Gilead Sciences (GILD) said darusentan, the company’s experimental drug to treat resistant hypertension, failed in a late-stage clinical trial. Darusentan, an endothelin receptor antagonist, did not achieve its two primary endpoints in a comparison to a placebo. “We are disappointed that darusentan did not achieve its primary endpoints in this study,” said Norbert Bischofberger, Gilead’s executive vice president of research and development and chief scientific officer. “As a result, we think it would be challenging to define an expedient path forward. We would likely be required to initiate another phase III study and would rather allocate our resources to other promising research and development opportunities in our pipeline.”
Elan (ELN) and Transition Therapeutics (TTHI) said they have modified a clinical trial of their experimental Alzheimer’s drug to remove the two high doses uses after concerns about adverse events including the death of nine patients. The companies said the decision was made in concurrence with the Independent Safety Monitoring Committee following a review of the ongoing ELND005-AD201 study. A direct relationship between ELND005 and the deaths has not been established. The Independent Safety Monitoring Committee and both companies agreed that the tolerability and safety data are acceptable among patients receiving the lower dose of the drug and that the blinded study should continue for this dose and the placebo group.
Addex Pharmaceuticals said it decided to end prematurely a study of its experimental drug ADX10059 for the prevention of migraine because of safety concerns. The Swiss company said a routine safety monitoring of blinded data revealed an incidence of abnormalities in liver function tests that is higher than expected. The abnormalities are apparent from day 28 of dosing but the incidence and severity appear to increase progressively with increasing duration of participation in the study. Despite the fact that the treatment allocation remains blinded, Addex said it believes that the risk-to-benefit profile of the drug observed in the study is not sufficiently favorable to justify continuation of the trial.
A gel designed to prevent AIDS infections produced by Chadds Ford, Pennsylvania-based Endo Pharmaceuticals (ENDP) failed in a clinical trial in Africa, according to the funders of the trial. The largest international clinical trial to date into a preventative HIV gel found no evidence that the vaginal microbicide PRO 2000 reduces the risk of HIV infection in women, researchers reported. The Department for International Development and the U.K. Medical Research Council funded the trial. To date, no microbicide has been shown to be effective against HIV infection.
A U.S. Food and Drug Administration advisory panel rejected early use of OSI Pharmaceuticals’ (OSIP) and Genentech’s (DNA) Tarceva. The Oncologic Drugs Advisory Committee voted 12 to one recommending against approval of the daily pill Tarceva for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer whose cancer has not progressed following first-line treatment with platinum-based chemotherapy. The FDA is not bound by the recommendations of its advisory committees and the agency is expected to make a decision on whether to approve Tarceva for this use by January 18, 2010.
Memphis-based GTx (GTXI) said it laying off nearly 30 percent of its staff as a result of the delay in the potential commercialization of toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy. Employees remaining with the company will not receive an increase in base salaries for 2010 or any bonus compensation for 2009. GTx is retaining its senior commercial and medical leadership team in order to remain prepared for the potential commercialization of toremifene. GTx expects to record a charge of approximately $1.1 million related to the workforce reduction in the fourth quarter of 2009.
Hawaii Biotech filed for Chapter 11 bankruptcy protection. The privately-held Hawaii-based vaccine maker plans to continue to develop vaccines to protect against West Nile virus, dengue fever, and tick-borne encephalitis.
Vion Pharmaceuticals (OTC:VION) filed for Chapter 11 bankruptcy protection and plans to continue to operate its business as a debtor-in-possession. The bankruptcy fining became necessary as a result of the U.S. Food and Drug Administration’s complete response letter relating to its application to begin marketing Onrigin, a treatment for acute myeloid leukemia and high-risk myelopysplasia. The FDA wants Vion to conduct an additional trial to demonstrate the efficacy and safety of Onrigin in the patient population proposed for the indication, which Vion cannot afford to do.
Quebec City-based AEterna Zentaris (AEZS) said Sanofi-Aventis (SNY) will terminate their agreement for the development, commercialization and licensing of cetrorelix in benign prostatic hyperplasia for the U.S. market effective January 9. The announcement follows the release of data from a late-stage clinical study for cetrorelix in BPH that showed the experimental drug failed to meet its primary endpoint.
Ark Therapeutics Group (OTC:ARKTF) said that it has received notice from the European Medicines Agency that the European Committee for Medicinal Products for Human Use has recommended that the company’s application to begin marketing its gene-based therapy to treat operable brain cancer Cerepro should not be approved based on data provided by the company. Ark said it intends to provide additional data to support re-examination through the standard appeal procedure. The main underlying objection from the regulator that had not been resolved concerns specifically whether or not patients treated with Cerepro might for some reason, have been left longer by surgeons prior to re-intervention than those who did not receive Cerepro. As time to re-intervention is the main efficacy measure in the primary endpoint, the assessors determined that they could not recommend approval based on the data presented by Ark so far.