Eisai heart drug may lower heart risks

Japanese drugmaker Eisai's blood clot candidate E5555 may be able to reduce heart attacks, strokes and cardiovascular deaths without increased serious bleeding risks, researchers say. Scientists evaluated E5555, a new protease-activated receptor 1 inhibitor, in two Phase II trials in Japanese patients to assess the drug's safety and tolerability. The researchers also wanted to determine its effects on major adverse cardiac events (MACE) and platelet aggregation in acute coronary...

Athersys buoyed by upbeat PhI stem cell data

Athersys (ATHX) has benefited from some upbeat buzz about its positive--though small--early-stage results for a prospective new stem cell therapy for victims of a heart attack. Patients who received a medium and high dose of its MultiStem therapy--a stem cell treatment derived from patients' bone marrow cells--demonstrated significantly improved heart function in a Phase I trial. A total of 19 patients were treated with the experimental therapy. "We are encouraged by the results of this Phase I...

Antares Pharma shares jump on upbeat PhIII results

Shares of Antares Pharma got a nice bounce after the developer touted positive late-stage data for its experimental bladder control gel therapy. And Antares says it's now on track to file an NDA for Anturol before the end of this year. "We are delighted with the positive outcome of this Phase III trial, as both doses demonstrated a statistically significant reduction in the primary endpoint of urinary incontinence events as well as a low incidence of reported side effects," said Antares CEO...

Therapeutic HIV vax shows promise in small trial

The flurry of news coming from the International AIDS Conference largely overshadowed the results of a small South African study testing a therapeutic vaccine in 60 HIV-positive volunteers not yet eligible for antiretroviral therapy. And the research could have great benefit, as it could keep patients healthy for longer and delay the point at which people need to begin ART.  The trial was actually testing for safety, and researchers did not expect to see...

NovaBay’s impetigo drug aces Phase II trial

NovaBay Pharmaceuticals' lead drug candidate NVC-422 was shown to be safe and effective in a mid-stage trial. The drug was tested at three doses against the contagious skin infection impetigo, including infections caused bymethicillin-resistant Staphylococcus aureus (MRSA). Results showed a trend towards a dose response. NovaBay says in a statement that it plans to "aggressively" pursue development of NVC-422 as a first-line treatment for a range of topical infections....

XenoPort’s lead program suffers another big setback

A bad year for XenoPort (XNPT) just got substantially worse. The Santa Clara, CA-based developer says that its lead program--which is partnered with GlaxoSmithKline--flunked a Phase IIb trial for migraines, apparently scuttled by a high placebo effect.  And XenoPort's already battered share price plunged more than 25 percent as investors digested the fresh round of sour reports. GSK1838262/XP13512, also known as Horizant, failed to perform significantly better than a placebo among the...

Intercell vaccine patch fails PhII trial

Intercell's investigational vaccine enhancement patch system for avian H5N1 influenza has failed a Phase II study. The company is working under a contract with HHS to develop a dose-sparing approach with potential for a single dose immunization combining a H5N1 vaccine with Intercell's LT adjuvant patch. The mid-stage study was designed to determine the safety and the optimal combination/dose of an injectable H5N1 influenza vaccine and Intercell's VEP applied at the injection site. A total of...

Affymax shares plunge on PhIII cardio issues for Hematide

Affymax says that a slate of four late-stage trials for its anemia drug Hematide demonstrated that the therapy is non-inferior to Amgen's Epogen and Aranesp, hitting its primary endpoints and putting it on a path to file for an FDA approval. But a stumble on cardio risks in a key sub-group of patients captured the unwelcome attention of analysts, with AFFY shares plunging 65 percent this morning. Altogether 2,609 patients were studied in the four late-stage studies in Europe and the U.S., with...

Phase III osteoarthritis pain trial is a winner for Pfizer

Pfizer ran the table in a late-stage study of tanezumab, a protein inhibitor that the pharma giant is touting as a leading contender to go on to become the world's first approved biologic for pain. The pharma giant recruited 690 patients for the trial who suffered from chronic knee pain from osteoarthritis but were either unable to take an NSAID pain therapy or its Cox-2 inhibitor Celebrex or didn't benefit sufficiently from the meds. Patients in all three dose groups--2.5 mg, 5 mg and 10...

Adolor shares sink after placebo effect scuttles PhIIa pain trial

Shares of Adolor (ADLR) took an 18 percent dive yesterday evening after the company announced that two of its pain meds partnered with Pfizer had failed a mid-stage clinical trial. Pfizer paid $30 million upfront to collaborate on ADL5859 or ADL5747, two therapies that were tested alongside oxycodone for its effectiveness in reducing pain among patients with osteoarthritis. Exton, PA-based Adolor said that an unusually high placebo response eliminated any statistically significant drug...