took Lipitor alone. Pfizer emphasized the data at that point were not yet complete and still needed further analysis.
According to published reports Sunday, Pfizer was conducting a test of 15,000 patients, half of which took the drug combination with the rest taking Lipitor alone. Eighty-two of the patients taking the combination died, while 51 died taking just Lipitor, according to reports.
The drug company had been developing the combination as a potential successor to Lipitor, which loses patent protection as soon as 2010. Lipitor is the world's top-selling branded prescription drug, with 2005 sales of $12.9 billion, according to IMS Health.
In its latest statement, Pfizer's chief executive, Jeffrey B. Kindler, said the recommendation from the monitoring board was "surprising and disappointing."
Nonetheless, the executive affirmed Pfizer's financial estimates for 2006.
The company expects "high-single-digit average growth" in adjusted earnings over the next two years. A survey of analysts by Thomson First Call produced consensus estimates of profit of $2.05 a share for 2006 and $2.17 for 2007, compared with $2.02 in 2005.
It said it expects revenue in 2007 and 2008 to be comparable with the 2006 figure and then return to growth in 2009. First Call's estimate for 2006 is $48.07 billion against 2005's $51.3 billion.
And it affirmed that it expects to introduce about six new products a year starting in 2010.
The company last week said it planned to cut about 20% of its sales force as part of its restructuring effort.
Pfizer shares closed on Friday up 37 cents, or 1.4%, at $27.86.
What is and how does it work?
Torcetrapib is a cholesterol lowering drug based on the strategy of actively inhibitiing cholesteryl ester transfer protein (CETP). CETP is a plasma glycoprotein
that facilitates the transfer of cholesteryl esters from HDL cholesterol to apolipoprotein B–containing lipoproteins.
Humans with CETP deficiency due to molecular defects in the CETP gene have markedly elevated plasma levels of HDL cholesterol ("good cholesterol")and apolipoprotein A-I,
leading to the concept that CETP inhibition might increase HDL cholesterol
levels.
In animal models, inhibition of CETP by monoclonal antibodies, antisense oligonucleotides,small molecules, or vaccine induced antibodies has resulted in increased HDL cholesterol levels. In addition, a small-molecule inhibitor
of CETP has been shown to increase HDL cholesterol levels to a moderate extent in healthy persons with normal HDL cholesterol levels.
The clinical trial was designed to examine the effects of this novel CETP inhibitor, (torcetrapib).
BOSTON-- Pfizer Inc. said it has halted clinical trials and development of its
HDL, cholesterol by 55% to 60% and lowered bad, or LDL, cholesterol by 10% to 15% relative to patients who were taking only Lipitor.
Joseph Feczko, Pfizer's chief medical officer, said then that the data supported "our fundamental premise: this innovative medicine really can 'do both' and manage total cholesterol successfully."
At the same time, the company said data showed that patients using the torcetrapib/Lipitor combination experienced slightly higher systolic blood pressure than those who took Lipitor alone. Pfizer emphasized the data at that point were not yet complete and still needed further analysis.
According to published reports Sunday, Pfizer was conducting a test of 15,000 patients, half of which took the drug combination with the rest taking Lipitor alone. Eighty-two of the patients taking the combination died, while 51 died taking just Lipitor, according to reports.
The drug company had been developing the combination as a potential successor to Lipitor, which loses patent protection as soon as 2010. Lipitor is the world's top-selling branded prescription drug, with 2005 sales of $12.9 billion, according to IMS Health.
In its latest statement, Pfizer's chief executive, Jeffrey B. Kindler, said the recommendation from the monitoring board was "surprising and disappointing."
Nonetheless, the executive affirmed Pfizer's financial estimates for 2006.
The company expects "high-single-digit average growth" in adjusted earnings over the next two years. A survey of analysts by Thomson First Call produced consensus estimates of profit of $2.05 a share for 2006 and $2.17 for 2007, compared with $2.02 in 2005.
It said it expects revenue in 2007 and 2008 to be comparable with the 2006 figure and then return to growth in 2009. First Call's estimate for 2006 is $48.07 billion against 2005's $51.3 billion.
And it affirmed that it expects to introduce about six new products a year starting in 2010.
The company last week said it planned to cut about 20% of its sales force as part of its restructuring effort.
Pfizer shares closed on Friday up 37 cents, or 1.4%, at $27.86.
What is and how does it work?
Torcetrapib is a cholesterol lowering drug based on the strategy of actively inhibitiing cholesteryl ester transfer protein (CETP). CETP is a plasma glycoprotein
that facilitates the transfer of cholesteryl esters from HDL cholesterol to apolipoprotein B–containing lipoproteins.
Humans with CETP deficiency due to molecular defects in the CETP gene have markedly elevated plasma levels of HDL cholesterol ("good cholesterol")and apolipoprotein A-I,
leading to the concept that CETP inhibition might increase HDL cholesterol
levels.
In animal models, inhibition of CETP by monoclonal antibodies, antisense oligonucleotides,small molecules, or vaccine induced antibodies has resulted in increased HDL cholesterol levels. In addition, a small-molecule inhibitor
of CETP has been shown to increase HDL cholesterol levels to a moderate extent in healthy persons with normal HDL cholesterol levels.
The clinical trial was designed to examine the effects of this novel CETP inhibitor, (torcetrapib).
Friday, December 01, 2006
eGene Announces Initial Product Test Milestone of Its Carbohydrate Analyzer
eGene's trading chart for today:
IRVINE, Calif.--eGene Inc. (OTCBB:EGEI - News), developer of revolutionary high-performance bio-analytical instruments, announced today that a new instrument has been developed for carbohydrate analysis and sequencing. The fully functional system has been tested by Prof. Andras Guttman, Marie Curie Chair of the European Commission, head of the Horvath Laboratory of Bioseparation Sciences in the University in Innsbruck, Austria.
Prof. Andras Guttman, a known expert in carbohydrate analysis, has been collaborating with eGene in the development of the multicapillary carbohydrate analyzer. Initial result of the test will be presented at the Latin American Capillary Electrophoresis Conference (LACE 2006) at Queretaro, Mexico (Dec. 2-5, 2006).
Professor Guttman noted: "eGene's new Carbohydrate Analyzer provides rapid and high resolution analysis of complex sugars, and holds the promise of becoming the first automated carbohydrate sequencer. The automated, multicapillary electrophoresis technology platform will support numerous applications in proteomics research for the biotechnology, pharmaceutical (drug development) and food analysis industries."
Mr. Varouj Amirkhanian, EVP/Director of R&D at eGene, noted: "The new carbohydrate analyzer was developed based on our patented multichannel fluorescence detection technology. It provides compact, automated, high throughput digital detection for the analysis of simple and complex carbohydrate mixtures. It saves time and material cost, and it will as well provide much higher resolving power than the currently used traditional slab gel electrophoresis or HPLC type devices on the market."
Dr. Ming Liu, CEO of eGene, noted: "Carbohydrates formerly considered as storehouses for energy or structural material in cell membranes now appear to play a significant role in important biological functions such as pathogen recognition and ovum fertilization. The new carbohydrate analyzer is the next generation bioanalyzer that has been developed by eGene's R&D team. We plan to launch the product in early 2007. eGene is currently starting early marketing and worldwide commercialization of the system."
The Scripps Research Institute Enters Major Five-Year $100 Million Collaboration With Pfizer Inc.
LA JOLLA, Calif.--The Scripps Research Institute today announced it has entered into a five year research collaboration with Pfizer Global Research and Development to advance scientific knowledge of uncured diseases and novel ways to treat them, making full use of emerging technologies and resident talent from both organizations. Under the terms of the agreement, Pfizer will pay Scripps Research $100 million over a five year period, during which scientists from Pfizer and the Institute will work together to identify and perform specific projects of mutual interest.
PFE closed friday's trading at 27.86 or up 37 cents per share.
Scripps is a private research institute here in La Jolla, CA. There are a lot of great minds there.
PFE closed friday's trading at 27.86 or up 37 cents per share.
Scripps is a private research institute here in La Jolla, CA. There are a lot of great minds there.
Subscribe to:
Posts (Atom)
