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UPDATE: AstraZeneca Drug Zibotentan Fails In Prostate Cancer Study

AstraZeneca PLC's (AZN) oncology development program suffered a fresh setback Monday with news its experimental prostate cancer pill Zibotentan failed in a late clinical trial to significantly improve overall survival.

Zibotentan is being studied in more than 3,000 men in the drug maker's ENTHUSE (Endothelin A Use) clinical trials to evaluate the candidate medicine's efficacy and safety in extending survival in men with advanced prostate cancer which has already spread to the bone.

The treatment was being studied in a randomised, placebo controlled phase III trial called Study 14, evaluating zibotentan at a dosage of 10 milligrams that was added to standard of care treatment in 594 patients having metastatic castration resistant prostate cancer, or CRPC. The company said it is discussing the implications of Study 14 with investigators and that full results will be published in 2011.

Prostate cancer primarily affects men over the age of 50. It is the most commonly diagnosed male cancer in many western countries and its incidence is increasing.

There are two other studies in the ENTHUSE trial programme: Study 15 will evaluate zibotentan versus placebo in men whose disease has not yet metastasised, while Study 33 will evaluate zibotentan plus chemotherapy, versus chemotherapy alone, in men whose disease has metastasised and who have been prescribed treatment with chemotherapy.

Zibotentan's disappointing results in Study 14 follows unsuccessful trials for two other AstraZeneca pills--Recentin in colon cancer and vandetanib in non-small cell lung cancer. However, the U.K.-based company last week filed vandetanib for regulatory approval in the U.S. and Europe for advanced medullary thyroid cancer.

"We remain committed to the future discovery of oncology products," a spokesman for AstraZeneca said Monday.

He noted that AstraZeneca has five oncology products in phase II studies: Olaparib for ovarian and breast cancer, AZD1152 for haematological malignancies, as well as AZD8931, AZD6244, and AZD7762 which are being investigated for solid tumours.

-By Sten Stovall, of Dow Jones Newswires, [e-mail], [phone]