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Neopharm Stock Slumps; Cancer Drug Falls Short Of Hopes

Neopharm Inc. shares slumped 75%, to a 52-week low, after the company announced that its experimental drug for brain cancer didn't perform statistically better in a clinical trial than an existing drug.

The stock was trading recently at $1.73, off $4.99 from Friday's close at $6.72. Earlier, the shares fell to $1.68, off $5.04 from Friday's close and surpassing a previous 52-week low of $4.32 set in July.

Volume was 10.4 million shares traded, compared with a daily average of 426,000.

Analysts called the sell-off warranted.

"It's a very fair reaction," said Brean Murray Carret & Co. analyst Jonathan Aschoff, who noted that he had a sell rating on Neopharm shares prior to Monday's development.

Aschoff said he thinks shares of Neopharm, a Waukegan, Ill., pharmaceutical company, are worth "a couple bucks," or a slight premium to the company's cash.

Neopharm's drug - cintredekin besudotox - "did not beat the control" in the study, Aschoff said. "It was slightly better, but no where near statistically so."

ThinkEquity Partners analyst Vinny Jindal said it's unclear what the company will do now.

Jindal described the investor reaction as "largely justified," and he said he plans to listen closely to a Neopharm conference call that's been scheduled for after Monday's market close to see "how (company executives) plan to put Humpty Dumpty back together again."

Drug Pipeline Series: Submissions, Dec 4 - Dec 11, 2006

Theravance, Inc. announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for telavancin, a rapidly bactericidal injectable antibiotic with a unique multifunctional mechanism of action, for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria.

Eli Lilly and Company announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration's Division of Drug Oncology Products (DDOP) for EVISTA® (raloxifene HCl) for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer. EVISTA is currently indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Drug Pipeline Series: Phase III, Dec 4 - Dec 11, 2006

Isotechnika Inc. announced that the Company has enrolled its first patient in a pivotal Phase III European/Canadian clinical trial for the treatment of moderate to severe psoriasis with its lead immunosuppressive drug, ISA247.

Vanda Pharmaceuticals Inc. announced positive top-line results from the company's Phase III clinical trial evaluating iloperidone, an atypical antipsychotic, in patients with schizophrenia.

Drug Pipeline Series: Phase II, Dec 4 - Dec 11, 2006

Helix BioPharma Corp. announced that it has initiated patient enrollment in a Phase II clinical trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts (condylomata accuminata) associated with human papilloma virus ("HPV") infection. The trial, which is taking place in Sweden, will assess the efficacy and safety of Topical Interferon Alpha-2b compared with placebo using a double blind, randomized design over an examination period of four months per patient.

Immtech Pharmaceuticals, Inc. announced that it has initiated a Phase II trial in the U.S. of its oral drug candidate, pafuramidine maleate, as a prophylaxis to prevent malaria infections for travelers to endemic regions. This study protocol was reviewed by the U.S. Food & Drug Administration and has been approved by the Institutional Review Board of a major U.S. medial center. It is estimated that each year 125 million travelers go to countries where malaria is endemic.

MethylGene Inc. , along with its partner Pharmion Corporation announced the initiation of a Phase II clinical trial with its isotype-specific histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, in patients with high-risk myelodysplastic syndromes (MDS) or relapsed or refractory acute myelogenous leukemia (AML). Specific patient populations include elderly patients who have previously untreated disease or adult patients who have relapsed or refractory disease.

Cleveland BioLabs has begun a Phase II efficacy study of Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer.
Curaxin CBLC102 is an oral drug used in the past to treat malaria that demonstrates efficacy in vitro, in animal models and in live tumors removed from patients. Initial test results indicate that CBLC102 can be effective against a number of malignancies, including hormone refractory prostate cancer, renal-cell carcinoma and soft-tissue sarcoma.

Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth and Lundbeck A/S presented clinical study results for bifeprunox at a major medical conference this week. Bifeprunox is an investigational treatment for schizophrenia studied as a once-daily regimen. Results of these efficacy and safety studies showed that, in a six-month trial, bifeprunox maintained stability in patients with stable schizophrenia versus placebo.

EPIX Pharmaceuticals, Inc. announced the initiation of a Phase 2a clinical trial to further evaluate PRX-03140 as monotherapy and in combination with donepezil for the treatment of Alzheimer's disease. This Phase 2a trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once-daily for 14 days in patients with mild Alzheimer's disease who are on a stable dose of donepezil (10 mg). Data from this trial are expected in the second half of 2007.

Inspire Pharmaceuticals, Inc. announced the initiation of a Phase 2 clinical trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis.
This Phase 2 clinical trial is a 14-day randomized, double-blind comparison of two doses of epinastine nasal spray (0.05% and 0.1%) to placebo in approximately 580 subjects who have a documented history of seasonal allergic rhinitis to mountain cedar pollen.

Drug Pipeline Series, Phase I, 4 Dec - 11 Dec, 2006

Nastech Announces Positive Phase 1 Clinical Results of Insulin Nasal Spray Compared to Exubera® Inhalation Powder and NovoLog(C) Insulin Aspart Injection.

Vernalis plc announced that it has started a Phase I trial of V24343, a CB1 antagonist, as a potential treatment for obesity, type II diabetes and related disorders.

Neose Technologies Presents Positive NE-180 Phase I Clinical Trial Data at American Society of Hematology Annual Meeting, a Novel GlycoPEGylated™ Erythropoietin, Demonstrates Dose-Dependent Activity in a Phase 1, Single Dose, Dose Escalation Study in Normal Human Volunteers". NE-180 is being developed for the treatment of anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

OMRIX Biopharmaceuticals Commences Phase 1 Clinical Trial for Fibrin Patch product for the management and rapid control of bleeding including severe bleeding in surgery.

ArQule, Inc. announced the enrollment and successful dosing of the first patient in a Phase 1 clinical trial with ARQ 171, a second-generation compound generated through its Activated Checkpoint Therapy(SM) (ACT) program. Phase 1 data from this compound, together with Phase 2 data from the ongoing ARQ 501 program, will form the basis of a future licensing decision by Hoffmann-La Roche (Roche).

Merck & Co., Inc. and Vertex Pharmaceuticals Incorporated announced results of a Phase I clinical trial for MK-0457 (also known as VX-680), an investigational small molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases. The study, conducted at The University of Texas M. D. Anderson Cancer Center and Duke University Medical Center, showed that MK-0457 demonstrated clinical activity in select patients with chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) with the T315I BCR- ABL mutation and also in patients with refractory JAK-2 positive myeloproliferative diseases (MPD).

Novacea, Inc. announced that Phase 1 data of AQ4N (banoxantrone), an investigational anti-cancer prodrug, demonstrated that AQ4N was active and well tolerated when administered to patients with non-Hodgkin's, chronic lymphocytic and Hodgkin's lymphomas.

Dynavax Technologies Corporation announced the initiation of a Phase 1 dose escalation clinical trial of its TLR9 agonist in combination with a standard chemotherapeutic regimen for metastatic colorectal cancer. The enrollment target of the trial is 15 patients, all of whom will have been previously treated for colorectal cancer but had a recurrence of the disease.

Avigen, Inc. announced findings from a Phase I clinical trial for AV650 (tolperisone), an oral therapy intended for the treatment of disabling neuromuscular spasticity and spasm. AV650, a New Chemical Entity (NCE) in the U.S., was found to be well tolerated with no evidence of sedation in this trial.
The Phase I study enrolled 30 healthy adult volunteers at one center in the U.S.

DURECT Corporation announced that it has successfully completed Phase I clinical trials with a new product, DUR-843, which is intended to treat a persistent pain condition. We believe that the persistent pain market remains underserved and that DUR-843 has the potential to provide several advantages over existing pain medications.

Nuvelo Hit As Drug Fails In Trial

Shares of Nuvelo Inc. (NUVO) plummeted 80% to $3.97 before the opening bell Monday after the company and partner Bayer AG (BAY) said a Phase III clinical trial of its blood clot dissolving drug didn't meet its primary endpoint.

The drug, alfimeprase, used for treatment of thrombotic, or clot-related disorders, didn't meet its primary endpoint of avoidance of open vascular surgery within 30 days of treatment in patients with acute peripheral arterial occlusion, known as "leg attack," the company said Monday.

The companies also suspended enrollment in two other Phase III trials.

"While Nuvelo did not say exactly why the trials failed, we believe that it is safe to assume that there was almost nothing encouraging about the results of the trials," Brean Murray says, adding it expects deal with Bayer to dissolve.

Nuvelo and Bayer HealthCare have a global collaboration for the development of alfimeprase, whereby Bayer would bring it to market outside the U.S. and will pay Nuvelo tiered royalties, and Nuvelo retains marketing rights in the U.S.

American Depositary Shares of Bayer had yet to trade.

Shares of travel-booking company Sabre Holdings Corp. (TSG) rose 11% to $31.30 on news reports that the company is up for sale and could be sold to a new buyer as early as this week, at a premium to its $3.75 billion market capitalization.

Private-equity groups were viewed as the most likely purchasers of Sabre, the reports said. Citing people involved in the negotiations, The New York Times said the bidding group favored to win the auction includes Silver Lake Partners and Texas Pacific Group, while a rival bidding group is led by Apollo Group. The people involved in the talks said a third group of investors is also considering a bid, the Times said.

Shares of Biomet Inc. (BMET) rose 4.8% to $41.80 after a newspaper report said British company Smith & Nephew Ltd.(SN.LN) will this week make a GBP5 billion offer for the company, in an attempt to to create the world's fourth-largest orthopedic implants maker.

Biomet in effect put itself up for sale in April when it appointed Morgan Stanley (MS) to advise on strategic options, The Independent, a U.K. daily, said on its Web site.

Shares of DuPont Co. (DD) rose 0.7% to $47.25, after the company lifted its fourth-quarter outlook. DuPont also said it would close or change manufacturing processes at 10 of its sites and cut about 1,500 jobs worldwide.

DuPont now anticipates 2006 earnings of $3.25 a share, up from a previous outlook of $2.86 a share. The company said it would list additional benefits in the fourth quarter, including about $60 million from insurance payments from asbestos litigation and Hurricane Katrina-related claims and $500 million from tax adjustments.

Analysts polled by Thomson Financial presently forecast 2006 earnings, on average, of $2.88 a share.

Shares of DirectTV Group Inc. (DTV) rose 2.1% in pre-market trading to $24.80, after Deutsche Bank upped its rating on the company to buy, saying the digital television service provider is best positioned to take advantage of high-definition TV and will benefit from becoming part of the Liberty Media Corp. empire.

Shares of Cepheid (CPHD) rose 5.4% to $9.49 after the company received approval from the Food and Drug Administration to market its Smart GBS test for Group B Streptococcus on its SmartCycler platform.

Novartis Drug Tasigna Helps Leukemia Patients

Swiss drugmaker Novartis AG (NVS) said Monday an intermediate stage study showed that its experimental drug Tasigna achieved impressive results in the treatment of blood cancer patients who no longer responded to treatment with its drug Gleevec.

The study showed that 74% of patients in the chronic phase of chronic myeloid leukemia, or CML, a blood cancer, achieved normal white blood cell counts after six months of treatment. Of 279 patients treated, the defective chromosome that causes the disease was significantly reduced in more than half, and was completely eliminated in about a third of these patients.

All these patients had developed resistance to Gleevec, the standard of care for the condition, or didn't tolerate Gleevec.

The study was presented at the American Society of Hematology, or ASH, meeting in Orlando, Florida.

Gleevec, launched five years ago and one of the first of what are known as targeted cancer drugs is Novartis' second-best selling drug with sales of $2.17 billion in 2005. Targeted cancer drugs work by killing cancer cells specifically, or by hindering their proliferation, while traditional chemotherapy often kills deranged and healthy cells alike, leading to troublesome side effects.

Tasigna, known generically as nilotinib, and Gleevec, known generically as imatinib, both work by telling a specific gene to stop producing excessive white blood cells. Tasigna was designed to also work in cases when this gene had mutated. Such mutations can cause resistance to the Gleevec treatment. CML patients usually go through three phases: chronic phase, accelerated phase and blast phase.

In 52% of patients in the chronic phase of CML, the Ph+ chromosome - the genetic abnormality that characterizes most cases of this form of leukemia - was significantly reduced, while in 34% it was undetectable after treatment with Tasigna, Novartis said.

Patients in a more advanced phase of CML also responded to the Tasigna therapy.

Of the 64 patients in the accelerated phase, 59% achieved a normalization of their white blood cell counts, and in 36% the Ph+ chromosome was reduced or eliminated after eight months of treatment.

The study researchers concluded that Tasigna was generally well tolerated. Specifically, the investigators said that the compound wasn't associated with many of the side effects seen with Gleevec, such as fluid retention and superficial edema.

Novartis, based in Basel, Switzerland has recently submitted Tasigna for U.S. and European Union regulatory approval, on the basis of this study. When considering cancer drugs, the regulators sometimes accept earlier phase II studies rather than larger phase III trials that it typically requires most companies to submit with drug-approval applications.

James Shannon, head of drug development at Novartis, said recently that he expects global peak sales of Gleevec and Tasigna combined to exceed $3.5 billion.

David Epstein, who heads Novartis' oncology business told an agency that the company plans to start a trial that directly compares Tasigna to Gleevec in the first half of 2007. Should Tasigna turn out to be more effective, as well as safer, in this trial, it could eventually replace Gleevec as the standard of care for this form of leukemia.

However, both Gleevec and Tasigna will also be competing with Sprycel, or dasatinib, a drug developed by Bristol-Myers Squibb Co. (BMY), which has been launched in both Europe and the U.S. this year.

Tasigna and Sprycel have never been tested against each other, which makes it difficult to compare them, but data so far suggest that the Novartis drug has less unwanted side effects, analysts say.

"Tasigna appears to be at least as effective as Sprycel, but with fewer side effects," said Karl-Heinz Koch, analyst in Zurich at private bank Vontobel, who has a buy rating on Novartis.

Bristol-Myers also presented data at the ASH conference, that are directly comparing Sprycel to a high dose of Gleevec, when given to patients who no longer responded to the standard Gleevec those.

After 15 months of treatment, the defective chromosome that causes CML was significantly reduced in 53% of patients who were given Sprycel, compared to 33% of patients who took the high dose of Gleevec.

"This study may help answer important questions about treating resistant chronic-phase CML patients and suggests that physicians should consider treatment with Sprycel in patients resistant to lower doses of Gleevec," said Neil Shah, an assistant professor at the division of hematology and oncology of the University of California, in a statement.

Still, given that these patients had already developed resistance to the standard dose of Gleevec, it shouldn't come as a huge surprise that Sprycel was shown to work better for these patients, Vontobel's Koch added.

Actelion about To Disclose New Cardiovascular Drug

Swiss pharmaceutical company Actelion Ltd (ATLN.EB) will release details of a new experimental heart drug this month that most analysts say could be either a successor to its flagship drug Tracleer, or a new niche treatment.

Actelion has been tightlipped so far on the compound, dubbed Actelion-1, and has not revealed which specific disease the drug is aimed at. But in a survey of 10 analysts by an agency, five said Actelion-1 would probably be a specialty cardiovascular drug, while two thought it would likely be a follow-up to Tracleer. Three were undecided. Two of the analysts said they thought the compound could also be a diabetes-related drug.

Actelion is heavily dependent on revenue from Tracleer right now, and industry experts say a positive announcement regarding either an improved Tracleer follow-up or a wholly new drug could substantially boost the stock.

"It's either an improved follow-up to Tracleer or an innovative compound in the cardiovascular specialty area," said Birgit Kulhoff, an analyst at Rahn & Bodmer.

Actelion spokesman Roland Haefeli would only say, "We do expect to make a disclosure on Actelion-1 before the end of the year...it's a compound evaluated for cardiovascular diseases in Phase II testing."

Tracleer is used to treat pulmonary arterial hypertension, or PAH. The condition is rare but often fatal and causes arteries in the lungs to become narrow or blocked and blood pressure to rise.

Actelion derived around 95% of the CHF247.2 million (US$206.4 million) in sales it posted during the third quarter from the drug, which was the only available treatment for PAH when it was launched in 2001, though competition is now waiting in the wings.

Encysive Pharmaceuticals Inc.'s (ENCY) Thelin is expected to soon receive final U.S. approval, while Myogen Inc. (MYOG) - recently bought by Gilead Sciences Inc. (GILD) - is expected to file its ambrisentan drug soon.

Given Actelion's current dependence on Tracleer, some analysts said investors could respond more positively if Actelion-1 turns out to be a new specialty cardiovascular drug rather than a new version of Tracleer.

At 1310 GMT Friday, Actelion's shares were up 1.4% at CHF223 in a lower Swiss market.

"Positive results from (a trial on Actelion-1 and another trial on Tracleer) would...likely cause us to boost our target price, perhaps substantially," said Denise Anderson, an analyst at Kepler Equities who has a buy rating on the stock with a CHF255 target price.

Negative results would leave her estimates unchanged, and any dip in the share price would also be a good entry point, she added.

Of those pharmaceutical analysts expecting a Tracleer follow-up, one said it could be a more targeted compound and could therefore potentially be more effective or have a smaller risk of side effects.

"It's likely to be a follow-on compound to Tracleer," he said. "In order to make the secrecy around Actelion-1 economically sensible, the only thing I can come up with is that it's a selective endothelin antagonist."

An endothelin receptor antagonist works by blocking endothelin receptors, with which endothelin - responsible for constricting blood vessels and raising blood pressure - connects in order to be activated.

However, most analysts say they don't expect an updated version of Tracleer and note it's hard to predict with so little information available which heart conditions a cardiovascular drug might target.

"It's not going to be a hypertension drug as Actelion says it plans to market the drug themselves" and marketing a hypertension drug would involve collaboration with another company due to the higher costs involved, said Anderson at Kepler Equities. "And the number of cardiovascular indications that it could be, is huge," she added.

Auxilium Pharma Shares Dn On Disrupted Trial

Auxilium Pharmaceuticals Inc. (AUXL) shares fell 8% Thursday after the company said it has to suspend dosing in a Phase III trial of a drug for the treatment of Dupuytren's contracture, a rare hand deformity, due to a manufacturing issue.

Dupuytren's contracture, which usually occurs in white adults in their 50s and 60s and is currently treated by surgery, can cause the fingers to bend towards the palm, and is caused by a thickening of the skin of the palm.

Late Tuesday, the company said it was temporarily stopping the dosing of patients in its ongoing Phase III trials for its AA4500 drug, and will conduct an investigation into the problems, which it believes are due to a higher-than-expected moisture content within some vials used to store the drug, possibly because of faulty equipment.

Shares of the company were recently changing hands at $14.68, down $1.28, or 8%, with around 1.3 million shares traded, more than three times average daily volume.

Auxilium's drug is unique in that it is a non-surgical approach. Currently there is no cure for the problem, and surgery doesn't prevent a recurrence. Injectable enzymes can break down the knots and cords of the hardened tissue.

The company said during a conference call that it has notified the U.S. Food and Drug Administration before re-starting the clinical trials and expected the FDA to take around 30 days to review the data. Management said it was uncertain whether it would have to create a new batch of drugs for the trials, adding investigators will continue to monitor patients already dosed in the trials.

Piper Jaffray said a delay could push back its launch timeline for late 2008, but may not have an impact on Auxilium's exclusivity for the drug, as Auxilium has orphan-drug protection - which is granted for drugs that treat rare diseases - for seven years in the U.S.

Iloperidone NDA Seen In 4Q 2007

Vanda Pharmaceuticals Inc. (VNDA) said that its antipsychotic drug, iloperidone, performed well in a late-stage clinical trial, adding that a New Drug Application for it likely will be filed with federal regulators late next year.

Separately, Vanda Chief Executive Mihael Polymeropoulos said during a CNBC interview Thursday that various pharmaceutical companies have expressed interest in buying his company because of its pipeline of products.

The dual developments sent shares of Vanda, a Rockville, Md.-based biotech company, soaring to a 52-week high of $28.67 in early trading, up 85% from Wednesday's close and surpassing a previous 52-week high of $17 set Nov. 15.

The shares were trading recently at $26.31, up $10.81, or about 70%. Volume was 5.12 million shares traded, compared to a daily average of 312,000.

Vanda executives said the Phase III clinical trial evaluated iloperidone, an atypical antipsychotic, in patients with schizophrenia. The drug demonstrated statistically significant improvement compared to placebo on the Positive and Negative Symptom Scale, the trial's primary endpoint, they said.

Paolo Baroldi, Vanda's chief medical officer, said in a prepared statement that the successful trial means the company is getting closer to filing a New Drug Application for iloperidone with the Food and Drug Administration, which is expected in late 2007. The company also is "one step closer to making iloperidone available to patients and providers dealing with schizophrenia," Baroldi said.

JP Morgan concurred in a research note, saying the Phase III results are sufficient for the NDA filing expected in late 2007.

Meanwhile, Vanda's Polymeropoulos said during his CNBC interview that no decisions have been made regarding a possible sale of the company, although he said many suitors likely would be interested.

Microbicides Against HIV

Women are increasingly at risk of contracting the HIV virus, and yet the most well-known method to prevent transmission during sexual activity is ultimately a decision made by the man.

But the days where male condoms are the best and easiest solution might be coming to an end as four different forms of microbicides - gels or creams with antivirals women can apply vaginally to prevent HIV (human immunodeficiency virus) infection - are now in final testing phases.

Experts say a total of more than 60 microbicides are in various stages of development and testing with some formulated as a pre-loaded diaphragm, cervical cap, sponge or vaginal ring releasing an active ingredient over time. The different microbicides include antivirals that use different methods of targeting the cells and virus.

"We know if there are more options, it's more likely to be used," said Anna Forbes, deputy director of the Global Campaign for Microbicides, a nonprofit organization based in Washington, D.C.

The first microbicide expected to complete testing is Carraguard, which is made from seaweed. It's being developed by the nonprofit Population Council in New York. Phase III trials are being conducted in three locations in South Africa and will be completed in March 2007.

Analysis of the data should be published by the end of 2007, and if Carraguard shows effectiveness at blocking HIV transmission, the council will seek the first regulatory approval from the South African Medicines Control Council. The council does intend to seek approval afterwards, if the data justifies it, by the U.S. Food & Drug Administration.

"Our goal is to develop a product used by women in the countries hardest hit by HIV and so we will work with regulatory entities in those countries," said Melissa May, director of public information for the council.

New Prophylactic

So far, Carraguard hasn't shown any significant side effects in testing on animals and humans, according to May.

"It's hard" for many of these women to persuade their partners to use condoms," May said. "Women really liked" the concept that they were in control with microbicides, she added. May noted that an additional benefit comes from the increased lubrication that the microbicides provide, a feature received positively both by men and women in testing.

Carraguard is currently being tested for use one hour before intercourse. But later testing and the subsequent versions of microbicides will be tested for use up to 24 hours or even on a monthly basis, according to Dr. Zeda Rosenberg, chief executive of the nonprofit International Partnership for Microbicides of Silver Spring, Md.

That would be a particular incentive for use in areas such as Darfur, where gang rapes are commonplace and a leading source for HIV transmission. Young girls could use microbicides as well, as rapes of children are on the rise. Subsequent microbicides are expected to be tested for effectiveness in blocking HIV transmission during anal sex.

The efficacy of first-generation microbicides is expected to range from 40% to 70%, with the lowest rate averting 18% of infections; and at 60% effectiveness, 35% of infections could be prevented. That could translate into countless lives being saved - more than 25 million people have died of AIDS since 1981, according to a recent report by the United Nations AIDS/World Health Organization. HIV causes AIDS (acquired immunodeficiency syndrome) by damaging white blood cells and other defenses against infection.

Currently, the only known way to spread the HIV virus is through the exchange of bodily fluids such as blood or semen from an infected person.

Cost-Effectiveness

Most versions of microbicides are coming from nonprofit organizations such as the Population Council and from small companies, such as Polydex Pharmaceuticals Ltd. (POLXF) of Canada. Pharmaceutical powerhouses such as Bristol-Myers Co. (BMY), Merck & Co. (MRK) and Johnson & Johnson (JNJ) are providing compounds for research as well.

It makes sense for the nonprofit organizations to take the leading role in the development of microbicides since they are better positioned to conduct trials in the developing world, according to John Moore, a professor of microbiology and immunology at Weill Medical College of Cornell University in New York. Moore has been working with Bristol-Myers and Merck on these projects.

Experts say that among the three compounds from the major companies, the Bristol-Myers and Merck versions stop the HIV virus from entering cells whereas the Johnson & Johnson compound - developed by its Tibotec subsidiary - stops replication of the virus.

TMC120, the Tibotec compound, is in a number of Phase I/II trials, according to Karen Manson, a spokeswoman for Tibotec, which is collaborating with the International Partnership for Microbicides.

The primary audience, at least initially, for microbicides are mostly women who live at the poverty level.

With antiviral therapy, "if it's not inexpensive," it won't be used, said Polly Harrison, director of the Alliance for Microbicide Development of Silver Spring, Md.

This could be very attractive for companies that are interested in "high-volume and low-margin products," the International Partnership for Microbicides' Rosenberg said.

The U.N. estimates that nearly 40 million people worldwide are currently living with HIV and AIDS, including 4.3 million newly infected in 2006. More than half of new infections are occurring in women. Research has shown that women are biologically more vulnerable to infections.

High-Profile Support

Meanwhile, 45 million new HIV infections are expected to occur between 2002 and 2010. Across sub-Saharan Africa, where the highest rates of infection are occurring, UNAIDS/WHO said that women between 15 and 24 years old are at least three times more likely to be HIV-positive than young men.

The dollar amounts targeted for microbicide research have grown tremendously amid public support from former President Bill Clinton, the Bill and Melinda Gates Foundation, the Rockefeller Foundation and others. Five years ago, much of the focus on HIV prevention was on finding a vaccine, but today many experts are more encouraged about the potential immediate impact of microbicides. In 1997, about $28 million was given to fund microbicide research; in 2005 that grew to $163 million.

In a Rockefeller Foundation report, estimates for the net present value of investing in a first-generation microbicide range from negative $65 million to negative $27 million. The second-generation product could be self-funding, with figures ranging from a negative $56 million to a positive $122 million.

Reneuron Seeks FDA OK For Human Stem Cell Trials

Stem cell specialist Reneuron (RENE.LN) said Wednesday it's seeking approval from the U.S. Food and Drugs Administration to start testing its stroke therapy, ReN001, on human patients.

The Surrey, U.K.-based company, which has a market capitalization of less than GBP15 million, wants to conduct the trials on 12 humans. Trials on paralyzed rats showed that they regained some movement after treatment.

The trials would involve the injection of stem cells - taken from an aborted foetus - directly into the patients' brains. The tests would be carried out the Medical Centre at the University of Pittsburgh, with the patients under local anasthetic.

The news, which has sparked much ethical debate, drove ReNeuron shares almost 30% higher in early trading on London's Alternative Investment Market, AIM. At 1002 GMT, they were up 31%, or 4.6 pence, at 19.50 pence.

Chief Executive Michael Hunt said the company has already had "extensive" talks with the regulator and is "pretty confident".

Hunt believes the company will be able to meet concerns they FDA may have over the therapy's safety.

He said his team had sourced all the tissue it needed from one foetus.

"We're open about what we do. Clearly, there's an ethical issue here - but we have no need to extract more tissue, it was done with full maternal consent and it's also important to look at the patient benefit angle."

The use of embrionic stem cells - immature cells that have yet to have a function - destroys the embryo, and research in this area has sparked fierce ethical and moral debate. A different type of stem cell, known as adult cells, can be sourced from umbilical cords and bone marrow.

Hunt said the company will be tapping the market for further cash in the coming year.

The U.K. is seen as a supportive environment in which to conduct stem cell research, and the sector has received considerable Government support.

The Australian Parliament Wednesday lifted its ban on cloning human embryos for stem cell research, despite opposition from the prime minister and other party leaders. However, the anti-stem cell research in the U.S. remains very vocal. In 2001, President George Bush vetoed the use of public funds for stem cell research.

Reneuron has had a bumpy ride on the stock exchange. Founded in 1997 by scientists at London's Kings College, the company initially listed in 2000, valued at around GBP60 million, only to be taken private in 2003 for GBP3.6 million. The group subsequently relisted in 2005 at 25 pence per share.

Drug-Related Suicidal Thoughts May Abate With Age

The Food and Drug Administration said antidepressants appear to increase the risk of suicidal thinking in young adults but that in older adults the risk declines.

The FDA reviewed data from 372 clinical studies involving 11 antidepressants including GlaxoSmithKline PLC's Paxil, Pfizer Inc.'s Zoloft and Eli Lilly & Co.'s Prozac. The studies involved almost 100,000 patients.

The FDA requested the data from drug makers last year in the wake of evidence antidepressants increased suicidal thoughts and behavior in children and adolescents to see if the same risk carried through to adulthood. The drugs carry a "black box" warning about the increased risk in children and adolescents.

The FDA review of the data, which date back to 1985, suggested a "differential risk of antidepressant-induced suicidality across the age spectrum." The agency said in documents posted to its Web site the risk was greater at the younger end of the spectrum and that it declined with age with a likely "protective" effect in adults age 65 and older.

The FDA review was posted ahead of a Dec. 13 advisory committee meeting scheduled to discuss the data and whether updated drug labels are needed to discuss the finding on suicidal thinking in adults. An FDA spokeswoman said the agency planned to update the labels but will seek the panel's input before the labels are changed.

This year, GlaxoSmithKline released an analysis of studies that involved 8,958 patients on Paxil and 5,953 on placebo, or a fake pill. Among the findings was a small but statistically significant increase in suicidal thoughts among young adults patients diagnosed with a major depressive disorder. The company updated Paxil's label warning doctors about the possibility of an increase in suicidal behavior in young adults.

Sanofi Drug Helps Diabetic Sugar Levels

Sanofi-Aventis SA's obesity drug Acomplia can improve blood-sugar levels and weight loss in diabetic patients, according to a study presented at the World Diabetes Congress in South Africa.

The findings from the clinical trial have shown newly diagnosed patients with type-two diabetes who weren't taking antidiabetic drugs had significantly improved blood-sugar levels and lost more weight with Acomplia, compared with a dummy pill over a period of six months. In addition, Acomplia -- also known as rimonabant -- helped raise good cholesterol and control triglycerides, compared with a placebo.

The trial, the second study demonstrating that Acomplia can improve blood-sugar levels in people with type-two diabetes, was carried out on 278 diabetic patients whose sugar levels weren't responding adequately using a controlled diet alone.

Acomplia, hailed as a potential multibillion-dollar "blockbuster" drug and sold in several European countries, is the first in a new class of drugs that help with weight loss by curtailing cravings. Because it also controls blood-sugar levels, it might also become a future breakthrough to treat diabetics.

Given its potential as a diabetes drug, Acomplia is undergoing a number of clinical trials across the diabetes spectrum, from prediabetes patients to people who have to rely on daily insulin injections.

Acomplia's benefits shown in the trial support its use as a diabetes drug that is completely different from antidiabetic pills now on the market, said Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center, an investigator in the trial.

Among the side effects reported by patients taking Acomplia were nausea, depressed mood and skin tingling, which led to a discontinuation rate of 9.4%, compared with 2.1% in the placebo patients.

"While Sanofi claims Acomplia is an important treatment for diabetes, the data have to be tempered with the side-effect issues," said Navid Malik, an analyst with London-based brokerage Collins Stewart.

In the trial, more than 50% of patients taking Acomplia achieved blood-sugar levels below 7%, the target for good glucose control, as recommended by the American Diabetes Association.

In addition, these improvements were linked to a weight loss of 14.7 pounds, compared with 5.9 pounds in patients on placebo.

Around 5% of adults world-wide have been diagnosed with diabetes, with type-two constituting the majority of diabetes cases in developed countries.

Glaxo Avandia Can Slow Diabetes Progression

Long-term treatment with GlaxoSmithKline PLC's (GSK) blockbuster drug Avandia is more effective in slowing the progression of early-stage diabetes than two older treatments, according to a study published Monday in the New England Journal of Medicine.

The trial, presented Monday at the World Diabetes Congress in Cape Town, South Africa, showed that initial treatment of type-2 diabetes with Avandia slowed disease progression more effectively than did metformin and glyburide, which are currently used as first-line treatments.

Avandia is GlaxoSmithKline's second best-selling drug, with sales of GBP1.3 billion last year. It is prescribed to patients who do not respond to treatment with older anti-diabetics.

Compared with metformin, Avandia showed a risk reduction of 32%. This increased to 63% when it was compared with glyburide. The minimum target required in the trial, which studied 4,360 newly diagnosed diabetes patients over the course of four years, was a risk reduction of 30%.

However an accompanying editorial in the journal said that given Avandia's modest benefits, higher cost and side-effects, metformin remains "the logical choice" in the initial treatment of diabetes.

With all three drugs there was a high rate of patients dropping out of the trials due to adverse events. Around 60% of patients completed the study, the researchers said.

Treatment with Avandia highlighted a number of side-effects that are usually linked to the use of the drug, such as weight gain, increased levels of bad cholesterol and fluid retention.

However, Lawson Macartney, head of GlaxoSmithKline's cardiovascular and metabolic medicine development center, told an agency that the data underscore the fact Avandia performs significantly better than older drugs.

"Metformin performed well, but Avandia performed better," he said, noting that the data also support the effectiveness of combination therapy with both drugs in earlier-stage diabetes.

The trial showed that Avandia had clearer beneficial effect on older people and on those with a larger waist circumference.

Type-2 diabetes, the most common form of diabetes, is a chronic disease marked by high levels of sugar in the blood, and is more prevalent among older, overweight people. In addition to Avandia, GlaxoSmithKline's diabetes portfolio includes Avandamet, which is a combination of Avandia and metformin, as well as Avandaryl, which combines Avandia with glimepiride, an older oral antidiabetic.

GlaxoSmithKline is planning to file the results of the trial with drug regulators worldwide in the first half of 2007, Macartney said.

Bayer,Onyx:Nexavar Trial Doesn't Meet Targets

Bayer AG (BAY) and its U.S. partner Onyx Pharmaceuticals Inc. (ONXX) said Monday that cancer drug Nexavar didn't meet the companies' primary targets in a trial to treat skin cancer.

Recently, shares of Bayer were up 5 cents at $51.90. Shares of Onyx were down $5.20, or 29.7%, at $12.30.

Late-stage Phase III tests on the treatment of advanced melanoma showed no improvement when Nexavar was compared with drugs already used to treat this kind of cancer, the companies said.

The target set by the companies was to improve the progression-free survival rate of patients suffering from advanced melanoma.

"This trial does not change our commitment to, and belief in, Nexavar," said Hollings Renton, chairman, president, and chief executive of Onyx.

The drug is already approved and on the market to treat renal cancer in the U.S., Europe and other countries.

Late November, Bayer reported third-quarter sales of the drug of EUR37 million and said it expects full-year 2006 sales to be over EUR100 million.

The companies are also evaluating Nexavar for treatment of liver and non-small-cell lung cancer, and are conducting the last of three clinical trials.

Pfizer Halt Of Torcetrapib Seen A Heavy Blow

Pfizer Inc. (PFE) halted development of a drug to boost good cholesterol that was the most important medicine in its pipeline, after more patients than expected died during a large clinical test.

The unanticipated excess of deaths, whose number was small but wasn't specified by the company, became known Saturday after a board of independent experts reviewed the latest data from a 15,000-patient test of the drug called torcetrapib.

Citing patient safety, Pfizer said in a statement that it is terminating all clinical tests of torcetrapib and its plans to bring the drug to market.

The failure of torcetrapib is a heavy blow to Pfizer, the world's largest drug maker by sales. The company had bet on torcetrapib to take the place of cholesterol-fighter Lipitor, the company's best-selling product with $12.19 billion in revenue last year. Lipitor could lose patent protection as soon as 2010.

Doctors and investors have been watching torcetrapib closely because it seemed able to profoundly raise the type of cholesterol - called HDL - that could help keep arteries clear.

But torcetrapib has been dogged by safety worries. The medicine showed a tendency to raise blood pressure as it also raised good cholesterol.

Still, the increase in deaths for the patients who received torcetrapib was a shock. "We were very surprised ," said Philip Barter, director of the Heart Research Institute in Australia and chairman of the committee overseeing the large study, in the Pfizer statement. "We believed that the study was coming along as expected," he said.

Dr. Steven Nissen, chairmain of cardiovascular medicines at the Cleveland Clinic, called the setback "terribly disappointing." Nissen is the leader of another clinical test of torcetrapib to see if the medicine reversed the plaques that clog arteries feeding the heart. He said that finding new drugs to raise HDL safely and effectively remains an important goal. "We still don't know if this is a problem specific to torcertrapib or this approach to raising HDL isn't going to work."

The test that detected the more serious problems was a 15,000-patient study that was supposed to continue until 2009 or early 2010. Half the patients received tocetrapib plus Lipitor. The other half got Lipitor alone. Pfizer said the study cast no doubt on the safety and effectiveness of Lipitor.

Some analysts thought that the blood pressure problems that were already known would doom torcetrapib. Other companies, including Merck & Co. (MRK) and Roche Holding AG (RHHBY), were working on alternatives to torcetrapib that don't appear to increase blood pressure.

Only last Thursday Pfizer management had affirmed confidence in torcetrapib at a meeting with analysts to review the company's pipeline. The company affirmed its plan to seek Food and Drug Administration approval of torcetrapib taken in combination with Lipitor in the second half of 2007.

During the meeting, Pfizer research president John LaMattina said, "We believe this is the most important new development in cardiovascular medicine in years."

FDA Weighs Celebrex Studies On Juvenile Arthritis

Pfizer Inc. might have to conduct further studies on its pain reliever Celebrex before it is approved to treat rheumatoid arthritis in children, the Food and Drug Administration staff said.

Celebrex, which is approved to treat arthritis in adults, has faced safety concerns over an increased risk of heart attacks and strokes for those who take it.

The drug belongs to the same class of painkillers as Merck & Co.'s Vioxx. Merck pulled the drug from the market in 2004 after its studies showed Vioxx doubled the risk of heart attacks and strokes. Pfizer continued to sell Celebrex after it strengthened label warnings about its risks.

This year the New York drug maker requested FDA approval for Celebrex to treat juvenile rheumatoid arthritis in patients ages two years and older. The FDA is holding a meeting today with an outside panel of experts, who will be asked to weigh the risks and benefits of the drug for the treatment in children.

According to documents posted on the FDA's Web site, about 30,000 to 60,000 children in the U.S. suffer from the condition. In severe, uncontrolled cases, rheumatoid arthritis can cause permanent disability.

While there are other drugs approved to treat the condition in children, "for some patients these approved products may provide limited efficacy or intolerable side effects," the FDA said. Those drugs include aspirin, ibuprofen and naproxen to treat the pain.

On the safety of the drug, the staff said "a key consideration" in assessing the issue "is the evidence of increased risk of cardiovascular adverse events in adults." Heart risks to children who take Celebrex long term are unknown.

In a trial conducted with children, the most common adverse events of Celebrex were certain infections and infestations, and nervous-system disorders. Compared with naproxen, common adverse events with Celebrex were similar in type and frequency, the staff said.

Drug Pipelineline Series: Phase III, 27 Nov - 4 Dec, 2006

Dynavax's HEPLISAV™ Hepatitis B Vaccine Shows Statistically Significant Results in Phase 3 Trial

Dynavax Technologies Corporation announced statistically significant results from the primary endpoint analysis of a Phase 3 trial comparing HEPLISAV, its hepatitis B virus (HBV) vaccine, to GlaxoSmithKline's Engerix-B® vaccine in a difficult-to-immunize population of older adults. The primary endpoint is seroprotection four weeks after the third immunization.

The data show that after three doses, HEPLISAV provided seroprotection to 100% of subjects versus 73.1% for Engerix-B (p < 0.0001). The greatest difference in seroprotection after three doses was seen in subjects 56 to 70 years of age where HEPLISAV provided 100% seroprotection and Engerix-B provided 56.1%. Data for the entire study population show that after two doses, HEPLISAV provided 98.5% seroprotection versus Engerix-B's 25%. Furthermore, HEPLISAV provided a level of immunity as measured by geometric mean concentrations of anti-HBsAg antibodies 18.5 times higher than Engerix-B four weeks after the third dose.
The Phase 3 trial enrolled more than 400 seronegative subjects, 40 to 70 years of age, at study sites in Singapore, Korea and the Philippines. One group of subjects received three doses of Dynavax's HBV vaccine; the other group received three doses of Engerix-B.

Drug Pipelineline Series: Phase II, 27 Nov - 4 Dec, 2006

CHEMOCENTRYX PRESENTS DATA FROM CROHN'S DISEASE STUDY

ChemoCentryx has presented data from a Phase II study of the company's drug candidate Traficet-EN (CCX282-B), a first-in-class, orally active, anti-inflammatory agent that targets the chemokine receptor known as CCR9, at the 2006 Crohn's and Colitis Foundation of America's annual meeting. New data were presented from a trial in patients with moderate-to-severe Crohn's disease analyzing the effect of Traficet-EN on lowering pro-inflammatory cytokine and chemokine concentrations in the intestine.

BAYER PUBLISHES RESULTS OF ANTICOAGULANT STUDY

Bayer has announced that results of a Phase II trial of the novel oral anticoagulant rivaroxaban, a direct Factor Xa inhibitor, have been published in Circulation. In the trial, rivaroxaban demonstrated that it may have similar safety and efficacy to subcutaneous enoxaparin (the current standard), for the prevention of venous thromboembolism (VTE) in patients undergoing elective total hip replacement surgery.

The publication completes the Phase II program with rivaroxaban for the prevention of VTE after major orthopaedic surgery and contains the full data set from the once-daily dosing trial; results from twice-daily trials in hip and knee replacement surgery have already been published. These data taken together formed the basis of the decision to initiate the Phase III program with rivaroxaban for the prevention of VTE after orthopaedic surgery using a once-daily dosing regimen.

Cleveland BioLabs Initiates Phase II Hormone-Refractory Prostate Cancer Trial for Curaxin CBLC102

Cleveland BioLabs, Inc. announced the initiation of its Phase II efficacy study for Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer at the Cleveland Clinic and Case Western Reserve University Hospital.
Curaxin CBLC102 is a safe, oral drug used in the past to treat malaria that demonstrates efficacy in vitro, in animal models, and in live tumors removed from patients. Initial test results indicate that CBLC102 can be effective against a number of malignancies, including hormone refractory prostate cancer, renal cell carcinoma (a highly fatal form of kidney cancer), and soft-tissue sarcoma. The FDA permitted Cleveland BioLabs to advance directly to Phase II studies, based on CBLC102's historic safety profile.

Sangamo BioSciences Initiates Phase 2 Clinical Trial of Novel Therapy for Diabetic Neuropathy

Sangamo BioSciences, Inc. announced that the company has initiated a multi-center Phase 2 clinical trial of SB-509 for diabetic neuropathy (DN). The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF™), designed to upregulate the vascular endothelial growth factor A (VEGF-A) gene.

Phase II Data Shows Ovation's Novel Compound Clobazam to Be Well Tolerated in Patients With Catastrophic Epilepsy

Results from the first study in the United States designed to evaluate the safety and efficacy of clobazam as adjunctive therapy in patients with Lennox-Gastaut syndrome (LGS), one of the most severe forms of childhood epilepsy, demonstrated that clobazam is well tolerated. In the trial, clobazam was shown to be effective in significantly reducing drop (or atonic) seizures, the most debilitating of the LGS seizure types, which can result in severe trauma to the brain and body, by 85.3 percent compared to baseline (in the high dose group versus 12 percent in the low dose group; P=.0001). Adverse events leading to the discontinuation of clobazam were rare. Data were presented at the North American Regional Epilepsy Congress.
This phase II, multi-center, randomized, double-blind, dose-finding clinical trial was the first study conducted in the U.S. to evaluate the safety and efficacy of clobazam as adjuvant therapy in patients with LGS. Sixty-eight patients (ages 2 to 26 years) with LGS were randomized to two treatment groups with a low dose (target of 0.25 mg/kg/day) of clobazam or a high dose (target of 1.0 mg/kg/day) for a total treatment duration of up to 10 weeks.

EPIX Announces Full Results from Phase 2a Clinical Trial of EP-2104R Presented at RSNA Annual Meeting

EPIX Pharmaceuticals, Inc. announced the results from a Phase 2a clinical trial of EP-2104R, a novel fibrin-binding thrombus (clot) imaging agent, as presented during an oral presentation at the Radiological Society of North America (RSNA) Annual Meeting in Chicago, Illinois. The results of the Phase 2a trial found that EP-2104R was able to detect blood clots not previously seen on magnetic resonance imaging (MRI) and enhanced the images of clots previously seen on MRI. Blood clots are a major underlying cause of several diseases including deep vein thrombosis, pulmonary embolism, heart attack and stroke, and identifying a minimally invasive method for detecting clots would address a substantial medical need.

Drug Pipelineline Series: Phase I, 27 Nov - 4 Dec, 2006

Ligand Announces Initiation of Clinical Trials for Thrombocytopenia Drug, LGD 4665

Ligand Pharmaceuticals Incorporated announced that the Company is initiating Phase I clinical trials of LGD 4665, an oral, small molecule drug that mimics the activity of thrombopoietin (TPO), a growth factor that promotes growth and production of blood platelets.

Thrombocytopenia or low platelet count is a common clinical finding associated with a diverse group of clinical disorders or conditions affecting platelet production and/or survival. Prevalent clinical disorders where platelet loss or dysfunction leads to significant morbidity include idiopathic thrombocytopenia purpura (ITP), myelodysplastic syndrome, liver dysfunction associated with hepatitis C viral and severe cirrhosis, chemotherapy-induced thrombocytopenia (CIT) as well as a number of other disorders. Current therapeutic options are mostly palliative, including steroids, immunosuppresants, splenectomy and, for the most severe thrombocytopenias, platelet transfusion.

ARROW'S HEPATITIS C TREATMENT ENTERS PHASE I STUDY

Arrow Therapeutics has begun a Phase I study of A-831, a small-molecule antiviral inhibitor of the hepatitis C virus. The study will evaluate the safety, tolerability and pharmacokinetics of single escalating doses of A-831 in healthy volunteers in the UK.

A-831 targets the NS5a protein, a novel mechanism of action, and is the first NS5a inhibitor to enter clinical trials. The drug showed good safety and pharmacokinetics in preclinical studies and excellent potency in the replicon assay. A-831 is the first compound from Arrow's broad approach to the NS5a target.
The current standard treatment for hepatitis C, pegylated interferon plus ribavirin, has a poor side effect profile and is only effective in around 50 percent of patients, according to Arrow. Patients often need multiple drugs in combination therapy to overcome drug resistance.
The company also plans to develop other drugs for hepatitis C, which will be licensed to other companies between the preclinical and Phase IIb stages.

SEATTLE GENETICS BEGINS TRIAL OF HODGKIN'S LYMPHOMA DRUG

Seattle Genetics has initiated a Phase I clinical trial of SGN-35 for patients with Hodgkin's lymphoma and other CD30-positive hematologic malignancies. SGN-35 is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics' proprietary technology to empower antibodies by linking them to potent cell-killing drugs.
The single-agent, dose-escalation study is designed to evaluate the safety, pharmacokinetic profile and antitumor activity of SGN-35 in patients with relapsed or refractory CD30-positive hematologic malignancies, including Hodgkin's lymphoma. The trial is expected to enroll up to approximately 40 patients at multiple centers in the United States.

SGN-35 is an ADC composed of an anti-CD30 antibody joined by an enzyme-cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in a targeted cell-killing effect. Treatment with SGN-35 resulted in complete tumor regressions in preclinical models of Hodgkin's disease and anaplastic large-cell lymphoma.

Pain Therapeutics Announces Positive Phase I Study Results With PTI-202

Pain Therapeutics, Inc. announced positive results from a Phase I clinical trial evaluating PTI-202, the Company's second abuse- resistant opioid painkiller.
This clinical trial was designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of a single, oral dose of PTI-202 in healthy volunteers. We believe results also indicate PTI-202 is safe and well-tolerated and its release profile appears well-suited to use with a chronic pain population. There were no unexpected adverse events in this trial.
PTI-202 is a novel abuse-resistant formulation of an opioid painkiller. Its active pharmaceutical ingredient remains undisclosed. PTI-202 is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimize the risks of drug diversion, abuse or accidental patient misuse.