Glutoxim is a representative of thiopoietins, a new class of pharmaceuticals possessing a
modulating effect on intracellular processes of thiol metabolism [SH groups containing sulfur and hydrogen atoms]playing an important role in the regulation of genetic and metabolic processes in cells and tissues.
The drug’s mechanism of action consists in regulated escalation of redox state of cells. The new
level of redox systems and of dynamics of phosphorylation of signal-transmitting system key
proteins and transcription factors, primarily of immunocompetent cells, determines the
immunomodulating and systemic cytoprotective effect of the drug. [It keeps the inside of the cell in a reduced state, ready to lose electrons and bind up free radicals]
Glutoxim acts differently on normal cells, where it stimulates proliferation and differentiation [growth and growing into a specialized cell that cannot change again],
and on transformed ones, where it induces apoptosis (genetically programmed cell death). The
main immunophysiological properties of the drug include its high tropism to the cells of central
immunity organs and of the lymphoid tissue system, enhancement of spinal hemopoiesis
(erythropoiesis, lymphopoiesis and granulocyto-monocytopoiesis)[formation of new cells, red blood cells, white blood cells], activation of the phagocytosis [cell eating]
system (including cases of immune deficiency), restoration of neutrophil, monocyte and
lymphocyte count in peripheral blood and of tissue macrophage functional activity. The most
important immunobiochemical effects of the drug include stimulation of cascade mechanisms of
phosphate modification of the signal-transmitting system key proteins, initiation of the cytokine
system, [communication between cells--cytokine are small proteins that elicit very specific cellular reactions] including endogenous synthesis of interleukine 1, interleukine 6, tumour necrosis factor, interferons, erythropoietin, and reproduction of interleukine 2 effects by inducing expression of its receptors.
NVLT closed down 3 cents in today's trading to 0.50 cents per share in relatively normal trading volume.
Note: NVLT today announced that it was issued U.S. Pat. No. 7,371,411 by the U.S. Patent and Trademark Office extending the composition and method of use claims relating to NOV-002, Novelos’ lead compound in an ongoing pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track. NOV-002 has also demonstrated positive results in Phase 2 trials for other oncology indications.
Novelos has a commanding intellectual property position around its oxidized glutathione-based product platform, which currently includes 6 issued U.S. patents, 2 European patents (that have gone national) and 1 Japanese patent. Overall, Novelos filed more than thirty patent applications worldwide. Together, these will provide broad and long-lasting coverage, up to at least 2019, encompassing composition of matter, method of use and manufacturing for Novelos’ compounds.
Monday, June 30, 2008
Sunday, June 29, 2008
I'm having some down time..
Our mascot, UGA VI died yesterday. It's a sad time and it's right before the season kicks off.
RIP UGA.
more NVLT tomorrow.
RIP UGA.
more NVLT tomorrow.
Update: NVLT
I'm in the process of legging the ground work of NVLT's product pipeline. I can get more in depth tomorrow when I can gain access to scientific journals at work.
Some Background First:
The Company was incorporated in June 1996 as AVAM International, Inc. In October 1998, Novelos Therapeutics, Inc., a newly incorporated entity, merged into AVAM, and the name of AVAM was changed to Novelos Therapeutics, Inc. In 2005, the Company completed a two-step reverse merger with Common Horizons, Inc., and its wholly-owned subsidiary Nove Acquisition, Inc. Following the merger, the surviving company was Novelos Therapeutics, Inc. The Company is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, its lead compound, is currently in Phase 3 development for lung cancer under a Special Protocol Assessment and Fast Track. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is also being developed for acute radiation injury. NOV-205, the Company's second compound, is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in Russia where they were originally developed.
Ok, so what does glutathione based compounds mean?
IN the body, glutathione acts much like a scavenger, finding and neutralizing free oxygen species, such as hydrogen peroxide. It's a small molecule produced in every cell of the body. It has three amino acids. It originates from three primary amino acids in the body: glutamate, cysteine and glycine. Glutathione is actually a tripeptide made up the amino acids gamma-glutamic acid, cysteine, and glycine. The primary biological function of glutathione is to act as a non-enzymatic reducing agent to help keep cysteine thiol side chains in a reduced state on the surface of proteins. Glutathione is also used to prevent oxidative stress in most cells and helps to trap free radicals that can damage DNA and RNA. There is a direct correlation with the speed of aging and the reduction of glutathione concentrations in intracellular fluids. As individuals grow older, glutathione levels drop, and the ability to detoxify free radicals decreases.
NOV-002: (from Novelos website: www.novelos.com)
NOV-002, the lead compound, acts as a chemoprotectant and a chemopotentiator. NOV-002 was approved in Russia where it is marketed by PharmaBAM under the trade name Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with cisplatin-based chemotherapy increased the one-year survival of advanced NSCLC patients from 17% to 63% (p < href="http://www.glutoxim.ru/" target="_blank">Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with
Post is getting long. Repost with more info shortly. Reading the mechanism of action now.
Some Background First:
The Company was incorporated in June 1996 as AVAM International, Inc. In October 1998, Novelos Therapeutics, Inc., a newly incorporated entity, merged into AVAM, and the name of AVAM was changed to Novelos Therapeutics, Inc. In 2005, the Company completed a two-step reverse merger with Common Horizons, Inc., and its wholly-owned subsidiary Nove Acquisition, Inc. Following the merger, the surviving company was Novelos Therapeutics, Inc. The Company is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, its lead compound, is currently in Phase 3 development for lung cancer under a Special Protocol Assessment and Fast Track. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is also being developed for acute radiation injury. NOV-205, the Company's second compound, is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in Russia where they were originally developed.
Ok, so what does glutathione based compounds mean?
IN the body, glutathione acts much like a scavenger, finding and neutralizing free oxygen species, such as hydrogen peroxide. It's a small molecule produced in every cell of the body. It has three amino acids. It originates from three primary amino acids in the body: glutamate, cysteine and glycine. Glutathione is actually a tripeptide made up the amino acids gamma-glutamic acid, cysteine, and glycine. The primary biological function of glutathione is to act as a non-enzymatic reducing agent to help keep cysteine thiol side chains in a reduced state on the surface of proteins. Glutathione is also used to prevent oxidative stress in most cells and helps to trap free radicals that can damage DNA and RNA. There is a direct correlation with the speed of aging and the reduction of glutathione concentrations in intracellular fluids. As individuals grow older, glutathione levels drop, and the ability to detoxify free radicals decreases.
NOV-002: (from Novelos website: www.novelos.com)
NOV-002, the lead compound, acts as a chemoprotectant and a chemopotentiator. NOV-002 was approved in Russia where it is marketed by PharmaBAM under the trade name Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with cisplatin-based chemotherapy increased the one-year survival of advanced NSCLC patients from 17% to 63% (p < href="http://www.glutoxim.ru/" target="_blank">Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with
Post is getting long. Repost with more info shortly. Reading the mechanism of action now.
Wednesday, May 14, 2008
F*** off Virus!
Im back!!! A very long illness but I'm back in the game. Now let me see if I can get this thing updated.
Friday, February 29, 2008
Evil Alcohol
The update on NVLT is on it's way, but I went through a week of a binge vodka tonic action. Not good and got some sort of evil death virus. I'm on the rebound now so check back soon. Thanks.
Thursday, February 21, 2008
Coming Today: NVLT
NVLT:
Novelos Therapeutics, Inc., a biopharmaceutical company, commercializes oxidized glutathione-based compounds for the treatment of cancer and hepatitis in the United States. Its products in development include NOV-002, which acts as a chemoprotectant and an immunomodulator; and NOV-205, which acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-002, a small-molecule formulation of a natural metabolite, is in Phase III development for lung cancer, as well as in Phase II development for chemotherapy-resistant ovarian cancer and early-stage breast cancer. NOV-002 is also being developed for acute radiation injury. NOV-205, a small-molecule formulation of oxidized glutathione and inosine, is in Phase Ib development for the treatment of chronic hepatitis C. Novelos Therapeutics is based in Newton, Massachusetts.
I need to do some research on the compounds--eg how they work etc, and will post. Very interesting mechanisms of action.
Novelos Therapeutics, Inc., a biopharmaceutical company, commercializes oxidized glutathione-based compounds for the treatment of cancer and hepatitis in the United States. Its products in development include NOV-002, which acts as a chemoprotectant and an immunomodulator; and NOV-205, which acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-002, a small-molecule formulation of a natural metabolite, is in Phase III development for lung cancer, as well as in Phase II development for chemotherapy-resistant ovarian cancer and early-stage breast cancer. NOV-002 is also being developed for acute radiation injury. NOV-205, a small-molecule formulation of oxidized glutathione and inosine, is in Phase Ib development for the treatment of chronic hepatitis C. Novelos Therapeutics is based in Newton, Massachusetts.
I need to do some research on the compounds--eg how they work etc, and will post. Very interesting mechanisms of action.
Saturday, January 26, 2008
I'm Back! Amgen reports lower sales
Amgen Inc. reported flat fourth-quarter earnings attributable to a 25% drop in sales for one of its top-selling products, the anemia drug Aranesp.
The Thousand Oaks, Calif., biotechnology giant also issued an updated financial forecast.
Amgen shares closed up 4.7% at $48.28 in after-hours trading.
Amgen earned $835 million, or 76 cents a share, in the quarter compared with $833 million, or 71 cents, in the year-earlier period. Average shares outstanding fell 7.1% to 1.09 billion.
Both periods reflected various charges. Adjusted earnings were $1 a share versus 90 cents.
Revenue declined 2% to $3.75 billion from $3.84 billion.
Still, Amgen's results topped Wall Street expectations. A poll of analysts by Thomson Financial pegged the results at 97 cents a share of earnings on $3.54 billion of revenue.
The company said it now expects to earn an adjusted $4 to $4.30 a share on revenue of $14.2 billion to $14.6 billion in 2008. A Thomson Financial poll has Amgen earning $4.37 a share on revenue of $14.49 billion.
Sales of Amgen's top-selling Aranesp dropped to $827 million. Epogen, a forerunner to Aranesp, also saw sales decline, down 3% to $638 million. The drugs, which are based on the hormone erythropoietin, are used to treat anemia associated with either kidney failure or chemotherapy.
Last year "was Amgen's most challenging year," Chairman and Chief Executive Officer Kevin Sharer said in a statement. "Despite the unexpected reduction in revenues of our erythropoietin products, we delivered earnings per share very close to the low end of our original guidance."
Sales of both drugs have been under pressure following changes in Medicare reimbursement policy and a move by the Food and Drug Administration in November to strengthen safety warnings in the drugs' prescribing information. The drugs are also beginning to face competition from generic versions overseas.
Amgen said Thursday that it is still in talks with the FDA about further revisions to the products' labels. It added it was also discussing labeling changes with European regulators.
On a conference call with investors Thursday night, Amgen management said that going into 2008, Aranesp sales appeared to be "flat but stable."
They said the introduction of generic versions of the drug overseas has so far resulted only in "mild price erosion" for Aranesp. They added, however, than any additional labeling or reimbursement changes could further hurt sales.
Earlier this week, Johnson & Johnson which markets Epogen under the names Procrit and Eprex, reported fourth-quarter sales of those drugs also were down 25% from the previous year.
In August, Amgen said it planned to slash 14%, or about 2,600, of its workers because of a slowdown in sales for its anemia drugs.
Sales of Amgen's other drugs were mixed.
Combined sales of Neulasta and Neupogen showed solid growth, rising 9% to $1.12 billion from a year earlier. The drugs help ward off infection in patients undergoing chemotherapy.
Sales of Amgen's new colorectal-cancer drug Vectibix, however, saw sales dip to $33 million from $41 million in third-quarter 2007. Amgen attributed the slide to a decline in segment share and size.
The Thousand Oaks, Calif., biotechnology giant also issued an updated financial forecast.
Amgen shares closed up 4.7% at $48.28 in after-hours trading.
Amgen earned $835 million, or 76 cents a share, in the quarter compared with $833 million, or 71 cents, in the year-earlier period. Average shares outstanding fell 7.1% to 1.09 billion.
Both periods reflected various charges. Adjusted earnings were $1 a share versus 90 cents.
Revenue declined 2% to $3.75 billion from $3.84 billion.
Still, Amgen's results topped Wall Street expectations. A poll of analysts by Thomson Financial pegged the results at 97 cents a share of earnings on $3.54 billion of revenue.
The company said it now expects to earn an adjusted $4 to $4.30 a share on revenue of $14.2 billion to $14.6 billion in 2008. A Thomson Financial poll has Amgen earning $4.37 a share on revenue of $14.49 billion.
Sales of Amgen's top-selling Aranesp dropped to $827 million. Epogen, a forerunner to Aranesp, also saw sales decline, down 3% to $638 million. The drugs, which are based on the hormone erythropoietin, are used to treat anemia associated with either kidney failure or chemotherapy.
Last year "was Amgen's most challenging year," Chairman and Chief Executive Officer Kevin Sharer said in a statement. "Despite the unexpected reduction in revenues of our erythropoietin products, we delivered earnings per share very close to the low end of our original guidance."
Sales of both drugs have been under pressure following changes in Medicare reimbursement policy and a move by the Food and Drug Administration in November to strengthen safety warnings in the drugs' prescribing information. The drugs are also beginning to face competition from generic versions overseas.
Amgen said Thursday that it is still in talks with the FDA about further revisions to the products' labels. It added it was also discussing labeling changes with European regulators.
On a conference call with investors Thursday night, Amgen management said that going into 2008, Aranesp sales appeared to be "flat but stable."
They said the introduction of generic versions of the drug overseas has so far resulted only in "mild price erosion" for Aranesp. They added, however, than any additional labeling or reimbursement changes could further hurt sales.
Earlier this week, Johnson & Johnson which markets Epogen under the names Procrit and Eprex, reported fourth-quarter sales of those drugs also were down 25% from the previous year.
In August, Amgen said it planned to slash 14%, or about 2,600, of its workers because of a slowdown in sales for its anemia drugs.
Sales of Amgen's other drugs were mixed.
Combined sales of Neulasta and Neupogen showed solid growth, rising 9% to $1.12 billion from a year earlier. The drugs help ward off infection in patients undergoing chemotherapy.
Sales of Amgen's new colorectal-cancer drug Vectibix, however, saw sales dip to $33 million from $41 million in third-quarter 2007. Amgen attributed the slide to a decline in segment share and size.
Saturday, November 03, 2007
Slow Posting on my part
I had a death in the family and have not thought about posting. I realize some of you come here to read daily, and I'm trying to get back to posting daily, but instead of quantity i'll give you quality. Thank you for stopping by and updates [I'm planning] will resume on Monday, Nov. 5.
Friday, October 12, 2007
Wyeth gets hit with multi million dollar verdict
A Nevada jury awarded $134.5 million to three women who claimed Wyeth's hormone-therapy drugs caused their breast cancer.
Jurors awarded compensatory damages to plaintiffs Arlene Rowatt, Jeraldine Scofield and Pamela Forrester after finding Wyeth was negligent, that its drugs were defective and that the company concealed a material fact about the products' safety. All these issues were a cause of injury or damage to the women, the jury said.
The jury, which also found that Wyeth acted with malice or fraud, awarded damages of $43.5 million to Ms. Scofield, $47.5 million to Ms. Forrester and $43.5 million to Ms. Rowatt.
A Wyeth spokesman declined to comment because the case "is not yet complete," citing a hearing on punitive damages scheduled for today. The plaintiffs' law firm also declined comment, citing today's hearing.
The suit, filed in Washoe County District Court in Reno, is one of some 5,300 hormone-replacement cases filed against Wyeth on behalf of 7,900 plaintiffs, according to the pharmaceutical maker. The complaints allege personal injury as a result of the plaintiffs' use of one or more of Wyeth's hormone- or estrogen-therapy products, including Prempro and Premarin, used to treat menopausal symptoms.
The Reno case is the seventh to reach a verdict since trials began last year. Three of the other six trials resulted in verdicts in favor of Wyeth. Of those favoring plaintiffs, one was overturned and judgment entered in favor of Wyeth, and verdicts in the two others were thrown out and new trials ordered by judges. None of the victorious plaintiffs in those cases had been awarded damages greater than $3 million.Three other cases also have been dismissed by courts on summary judgment, and a dozen other cases that had been set for trial were voluntarily withdrawn by plaintiffs before trial.
Wall Street didn't appear rattled by the verdict. Wyeth's shares, which have been in a slump lately for reasons related to the company's pipeline and generic drugs, were down 38 cents to $45.78 in 4 p.m. composite trading on the New York Stock Exchange.
Deutsche Bank drug analyst Barbara Ryan said that it is too early in the string of litigation to presume this case would be the start of a trend, and that in general the hormone-replacement cases appear tougher for plaintiffs to win than past "fen-phen" diet-drug litigation against the company. Wyeth is an investment-banking client of Deutsche Bank.
Lawyers for the Madison, N.J., drug maker have argued that the company clearly warned users that there was a slightly increased risk of breast cancer from taking Prempro, which was first marketed in 1995. In a recent filing with the Securities and Exchange Commission, the company said it hasn't established any litigation-reserve fund for its hormone-therapy litigation.
Howard Erichson, a professor at Seton Hall law school in New Jersey, said it is common for surprisingly large damage awards to be lowered. But, he added, "With thousands of cases remaining to be tried, it's a scary thing to know that juries don't like your argument."
Another, "I don't want to take responsibility for my actions" lawsuit(s) there has been research since the 1980's that suggested estrogen therapy has an incidence of breast cancers. This settlement is ridiculous.
Jurors awarded compensatory damages to plaintiffs Arlene Rowatt, Jeraldine Scofield and Pamela Forrester after finding Wyeth was negligent, that its drugs were defective and that the company concealed a material fact about the products' safety. All these issues were a cause of injury or damage to the women, the jury said.
The jury, which also found that Wyeth acted with malice or fraud, awarded damages of $43.5 million to Ms. Scofield, $47.5 million to Ms. Forrester and $43.5 million to Ms. Rowatt.
A Wyeth spokesman declined to comment because the case "is not yet complete," citing a hearing on punitive damages scheduled for today. The plaintiffs' law firm also declined comment, citing today's hearing.
The suit, filed in Washoe County District Court in Reno, is one of some 5,300 hormone-replacement cases filed against Wyeth on behalf of 7,900 plaintiffs, according to the pharmaceutical maker. The complaints allege personal injury as a result of the plaintiffs' use of one or more of Wyeth's hormone- or estrogen-therapy products, including Prempro and Premarin, used to treat menopausal symptoms.
The Reno case is the seventh to reach a verdict since trials began last year. Three of the other six trials resulted in verdicts in favor of Wyeth. Of those favoring plaintiffs, one was overturned and judgment entered in favor of Wyeth, and verdicts in the two others were thrown out and new trials ordered by judges. None of the victorious plaintiffs in those cases had been awarded damages greater than $3 million.Three other cases also have been dismissed by courts on summary judgment, and a dozen other cases that had been set for trial were voluntarily withdrawn by plaintiffs before trial.
Wall Street didn't appear rattled by the verdict. Wyeth's shares, which have been in a slump lately for reasons related to the company's pipeline and generic drugs, were down 38 cents to $45.78 in 4 p.m. composite trading on the New York Stock Exchange.
Deutsche Bank drug analyst Barbara Ryan said that it is too early in the string of litigation to presume this case would be the start of a trend, and that in general the hormone-replacement cases appear tougher for plaintiffs to win than past "fen-phen" diet-drug litigation against the company. Wyeth is an investment-banking client of Deutsche Bank.
Lawyers for the Madison, N.J., drug maker have argued that the company clearly warned users that there was a slightly increased risk of breast cancer from taking Prempro, which was first marketed in 1995. In a recent filing with the Securities and Exchange Commission, the company said it hasn't established any litigation-reserve fund for its hormone-therapy litigation.
Howard Erichson, a professor at Seton Hall law school in New Jersey, said it is common for surprisingly large damage awards to be lowered. But, he added, "With thousands of cases remaining to be tried, it's a scary thing to know that juries don't like your argument."
Another, "I don't want to take responsibility for my actions" lawsuit(s) there has been research since the 1980's that suggested estrogen therapy has an incidence of breast cancers. This settlement is ridiculous.
Thursday, September 20, 2007
FDA approves label expansion for medimmune's flumist
MedImmune, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of FluMist(R) (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of disease caused by influenza A and B viruses in individuals two to 49 years of age. Only one manufacturer had previously been licensed in the United States to produce influenza vaccine for children under four years of age.
FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
MedImmune is wholly owned by AstraZeneca. AZN ended today's trading all square at 48.21 a share.
FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
MedImmune is wholly owned by AstraZeneca. AZN ended today's trading all square at 48.21 a share.
Wednesday, September 19, 2007
Stocks soar on fed news....Will BioTech take advantage?
A jubilant Wall Street barreled higher Tuesday after the Federal Reserve cut its benchmark interest rate by a larger-than-expected half percentage point. The Dow Jones industrial average reacted by surging 335 points -- its biggest one-day point jump in nearly five years.
Although some investors hoped for a rate cut of that magnitude, most were betting on a smaller, quarter-point cut in the federal funds rate. The Fed responded to the spilling of credit market problems into the rest of the economy by saying, "the tightening of credit conditions has the potential to intensify the housing (market) correction and to restrain economic growth more generally."
The Fed lowered the benchmark fed funds rate to 4.75 percent after keeping it unchanged for more than a year and not lowering the rate since 2003. It also reduced the discount rate -- what it charges banks borrowing from its discount window -- by a half percentage point to 5.25 percent. On Aug. 17, the central bank lowered the discount rate by a half-point to help keep cash moving in the U.S. banking system.
The central bank's decision and the wording of its accompanying economic assessment gratified a market that plunged during August amid fears that credit market tightness, spawned by a continuum of mortgage defaults and delinquencies, would send the economy toward recession.
There was no direct signal in the Fed's statement that it would make further rate cuts. It said "some inflation risks remain" and that it will keep monitoring inflation developments. Still, it did not call inflation its "predominant policy concern" as it did after holding rates steady in early August.
"What it says to me is you had a major shift in the last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity," said Jerry Webman, chief economist at Oppenheimer Funds Inc.
Big Pharma has a lot of cash, will they spend it? ANDS sure could use a bolster of milestone payments for it's pipeline.
I love the quote "last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity,"
I've been trying to get to full liquidity for a long, long, time.
Although some investors hoped for a rate cut of that magnitude, most were betting on a smaller, quarter-point cut in the federal funds rate. The Fed responded to the spilling of credit market problems into the rest of the economy by saying, "the tightening of credit conditions has the potential to intensify the housing (market) correction and to restrain economic growth more generally."
The Fed lowered the benchmark fed funds rate to 4.75 percent after keeping it unchanged for more than a year and not lowering the rate since 2003. It also reduced the discount rate -- what it charges banks borrowing from its discount window -- by a half percentage point to 5.25 percent. On Aug. 17, the central bank lowered the discount rate by a half-point to help keep cash moving in the U.S. banking system.
The central bank's decision and the wording of its accompanying economic assessment gratified a market that plunged during August amid fears that credit market tightness, spawned by a continuum of mortgage defaults and delinquencies, would send the economy toward recession.
There was no direct signal in the Fed's statement that it would make further rate cuts. It said "some inflation risks remain" and that it will keep monitoring inflation developments. Still, it did not call inflation its "predominant policy concern" as it did after holding rates steady in early August.
"What it says to me is you had a major shift in the last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity," said Jerry Webman, chief economist at Oppenheimer Funds Inc.
Big Pharma has a lot of cash, will they spend it? ANDS sure could use a bolster of milestone payments for it's pipeline.
I love the quote "last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity,"
I've been trying to get to full liquidity for a long, long, time.
Tuesday, September 11, 2007
Imclone clinical trial endpoint met, Stock gains momentum
NEW YORK - Positive results from a study involving Imclone Systems Inc.'s cancer drug Erbitux is raising the company's market value by nearly a quarter Tuesday, but some think it will take a lot longer before any effect is seen on the company's bottomline.
A study released this morning from Imclone's overseas marketing partner for Erbitux, Merck KGaA (MRK.XE), met its primary endpoint of increased survival rates in treating advanced non-small cell lung cancer when used in combination with chemotherapy. That type of lung cancer currently has limited treatment options and would add another market for the drug.
Remember that Erbitux was one of the first targeted drug therapies using monoclonal antibodies. Erbitux is targeted to the epidermal growth factor receptor family of proteins that are located on the cell surface. Once bound, the antibody neutralizes the signaling pathways that the receptors use to tell the cell to grow.
IMCL stock closed trading today +6.97 or 18% in afternoon trading and another 23 cents upward in after hours trading.
A study released this morning from Imclone's overseas marketing partner for Erbitux, Merck KGaA (MRK.XE), met its primary endpoint of increased survival rates in treating advanced non-small cell lung cancer when used in combination with chemotherapy. That type of lung cancer currently has limited treatment options and would add another market for the drug.
Remember that Erbitux was one of the first targeted drug therapies using monoclonal antibodies. Erbitux is targeted to the epidermal growth factor receptor family of proteins that are located on the cell surface. Once bound, the antibody neutralizes the signaling pathways that the receptors use to tell the cell to grow.
IMCL stock closed trading today +6.97 or 18% in afternoon trading and another 23 cents upward in after hours trading.
Wednesday, August 01, 2007
Anadys Drops Hep C Program
Anadys Pharmaceuticals Inc. said it was cutting its workforce by a third and discontinuing further development of ANA380, its drug to treat hepatitis B virus infection.
Anadys said it was halting all work on early discovery projects and will incur a charge of about $0.8 million related to the workforce reduction.
In a filing with U.S. regulators, the company said it was terminating its employment agreement with Chief Scientific Officer Devron Averett, effective Aug. 17. Averett will assume a consultancy role, it added.
Anadys expects the 33 percent workforce reduction to result in annual savings of between $4 million and $5 million.
The company said it would return all rights of the ANA380 compound to Korean pharmaceutical company LG Life Sciences Ltd.
Anadys and LG Life Sciences had entered into a joint development program in April 2004, under which Anadys had marketing rights to the compound in North America, Europe, Japan and some other countries.
Last week, the company said it was discontinuing development of ANA975, its drug to treat hepatitis C virus infection, on safety concerns. It was developing the drug with Swiss drug-maker Novartis.
Anadys said it will focus its resources on two drug candidates, ANA598 for hepatitis C and ANA773 for cancer. With a cash balance of about $69 million, it believes it can carry development of the two drugs forward.
The company posted a second-quarter loss of $7 million, or 24 cents a share, on revenue of $1.3 million. Analysts on average were expecting a loss of 29 cents a share, on revenue of $1.34 million, according to Reuters Estimates.Tuesday, July 24, 2007
Computer Problems are Fixed!!!
My real day time job has been crazy the last 2 months and my computer death at home have prevented me from posting on a regular basis. Work has eased a bit and I have corrected my problem with my computer at home. Regular posting will begin!
Stick around and lets ride the market through the summer.
Stick around and lets ride the market through the summer.
Saturday, June 16, 2007
Multikine gets orphan drug status
CEL-SCI Corporation announced today that its cancer drug Multikine® has been granted orphan-drug designation as neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (head and neck cancer) by the United States Food and Drug Administration (FDA).
An orphan drug is any drug developed under the Orphan Drug Act of January 1983 ("ODA"), a federal law concerning rare diseases (orphan diseases"), defined as diseases affecting fewer than 200,000 people in the United States. In 2003, the leading orphan drug by worldwide sales revenue was Amgen's Erythropeietin (Epogen®), with sales of $2.4bn.
Geert Kersten, CEO of CEL-SCI said, "Receiving orphan-drug designation for Multikine is yet another major achievement for CEL-SCI, following the go-ahead from the FDA earlier this year for the Company's Phase III study in advanced primary head and neck cancer patients and the subsequent raising of substantial funds in April, 2007. We are putting in place all of the pieces required to make this company very successful."
(Amex: CVM) closed friday's trading at 81 cents per share.
Further Reading: A letter to shareholders:
An orphan drug is any drug developed under the Orphan Drug Act of January 1983 ("ODA"), a federal law concerning rare diseases (orphan diseases"), defined as diseases affecting fewer than 200,000 people in the United States. In 2003, the leading orphan drug by worldwide sales revenue was Amgen's Erythropeietin (Epogen®), with sales of $2.4bn.
Geert Kersten, CEO of CEL-SCI said, "Receiving orphan-drug designation for Multikine is yet another major achievement for CEL-SCI, following the go-ahead from the FDA earlier this year for the Company's Phase III study in advanced primary head and neck cancer patients and the subsequent raising of substantial funds in April, 2007. We are putting in place all of the pieces required to make this company very successful."
(Amex: CVM) closed friday's trading at 81 cents per share.
Further Reading: A letter to shareholders:
Dear Fellow Shareholders:
So far 2007 has been an excellent year for CEL-SCI and its cancer product Multikine®. In January we received the US FDA go-ahead for the Phase III clinical trial with Multikine, a huge achievement for any drug, yet an even bigger achievement for a completely new type of drug such as our Multikine. We followed this up with a $15 million commitment to finance the Multikine manufacturing facility in Baltimore, Maryland and another $15 million in equity financing in April. In June we announced that we received orphan drug status from the FDA for Multikine. This designation brings many substantial benefits to the Company. I believe that the opportunity ahead for CEL-SCI is so compelling that I have continued to purchase CEL-SCI stock in the open market.
In talking to investors it has become clear to me that few investors understand the enormous impact that our Multikine will have on the treatment of cancer if we can confirm in our Phase III study the impressive survival results we have seen in our Phase II trial. I believe that a background summary on Multikine is helpful for that reason.
Background Summary on Multikine:
-- The science: The science behind Multikine is based on the premise that
a healthy immune system can cure cancer. When the immune system is
imbalanced or weakened, diseases like cancer occur. Balancing and
strengthening the immune system is thought to be an effective strategy
in fighting cancer.
-- What is Multikine? Multikine is a mixture of naturally occurring
cytokines, substances that regulate the immune system. The patented
Multikine mixture is representative of the mixture of cytokines
produced by a healthy immune system. CEL-SCI scientists have published
in the highly regarded "Journal of Clinical Oncology" that many
different cytokines working together are needed to put in motion the
comprehensive immune response needed to fight cancer. Most other
immunotherapies being developed are based upon the use of only one
cytokine.
-- How is it used? Multikine is the first cancer immunotherapy being
developed as a first line treatment. This means it is administered
prior to any other cancer therapy (e.g. surgery, radiation and/or
chemotherapy) because that is the time when the immune system can still
be fully activated. Once the patient has had surgery or has received
radiation and/or chemotherapy, the immune system is severely weakened
and less able to mount an effective immune response. We believe that
most of the failures of immunotherapy drugs up to now have been the
result of giving immunotherapy after the patient's immune system was
damaged by other cancer therapies.
-- How does it work? Multikine works in two ways:
1. It signals the immune system to mount an effective immune response.
Multikine changes the type of immune cell that attacks the tumor
from a CD-8 cell to a CD-4 cell. This is important because tumors
are able to defend themselves against the normal CD-8 cell attack,
but appear to be unable to defend themselves against the CD-4 cell
attack. The CD-4 cell breaks what is known as "tumor tolerance,"
thereby allowing the immune system to see and attack the tumor.
2. Multikine has been shown to render cancer cells much more
susceptible to radiation and chemotherapy treatments, thereby making
these treatments much more effective.
The combination of both of these is very important because Multikine
will fight the tumor on two fronts, without toxicity.
-- Results: In a Phase II clinical trial, Multikine was shown to increase
overall survival by 33% 3.5 years after the first treatment.
-- Its effect on recurrence of cancer: Chemotherapy, surgery and
radiation do not always succeed in killing all the cancer cells. The
persistence of cancer cells is responsible for cancer recurrence.
Multikine is injected around the tumor and into the local lymph nodes
because those areas are the most likely places for the cancer to recur
if any of the cancer cells survive. Multikine uses the immune system
to kill those cancer cells before they cause tumor recurrence.
-- Safety: Multikine has been shown to be safe and non-toxic in multiple
studies. This was not surprising because Multikine consists of
naturally derived substances given in very small dosages, just as the
body does itself every day.
-- Potentially useful for multiple tumors: Despite the fact that the
Multikine treatment given to each patient is the same (i.e., not
patient specific), the immune response induced by Multikine is
completely targeted to the patient's own tumor. This means that
Multikine may be useful against many different tumors. Multikine has
already shown activity in small studies in cervical dysplasia/neoplasia
and prostate cancer. One of its mechanisms of action suggests that it
should also be developed as an enhancement of radiation and
chemotherapy.
-- Clinical Status: Multikine is currently cleared for a Phase III
clinical trial in the US and Canada in advanced primary head and neck
cancer patients. These are recently diagnosed, not yet treated
patients. Head and neck cancer is an aggressive cancer that accounts
for about 500,000 - 600,000 new annual cases of cancer world-wide.
Advanced primary head and neck cancer patients typically have a 50%
chance of survival three years following the first treatment.
Treatments for newly diagnosed head and neck cancer have not
significantly improved over the last 50 years and therefore constitute
a clear unmet medical need.
The Phase III study, which is designed to prove that Multikine works,
is expected to enroll about 800 advanced primary head and neck cancer
patients worldwide. In its last Phase II clinical trial Multikine
increased overall survival by 33%. The Phase III study will need to
show a 10% increase in overall survival to be successful.
-- Market size: The current Phase III clinical trial pits Multikine plus
the standard of care treatments against the standard of care treatments
alone. A win for the Multikine treatment group would mean that every
patient with advanced primary head and neck cancer is supposed to get
Multikine. This would translate into a market potential of $15
billion.
We believe that Multikine will ultimately be added to the cancer treatments of many solid tumors. This it will have a huge impact on the treatment of cancer because curing more patients with the first cancer treatment will significantly decrease the number of cancer deaths. We thank you for being part of this dream.
As shareholders we truly value your participation in and support of our company. In an effort to improve our image, which has not yet caught up to where the company is today, we are currently redeveloping our corporate identity and redesigning our website. You are our most important advocates and we want your voice to be heard. We would like to collect some personal letters from you that describe why you support CEL-SCI and Multikine, and what your hopes are for Multikine. Our hope is to publish these letters on our website. Please mail these letters to Gavin de Windt, Investor Relations Manager, CEL-SCI Corporation, 8229 Boone Boulevard, Suite 802, Vienna, VA 22182, USA or send it by e-mail to gdewindt@cel-sci.com .
Wednesday, June 13, 2007
Panel Rejects New Weight-Loss Drug
Federal Panel Rejects Sanofi-Aventis Weight-Loss Drug Rimonabant
WASHINGTON-- Federal health advisers unanimously rejected a weight-loss drug Wednesday after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression.
The manufacturer, Sanofi-Aventis SA, further failed to show the drug rimonabant is safe, the panel said.
The back-to-back, 14-0 votes by the expert panel made it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel's advice, but it isn't required to do so.
"There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Dr. Jules Hirsch, a senior physician at New York's Rockefeller University.
SNY fell $1.31 in afternoon trading to close at 43.07 per share. In afterhours trading, the trend continued losing another 59 cents a share.
This is a cannaboid receptor binding drug---yes that one. I will post the mechanism of action soon. It's very interesting how this drug supposedly suppresses appetite.
I have internet connection problems this week, soon to be remedied, so that mechanism will be posted ASAP. thanks.
WASHINGTON-- Federal health advisers unanimously rejected a weight-loss drug Wednesday after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression.
The manufacturer, Sanofi-Aventis SA, further failed to show the drug rimonabant is safe, the panel said.
The back-to-back, 14-0 votes by the expert panel made it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel's advice, but it isn't required to do so.
"There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Dr. Jules Hirsch, a senior physician at New York's Rockefeller University.
SNY fell $1.31 in afternoon trading to close at 43.07 per share. In afterhours trading, the trend continued losing another 59 cents a share.
This is a cannaboid receptor binding drug---yes that one. I will post the mechanism of action soon. It's very interesting how this drug supposedly suppresses appetite.
I have internet connection problems this week, soon to be remedied, so that mechanism will be posted ASAP. thanks.
Tuesday, June 12, 2007
Good Article: Time to get some Genentech?
Genentech shares have nose-dived 16% over the last 6 months--from $89.05 on January 19 to $74.78 on June 7--due, at least in part, to a dearth of positive, stock-moving news. But that decline could now give stock-pickers just the right opportunity to buy.
Proving that point Jennifer Chao, an analyst at Deutsche Bank, says Genentech (nyse: DNA - news - people ) is a smart pickup because of a 52-week low in share price and a compelling valuation.
Also, Chao said there are new developments afoot that could act as catalysts for the stock. "The next 12 months represent major upside to fundamentals with multiple shots on goal," Chao wrote.
She wrote that her analysis shows positive results for the Phase III C-08 adjuvant colon cancer study, assigning a 60% positive outlook on first interim look in the second half of 2007, 75% on second interim look in the first-half of 2008, and 85% on third interim look in the second half of 2008.
A significant positive interim analysis in the second-half of 2007, Chao wrote, would translate into near immediate off-label usage and rapid penetration into adjuvant colon cancer with implications in other off-label indications. Regulatory filing would be anticipated in the first-half of 2008, with approval by late 2008 or early 2009.
Chao upgraded Genentech to "buy" from "hold." In Monday morning trading, shares of the company rose 1%, or 76 cents, to $77.73.
Source: Forbes online
Proving that point Jennifer Chao, an analyst at Deutsche Bank, says Genentech (nyse: DNA - news - people ) is a smart pickup because of a 52-week low in share price and a compelling valuation.
Also, Chao said there are new developments afoot that could act as catalysts for the stock. "The next 12 months represent major upside to fundamentals with multiple shots on goal," Chao wrote.
She wrote that her analysis shows positive results for the Phase III C-08 adjuvant colon cancer study, assigning a 60% positive outlook on first interim look in the second half of 2007, 75% on second interim look in the first-half of 2008, and 85% on third interim look in the second half of 2008.
A significant positive interim analysis in the second-half of 2007, Chao wrote, would translate into near immediate off-label usage and rapid penetration into adjuvant colon cancer with implications in other off-label indications. Regulatory filing would be anticipated in the first-half of 2008, with approval by late 2008 or early 2009.
Chao upgraded Genentech to "buy" from "hold." In Monday morning trading, shares of the company rose 1%, or 76 cents, to $77.73.
Source: Forbes online
Thursday, May 24, 2007
La Jolla Shares Surge on Riquest Data
La Jolla Pharmaceutical Shares Surge on Presentation of Riquent Data
Shares of La Jolla Pharmaceutical Co. surged as the company highlighted positive data from several prior studies of its lupus drug candidate Riquent.
The stock surged $1.02, or 18.7 percent, to $6.49 in midday trading on more than 5 times average daily volume. Shares have traded between $2.77 and $8.68 over the last 52 weeks.
900-milligram doses were increasingly effective in reducing antibodies. The goal of the Phase III clinical study, results of which were first reported in March, was to prevent or delay renal flare in lupus patients with a history of the condition and antibodies to the disease. It involved 101 patients.
Renal (kidney) problems are very common in patients with lupus. Remember that lupus erythematosus is a disease caused by immune complexes. What this means is that the body produces immune complexes whenever there is an antibody response to a soluble antigen (infection that elicits and immune response). Lupus is a immune complex disease that is characterized by the formation of antibodies to DNA. As a normal process of cell turnover, nuclei [DNA] is exposed as newly made cells leave the bone marrow and mature into red blood cells.
These immune complexes are small and tend to be trapped/formed inside tissues and, primarily in the kidney. Renal disease is therefore the most frequently encountered symptom of LE.
Riquent's mechanism of action is to inhibit the production of autoantibodies from immune cells [B plasma cells]. Riquent is an immunomodulating agent that induces tolerance in B cells directed against double-stranded DNA. It does this by cross-linking surface antibodies. Tolerance basically is the cells not reacting to an antigen any further and sometimes the cells actually die. The fewer positive cells that produce autoantibodies then helps slow the progression of the disease.
Shares of La Jolla Pharmaceutical Co. surged as the company highlighted positive data from several prior studies of its lupus drug candidate Riquent.
The stock surged $1.02, or 18.7 percent, to $6.49 in midday trading on more than 5 times average daily volume. Shares have traded between $2.77 and $8.68 over the last 52 weeks.
900-milligram doses were increasingly effective in reducing antibodies. The goal of the Phase III clinical study, results of which were first reported in March, was to prevent or delay renal flare in lupus patients with a history of the condition and antibodies to the disease. It involved 101 patients.
Renal (kidney) problems are very common in patients with lupus. Remember that lupus erythematosus is a disease caused by immune complexes. What this means is that the body produces immune complexes whenever there is an antibody response to a soluble antigen (infection that elicits and immune response). Lupus is a immune complex disease that is characterized by the formation of antibodies to DNA. As a normal process of cell turnover, nuclei [DNA] is exposed as newly made cells leave the bone marrow and mature into red blood cells.
These immune complexes are small and tend to be trapped/formed inside tissues and, primarily in the kidney. Renal disease is therefore the most frequently encountered symptom of LE.
Riquent's mechanism of action is to inhibit the production of autoantibodies from immune cells [B plasma cells]. Riquent is an immunomodulating agent that induces tolerance in B cells directed against double-stranded DNA. It does this by cross-linking surface antibodies. Tolerance basically is the cells not reacting to an antigen any further and sometimes the cells actually die. The fewer positive cells that produce autoantibodies then helps slow the progression of the disease.
Thursday, May 17, 2007
DUSA Revisited: Shares Jump today:
A Continuation from post 4/29/07: Today;
DUSA Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Levulan® (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the treatment of esophageal dysplasia. This disease occurs in some patients with Barrett's esophagus, a leading cause of esophageal cancer. The incidence of esophageal cancer is one of the most rapidly growing in the U.S., with more than 11,000 new diagnoses each year. Patients diagnosed with high grade dysplasia are at high risk for developing esophageal cancer and currently have limited treatment options.
Note that this is not a current indication from the FDA warning letter described on 29 April. Not even a skin lesion. Barrett's is a direct link to smoking, so this is big time news. More on how the mechanism of photoactivity treatment of dysplasia soon.
DUSA Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Levulan® (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the treatment of esophageal dysplasia. This disease occurs in some patients with Barrett's esophagus, a leading cause of esophageal cancer. The incidence of esophageal cancer is one of the most rapidly growing in the U.S., with more than 11,000 new diagnoses each year. Patients diagnosed with high grade dysplasia are at high risk for developing esophageal cancer and currently have limited treatment options.
Note that this is not a current indication from the FDA warning letter described on 29 April. Not even a skin lesion. Barrett's is a direct link to smoking, so this is big time news. More on how the mechanism of photoactivity treatment of dysplasia soon.
Wednesday, May 16, 2007
The Roller Coaster Ride Continues: DNDN
DNDN is up today (or this hour) ~40 cents a share in early afternoon trading. What's driving the volatility?
They are still trying to figure out exactly what the FDA really wants. More basic data is one thing, but additional clinical trial data and larger cohorts of patients is another.
One also has to realize that the patients in those clinical trials are at the last stages of the disease and are looking for something experimental to prolong life if not for a few days, or weeks.
The real benefit of the drug, in my opinion, would be to determine if the therapy is efficacious in newly diagnosed patients or people that have yet to present the later stages of disease. Using the treatments in combination with standard therapies is also being addressed.
DNDN is trading at $6.06 a share (up 6.5%) with roughly average volume.
They are still trying to figure out exactly what the FDA really wants. More basic data is one thing, but additional clinical trial data and larger cohorts of patients is another.
One also has to realize that the patients in those clinical trials are at the last stages of the disease and are looking for something experimental to prolong life if not for a few days, or weeks.
The real benefit of the drug, in my opinion, would be to determine if the therapy is efficacious in newly diagnosed patients or people that have yet to present the later stages of disease. Using the treatments in combination with standard therapies is also being addressed.
DNDN is trading at $6.06 a share (up 6.5%) with roughly average volume.
Subscribe to:
Posts (Atom)
