Monday, February 26, 2007

Samaritan to Distribute Shire Drug

Monday February 26.

Samaritan Pharma Will Distribute Shire's Hunter's Disease Drug Elaprase in Greece and Cyprus

LAS VEGAS (AP) -- Samaritan Pharmaceuticals Inc. said Monday it signed a marketing agreement with Shire plc to sell Shire's Elaprase to treat Hunter's disease in Greece and Cyprus.
Samaritan will sell the drug on a "named patient" basis until Greece and Cyprus establish pricing and reimbursement for the drug. The drug is expected to launch in the two countries during the second quarter.

Hunter's disease is a hereditary disorder characterized by dwarfism, mental retardation and deafness. It first appears early in life in children and primarily affects males. Most patients die before age 20, Samaritan said.

Shares of Samaritan added 2 cents, or 8.3 percent, to 26 cents on the American Stock Exchange in morning trading. The stock has ranged from 17 cents to 90.5 cents over the past year.

American depository shares of U.K.-based Shire rose 79 cents to $67.40 on the Nasdaq Stock Market in morning trading. Earlier, shares traded as high as $67.73, eclipsing a previous 52-week high of $67.24.

ABOUT Elaprase:
Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II), is a rare, life threatening, genetic disorder with no available treatment. Individuals with Hunter syndrome lack the enzyme iduronate-2-sulfatase, which is essential in the continuous process of replacing and breaking down glycosaminoglycans (GAG). As a result, GAG remains stored in cells in the body causing progressive damage. The symptoms of Hunter syndrome are usually not visible at birth, but usually start to become noticeable after the first or second year of life. Often the first symptoms may include hernias, frequent ear infections, runny noses, reduced growth rate and abnormal facial appearance.

As the disease progresses, a variety of symptoms appear including enlarged liver and spleen, heart failure, decreased endurance, obstructive and restrictive airway disease, sleep apnea, joint stiffness, and, in some cases, central nervous system involvement. If central nervous system involvement exists, the life expectancy for patients with Hunter syndrome is typically 10-15 years of age, however, some patients can survive into the fifth or sixth decade of life. There is currently no effective therapy for Hunter syndrome.

Elaprase is a human iduronate-2-sulfatase produced by genetic engineering technology, developed to replace the missing enzyme in Hunter syndrome patients. Elaprase has been designated an orphan drug in both the United States and in the European Union.

Sunday, February 25, 2007

Gilead HIV Drug Passes Midstage Study

Gilead Sciences Developing HIV Treatment Meets Its Goal in Phase II Clinical Trial

FOSTER CITY, Calif.-- Biopharmaceutical company Gilead Sciences Inc. said its developing HIV treatment GS-9137 met its goal in a midstage study.
The drug candidate is an integrase inhibitor that aims to interfere with HIV replication by blocking the virus from integrating into cells. The Phase II clinical trial involved the drug candidate in combination with ritonavir and a background antiretroviral program. The study's goal was to at least be as effective as the comparison treatment.

The study involved 50-milligram and 125-milligram doses. The 20-milligram dose was discontinued early on in the study because of a high rate of virologic failure.

Shares of Gilead closed down 43 cents to $73.63 on the Nasdaq Stock Market.

Friday, February 23, 2007

Acorda Therapeutics, Cerus Shares Advance; PDL slips again

Acorda Therapeutics shares rose Friday after hedge fund Third Point LLC said late Thursday it has filed a Schedule 13D with the Securities and Exchange Commission, urging the board of Acorda to initiate a process to sell the company. Entities advised Third Point hold 9.9% of Acorda's shares. In a letter to Acorda Chief Executive Ron Cohen, Third Point said "should the board of directors not be responsive to our request, we will explore alternatives for exerting greater control of the company."

PDL BioPharma is still moving lower more than a day after the company missed fourth-quarter earnings targets. The stock was losing 26 cents, or 1.3%, to $19.45.

On the other hand, Cerus was one of the best performers of Friday's session. After the previous close, the biotech company swung to a fourth-quarter profit that easily beat Wall Street's estimates. Cerus was recently up 33 cents, or 5.8%, to $6.07.

Just some stocks I'm watching today. Cerus just had an approval in Germany, so I may jump in soon.

GTX releases positive data for prostate cancer therapy

Biotech group GTX Inc. said early Friday that data from a late-stage clinical trial for its proposed treatment Acapodene show the drug can mitigate two serious side effects associated with the prostate cancer therapy ADT.

GTX said the results were from interim analyses of an ongoing Phase III clinical study of 1,400 men with advanced prostate cancer who were on androgen deprivation therapy, or ADT, a drug combination used to keep prostate cancer tumors in remission. Patients on ADT generally stay on the therapy, which blocks the production of testosterone, for life.

However, one common side effect of ADT therapy is a decrease in bone density, which can lead to bone fractures. Another side effect can be an increase of certain fats in the blood, such as cholesterol and triglycerides, which can lead to cardiovascular disease and even diabetes.
The Phase III data unveiled Friday showed that Acapodene, also known as toremifene, was effective in both increasing bone density and improving levels of cholesterol and triglycerides.

"In previous studies, other agents -- including bisphosphonates -- have also been associated with significant improvements in bone mineral density in men receiving androgen deprivation therapy for prostate cancer," said Dr. Matthew Smith, an oncologist at the Massachusetts General Hospital Cancer Center who authored Friday's presentation, in a statement. See more health-care coverage.

"However, these results suggest that toremifene has the potential not only to reduce the risk of fractures in men with advanced prostate cancer, but also to improve lipid levels, addressing another significant side effect of the standard treatment for this disease," Smith added.
Examples of bisphosphonate drugs include Merck's Fosamax, Novartis' Zometa, Roche's Boniva, and Procter & Gamble and Sanofi-Aventis' Actonel, according to WedMD.
Smith presented the results at the American Society for Clinical Oncology's annual prostate cancer symposium, currently being held in Orlando, Fla.

In an interview with MarketWatch, Smith said the results indicate Acapodene could improve the long-term health and quality of life of ADT patients by making them less prone to bone fractures and cardiovascular disease as they age. He noted that because ADT blocks the production of testosterone, which feeds prostate cancer tumors, men often quickly become obese, a condition that predisposes them to diabetes.
Currently, there are about 1 million men on ADT therapy, with an additional 100,000 put on it every year, according to analysts.

Hopes grow for swing to profitability

GTX Chief Executive Officer Dr. Mitchell Steiner told MarketWatch the company hopes to have final results from the study during the fourth quarter of 2007 or early 2008. It was "shooting for" filing for U.S. regulatory approval during the first half of 2008, he said.

GTX is pursuing having Acapodene approved for the prevention of osteoporosis and other side effects in ADT patients.
The company is also conducting Phase III trials for the drug in the prevention of prostate cancer in men who already have precancerous lesions. Final results from the trials are expected during the first quarter of 2008. Steiner said if the results are positive, the company would file for U.S. approval for that indication in the latter half of 2008.
In a recent note, Cowen & Co. analysts said that each indication represents a potential sales opportunity in excess of $500 million.

Founded in 1997, GTX has yet to turn a profit. However, Steiner said that approval for Acapodene for either indication "would put us on solid footing to profitability."
GTX already markets toremifene under the brand name Fareston for the treatment of advanced breast cancer. According to a note by analysts at Leerink Swan & Co., the patent on toremifene for use in breast cancer is slated to run out in 2009. However, the patents for use in the prevention of prostate cancer and with ADT do not expire until 2019 and 2023, respectively.

he company is also developing a drug called Ostarine to treat the muscle wasting associated with kidney disease and cancer. The drug is currently in Phase II clinical trials.

GTX is up 3 cents per share at $20.80 in light trading this afternoon.

Thursday, February 22, 2007

Biotech, pharma benchmarks move lower

The biotech and pharmaceutical benchmarks moved lower Thursday as shares of Genentech dipped on news that a study has found its oncology drug Avastin can be just as effective in treating lung cancer when used in lower doses.
The DJ Wilshire Pharmaceutical Index closed down 0.3% at 2386.32 and the DJ Wilshire Biotechnology Index eased 0.6% to close at 3219.42.

Shares of Genentech finished down 3% at $85.51.
Early Tuesday, Genentech's parent company, Swiss conglomerate Roche, said a company-sponsored study showed Avastin was effective in treating lung cancer when given in doses at about half of those currently prescribed.

According to DJ Newswires, the study could mean that doctors would be able to prescribe less of the drug, thereby dropping the monthly cost for treatment from $8,800 to $4,400.
Shares of Merck & Co. slipped almost 2% to $43.20 following reports that the company made a $5,000 campaign contribution to Texas Gov. Rick Perry, who later signed a controversial executive order mandating that Merck's HPV vaccine to prevent cervical cancer be given to all Texas girls entering the sixth grade.
A bill to override the executive order is currently making its way through the Texas state House. Earlier this week, Merck announced it was ceasing state lobbying efforts for the vaccine.

Shares of Hollis-Eden Pharmaceuticals rose 1% to $5.56 after hitting a session high of $5.79. The biotech group said it presented positive pre-clinical data for its compound HE3235 for the treatment of prostate and breast cancer. The data was presented in conjunction with the American Society for Clinical Oncology's Prostate Cancer Symposium.
Dyax Corp.shares plunged for the second day, tumbling 14% to close at $3.65. Earlier this week, Dyax said that it had agreed to terminate its collaboration with Genzyme Corp. for its lead drug candidate DX-88, a treatment for the rare disorder hereditary angioedema.

Genzyme shares slipped 1% to $63.99.

GTX Inc to release phase III clinical data Friday Morning

GTx, Inc. (Nasdaq: GTXI), today announced that Phase III data from a bone mineral density interim analysis and from a lipid interim analysis will be presented in separate podium sessions on February 23rd at the American Society of Clinical Oncology Prostate Cancer Symposium. Both analyses were conducted in the first 197 men to complete one year of treatment in the Phase III clinical trial evaluating ACAPODENE® (toremifene citrate) 80 mg for the treatment of multiple serious side effects of androgen deprivation therapy (ADT) for advanced prostate cancer.

Dr. S. Bruce Malkowicz, Professor of Urology at the University of Pennsylvania School of Medicine, will present the bone mineral density interim data, and Dr. Matthew Smith, Associate Professor at Massachusetts General Hospital Cancer Center, will present the lipid interim data. The presentations will be delivered in an Oral Abstract Session beginning at 1 p.m. on February 23rd in the Osceola Ballroom at the Gaylord Palms Resort & Conference Center in Orlando, Florida.

GTx has been notified that these presentations have been selected to be part of an ASCO press briefing the morning of February 23rd.

GTx is conducting the Phase III ADT clinical trial in approximately 1,400 patients at nearly 150 clinical sites in the United States and Mexico. The primary endpoint of the pivotal Phase III ADT clinical trial is a reduction in vertebral morphometric fractures. Secondary endpoints include improvements in BMD, hot flashes, gynecomastia, and lipid profiles. The last patient will complete the trial at the end of November, 2007. GTx will then evaluate the data and prepare it for public release. If the data demonstrate a significant fracture benefit, GTx will file a new drug application in 2008.

I'm keeping an eye out on this stock, and will post what data I can find that could allude to positive or negative results.

GTXI is unchanged in today's trading at $20.55 per share.

Genentech shares tumble on cancer drug news

Biotech company reveals that a lower dose of its drug Avastin worked just as well as a more expensive higher dose, raising revenue concerns.


-- Biotechnology company Genentech said on Thursday that a low dose of its cancer drug Avastin worked just as well as a more expensive high dose in a clinical trial of patients with lung cancer.

Genentech's shares fell nearly 3 percent amid concern the company, as well as its majority owner, Roche Holding (Charts), will receive less revenue from the drug if doctors choose the low-dose version.

"The risk and concern that investors have is that the similar findings from the two dose arms, and the still undisclosed adverse event rates from the two arms, may result in dose and effectively price reductions for Avastin," Geoffrey Porges, an analyst at Sanford Bernstein, said in a research report.

Participation certificates in Roche, its most widely traded form of equity, fell 1.7 percent to 224.20 Swiss francs.

Results from a late-stage clinical trial showed that both 7.5 mg/kg and 15 mg/kg doses of Avastin significantly lengthened the time patients with advanced non-small cell lung cancer (NSCLC) lived without the disease progressing significantly when compared with chemotherapy alone.

"This means that future prescribing is likely to be done with the low dose of Avastin instead of the high dose," said bank Vontobel analyst Karl-Heinz Koch. "The impact is that the monthly price for Avastin in non-small cell lung cancer drops to $4,400 from $8,800."

Analysts expect full data to be presented in May.

Avastin is one of a new family of drugs that work by starving tumors of their blood supply.

Roche and Genentech are banking on increased sales of Avastin to fuel future growth and are testing the drug in multiple different types of cancer.

U.S. sales of Avastin, which is approved for colon cancer and NSCLC and is being studied for a range of solid tumors, were $1.13 billion last year.

Shares of Genentech (down $2.64 to $85.10, Charts) fell 3 percent in midday trading on the New York Stock Exchange.

Wednesday, February 14, 2007

Aastrom Biosciences Study Bone Regeneration With Stem Cell Therapy

Study Indicates Stem Cells help bone grow:

-- Aastrom Biosciences Inc., a developer of stem cell therapies, said Wednesday follow-up data on an early-to-midstage study indicated its tissue repair cells may help bone regeneration.
The 12-month follow-up showed that 18 of the 20 patients involved with severe long bone fractures had multiple bone bridges, which is a sign of bone regeneration. In all, 36 patients are involved in the follow-up, but only 20 have completed the 12-month period.

The patients all had fractures in either their tibia, femur or humerus bones which failed to heal with standard bone grafting and surgical treatments. [Thats a BIG stipulation for the trial AND the N is very small]

Shares of Aastrom rose 5 cents, or 3.5 percent, to $1.49 in morning trading on the Nasdaq.

The simple injection of autologous stem cells is correct in theory, but I'm skeptical of promising complete regeneration of a particular tissue. More research needs to be done on stem cells without the government butting in.

ASTM closed today's trading at $1.50 per share or up 6 cents. In after hours, trading down a penny.

Stem Cells: It Ain't that Easy! Read on.

Osiris Therapeutics, Inc. announced six-month interim results in its evaluation of CHONDROGEN for the regeneration of meniscus in the knee. A total of 55 patients were treated in the Phase I/II, double-blind study evaluating the safety and exploratory effectiveness of CHONDROGEN, a preparation of adult stem cells formulated for direct injection into the knee. At the six month time point, CHONDROGEN met its primary endpoint, demonstrating product safety. The trial did not demonstrate that CHONDROGEN resulted in a statistically significant increase in the volume of meniscus as compared to placebo; however, an improvement in baseline cartilage and joint condition was noted in patients treated with the stem cell drug that was not seen in patients that received placebo. An interim review of the data will be presented by C. Thomas Vangsness Jr., M.D. at the Stem Cell Summit in San Diego on February 13, 2007.

The study was designed to assess the safety of an injection of stem cells into the joint capsule and to gain preliminary efficacy data on the extent of tissue regeneration using magnetic resonance imaging or MRI. Patients in the study underwent standard meniscectomy surgery to remove torn or damaged tissue in their meniscus. One week following surgery, the patients were given a single injection of either placebo, or a low dose (50 million cells) or high dose (150 million cells) of CHONDROGEN. Neither the patients nor the surgeons will know what was given for the duration of the study. Patients will be followed for safety and additional preliminary efficacy, such as pain, cartilage damage, and changes in the meniscus for two years under the current study protocol.

An initial review of the data showed that CHONDROGEN was well tolerated, was not associated with serious adverse events, did not result in any adverse hematological events, and did not result in the formation of any unwanted or ectopic tissue. There was no significant change in the volume of meniscus on MRI at 6 months in patients that received CHONDROGEN compared to those patients receiving placebo. However, about 30% of patients treated with CHONDROGEN demonstrated an improvement in their baseline cartilage or joint condition, while no patients in the placebo group demonstrated similar improvement.

"Although we are very pleased to see that our stem cells continue to be well tolerated, we are obviously disappointed that we were unable to detect significant amounts of meniscal regeneration," said C. Randal Mills, Ph.D., President and CEO of Osiris Therapeutics. "Presently, we are working to complete our review and fully evaluate the entirety of the data we have received. Moving forward, we await the cartilage data from the one year time point and will investigate further the improvements observed in the pre-existing cartilage damage."

NASDAQ:OSIR ended today's trading unchanged at 18.45 per share. The stock has been heading down since around Feb 8. This data is a PERFECT example of the misconception of stem cell research vs. what the media [MJ Fox for example] would lead you to believe.

Monday, February 12, 2007

Achillion sinks on Hep C trial halt

Achillion Pharmaceuticals Inc. shares lost more than half their value Friday, after the company and its partner Gilead Sciences Inc. decided to abandon their hepatitis C drug.

Gilead and Achillion said Thursday preliminary trial results of the drug had shown an increase in the level of serum creatinine, which indicates abnormal kidney function.

Shares of New Haven, Conn.-based Achillion closed down $9.12, or 51 percent, at $8.87 on the Nasdaq Stock Market. The shares traded as low as $8.56, below the previous 52-week low of $11.57 hit Oct. 27. Shares were trading at a year high of $20 on Feb. 1.

Shares of Foster City, Calif.-based Gilead closed down $1, or 1.4 percent, at $71.16 on Nasdaq.

The companies said they are continuing their partnership and will be back underway in the first half of 2008 in testing with other similar compounds.

Needham & Co. analyst George Fulop said Gilead and Achillion are now "a couple of years behind."

Adam Cutler, an analyst with JMP Securities, said there's "a silver lining as the drug has a totally novel mechanism," and called the share movement an "overreaction."

However, analysts say moving toward a new combination treatment, or a "cocktail," as is used against HIV, is showing the greatest potential to treat the hepatitis virus, and is the most likely outcome. The hepatitis C virus mutates and can easily become resistant to drugs.

Hepatitis C, an infection passed through the blood, often by sharing needles or through blood transfusions is the main reason for liver transplants in the U.S. About 170 million people worldwide and more than 3 million Americans are infected.

Wall Street has been betting on a drug from Vertex Pharmaceuticals Inc., which has shown promising results with little side effects so far. Analysts are waiting for results from three large studies in the U.S. and Europe in the first half of 2007, which together involve 1,000 patients. The company has said it expects to file an application for approval of the drug in the United States in the second half of 2008.

Vertex shares closed Friday at $32.36, down 67 cents, or 2 percent, on the Nasdaq.
ACHN is trading at $8.89 today.

The halted experimental drug was an anti-HCV mechanism that involved inhibition of a viral protein called NS4A, which binds to a portion of HCV protease.
A common feature of positive-strand animal RNA viruses involves the synthesis of polyproteins which are co- and post-
translationally cleaved to produce essential viral components of the RNA replication machinery and structural proteins for
virion assembly. Such cleavages are usually catalyzed by one or more viral proteinases and, in some cases, host enzymes. This strategy is shared by the hepatitis C viruses (HCV), a group of enveloped, positive-strand RNA viruses. NS4A is a cleavage product of the virus.

Stem Cell Summit to Be Held in San Diego; Cytori and Orthofix Intl. Slated to Present

Executives from Cytori Therapeutics Inc., Orthofix International NV, Viacell Inc., Geron Corp., Osiris Therapeutics Inc. are among those slated to present at the second annual "Stem Cell Summit," a conference focusing on the commercialization of stem cell products starting Monday in San Diego.

Cytori Therapeutics Chief Executive Chris Calhoun will outline the company's commercialization strategy for its breast reconstruction product and provide an update on the start of a cardiovascular disease clinical trial.

Orthofix International subsidiary Blackstone Medical Inc.'s director of research and education, Raymond J. Linovitz, will give a presentation discussing the potential that adult stem cells provide for the orthopedic industry.

ViaCell Chief Technology Officer Morey Kraus is slated to discuss the company's work using cord blood stem cells in cancer treatment. Jane Lebkowski of Geron Corp. is on the agenda to discuss embryonic stem cell technology and transplants, and Osiris President and Chief Executive C. Randal Mills will discuss their work on orthopedic and cardiovascular uses for stem cell therapies.

Researchers hope they can train human embryonic stem cells to repair damaged organs in need of healthy cells, but the Bush administration has restricted federal funding for embryo work since 2001, leading some scientists to seek alternative sources for stem cells.

States have also stepped in to fill in funding gaps for embryonic stem cell research. New Jersey agreed in December to spend millions of dollars on the research, joining California, Connecticut, Illinois and Maryland in providing state funds in the field. Other states are considering similar moves.

CYTORI THERAPEUTICS (NasdaqGM:CYTX) is trading up today 52 cents to $6.32 per share.
ORTHOFIX INTL NV (NasdaqGS:OFIX) is trading down now, 54 cents per share at 49.46.

Thursday, February 08, 2007

Part of the reason I made this site:

Like all industries, biotech has its own jargon. Newcomers to the sector can find themselves struggling to get through just one paragraph of a press release without having to look up several terms.
Here is a primer on some of the key phrases, acronyms or statistical concepts that you'll need to know when investigating a biotech stock idea.

ANDA -- Abbreviated New Drug Application. This is an application to the Food and Drug Administration (FDA) to seek approval of a generic drug.

NDA -- New Drug Application. This application seeks approval for a new drug before commercialization. Included in the NDA is safety and efficacy data, proposed labeling and manufacturing methods.

IND -- Investigational New Drug. This is the process in which companies apply to the FDA for permission to begin trials of a new drug in humans. Pharmion announced last week that the FDA accepted the company's IND for an oral version of Vidaza, a treatment for patients with myelodysplastic syndromes. The new drug will enter phase I trials shortly.

It's also important to keep in mind that drugs can be in different phases for different diseases. For example, Genentech's Avastin is approved for colorectal and non-small-cell lung cancer. However, the drug is in or about to begin phase III trials for a host of other cancers, including first-line metastatic breast cancer and first- and second-line ovarian cancers. Avastin is being prepared to enter phase II for extensive small-cell lung cancer.

P-value -- A measure of how statistically significant a trial's results are. In other words, it's the percentage chance that a result is not true. The standard "line in the sand" p-value is 0.05, meaning 5%. Results with a p-value of greater than 0.05 are considered statistically insignificant. The results have a greater than 5% chance of being false.

Monday, February 05, 2007

CEL-SCI Corporation Releases Letter to Shareholders

VIENNA, Va., Feb. 5 -- The following letter is being released by CEL-SCI Corporation to its shareholders:

Dear Fellow Shareholders:

We are elated!!! After announcing last year that the head & neck cancer patients enrolled in our key Phase II clinical trial with our cancer drug Multikine® showed a 33% increase in overall survival 3.5 years after surgery, we now have great news again. In January of 2007 we received the go- ahead from the U.S. Food and Drug Administration (FDA) to commence our Phase III clinical trial with Multikine in patients with advanced primary head & neck cancer. Very few drugs ever make it to Phase III clinical testing. Our success is even more incredible because Multikine is a "first in a new class of anti-cancer drugs".

We can still remember the long list of objections that potential investors threw at us in the past. This list has now become very short. The only remaining objection to our Multikine in some parts of the investment community is the fact that Multikine is an immunotherapy treatment. Immunotherapy, while ultimately expected to be very successful in the treatment of cancer, has not been successful in studies conducted by other companies so far. When we mentioned this issue to an oncologist friend of ours he responded, "But that should not be an issue for Multikine because you have the data to show that your drug works." He is right, but we still have to go out of our way to explain why Multikine works when other immunotherapy drugs have not delivered the expected results.


1) As you know our cancer drug Multikine is a defined and consistent
mixture of human cytokines, substances that coordinate an immune
response. Cytokines as a therapy have been very successful when used in
a situation where there is a clear and simple cause and effect
relationship, such as in the case of Amgen's multi-billion dollar drug,
EPO. If you need more red blood cells, you take EPO and the problem is
"fixed". However, in the treatment of cancer using the single cytokine
approach has not worked well because there is no single cause and
effect. You need a comprehensive anti-tumor immune response to be
successful in the fight against cancer. Our Multikine, as we have
published in the "Journal of Clinical Oncology", empowers the patient's
own immune system to mount a comprehensive and effective anti-tumor
immune response.

2) Historical cancer drug development placed the emphasis on developing
drugs for patients who have failed prior therapy. This same thought
pattern was extended to immunotherapy and immunotherapy was given to
late-stage cancer patients. We now know that this makes no sense -- and
in fact, it is starting to make no sense to many oncologists with whom
we have consulted. Why would one want to try to stimulate the immune
system after it has been ravaged by surgery, radiation and
chemotherapy? There is not much left to be stimulated. We give our
Multikine to cancer patients with advanced tumors that have not yet
been treated because they still have an immune system that can be
stimulated and is able to respond!

3) You may be the best at your job, but you will most likely fail if you
are tasked with everybody else's job which you know little to nothing
about. That is what was requested of immunotherapy by others until now.
It has been asked to clean up the "mess" of all prior failed cancer
therapies pretty much on its own. No wonder it did not succeed!

We give our Multikine to cancer patients in supra-physiological doses, the way the body does, we give it to patients who have not yet been treated and still have an intact immune system that can be stimulated, and we give it as an adjunct (enhancement) to the existing first-line cancer therapy for advanced primary head & neck cancer patients.

The primary goal of Multikine is to "clean" the tumor margins and to kill the tumor cells that have migrated to the local lymph nodes. This is crucial because the tumor cells around the tumor and those in the local lymph nodes are the primary reason for recurrence in these patients. By eliminating these tumor cells, we can reduce recurrence of the tumor and hopefully increase the overall survival of these patients in a meaningful way.

Multikine does other things as well. All of them can be viewed as wonderful additional bonuses. Multikine has been shown to be non-toxic, eliminate the tumor in 12% of the patients after only a 3 week treatment, on average reduce the number of tumor cells by about 50% before the scheduled surgery even begins, and enhance the likely effectiveness of the radiation/chemotherapy treatment given after surgery (Laryngoscope. 2003 Dec; 113(12): 2206-17).
Now that we have FDA go-ahead for our Phase III study with Multikine, we have a clear path to approval. We were told that we will only need one clinical trial, as long as the data is robust enough. The Phase III study essentially is a comparison between the current standard of care for advanced primary head & neck cancer patients (surgery plus radiation or concurrent radiation and chemotherapy) on the one hand and our Multikine for 3 weeks prior to the standard of care on the other hand. This global study will enroll about 800 patients. To be successful, the group of patients receiving Multikine plus the standard of care treatment will need to show a 10% increase in overall survival when compared to the group of patients receiving standard of care treatment alone.

(Amex: CVM---closed Friday's trading at 81 cents a share. Today's letter saw a slight increase in stock price, up 4 cents to 85 cents a share. Clearly, investors are not impressed by the data, IMO wrongly, that immunotherapies don't work, when indeed they do. I will watch this stock and I think my in may be at 95 cents a share.

Iranian Herbal AIDS Medicine Introduced

TEHRAN (AFP) - Health Minister Kamran Baqeri Lankarani has announced that Iran's scientists have produced a herbal medicine that boosts the human's body immunity system against the HIV/AIDS virus.


"The herbal-based medication, called IMOD, serves to control the AIDS virus and increases the body's immunity," Baqeri Lankarani was quoted as saying by the official news agency IRNA.

"It is not a medication to kill the virus, it rather can be used besides other anti-retroviral drugs," Baqeri Lankarani said on state radio.

The drug, made after five years of research, has been tested on 200 patients, IRNA said, adding that it is considered the fifth generation of medications helping control the HIV/AIDS virus.

"This is a substance good for both AIDS patients and those who carry the virus without showing the symptoms," the director of the project, Mohammad Farhadi, told state television.

Farhadi said the medication will now be tested on some 3,000 to 5,000 Iranian patients in the next year to monitor its efficacy.

Health Minister Baqeri Lankarani said that the number of HIV/AIDS cases in Iran stands at around 14,000 while 1,700 people have died of the disease.

Last June, Iranian officials warned about the rapid spread of HIV/AIDS infections in the country due to a surge in intravenous drug usage.

"If no action is taken against the spread of this disease as quickly as possible, the number of those infected will reach 100,000 by the end of the next Iranian year (March 2008)," said Iran's deputy health minister, Moayed Alavian.

Iran is believed to have at least two million regular drug users -- and possibly as many as 3.5 million. Alavian said addiction is growing by around eight percent a year.

Intravenous drug use is believed to be the main cause of HIV/AIDS infection at 62.3 percent, followed by "unknown causes" at 27.9 percent and sexual contact at 7.4 percent.

Wouldn't this be more believable if not just a press release but accompanied by a scientific report or a peer reviewed journal article that is published? I really have my doubts on the validity.

Friday, February 02, 2007

HIV Microbicide trials stopped; Polydex stock loses 50% of value

Shares in Polydex Pharmaceuticals Ltd. lost more than half their value on news that two phase III trials of its HIV prevention product have been halted.

The product, called Ushercell, is a cellulose sulfate-based vaginal microbicide being developed to prevent the virus from infected women. But a reproductive health research organization called the Program for Contraceptive Research and Development (CONRAD), which is conducting one of the studies, halted it because preliminary results at some trial sites indicated that cellulose sulfate instead could lead to potential increased risk of HIV infecttion in women who use the topical gel.

Specifically, there was a higher seroconversion rate in those who received the investigational product than in placebo patients. Despite the discrepancy between findings at various sites, it remains too early to speculate whether any environmental or other factors contributed to the higher risk, says Linda Hughes who heads the investor relations for Toronto based Polydex.

POLXF closed today's trading up 10 cents to $2.80. POLXF hit a 52 week high of $10.50 last spring.