AZ's zibotentan flunks late-stage prostate cancer trial

AstraZeneca has suffered a setback in its oncology drug development strategy. The pharma giant reported that the closely watched prostate cancer therapy zibotentan failed a late-stage trial. At a minimum, the Phase III failure is forcing AstraZeneca to put any plans on filing for regulatory approval on hold. The therapy is in two other late-stage trials as well.

TheStreet's Adam Feuerstein had been keeping a watchful eye on the drug's progress, noting its potential to go head-to-head with Dendreon's newly approved Provenge. Zibotentan would have offered advanced hormone refractory prostate cancer patients an oral alternative to Provenge. But that threat diminished significantly with the news of the Phase III data.

"Based on this study result, AstraZeneca plans no regulatory submissions for zibotentan at this time," the company reported in a terse statement. The full data will be displayed sometime next year.

Earlier this month researchers reported that zibotentan's survival benefit in a Phase II study was actually narrower than had been first reported, dropping below the level of statistical significance. AstraZeneca has also been hit with trial failures for Recentin in colon cancer and Vandetanib in non-small cell lung cancer. AstraZeneca, however, has filed for approval of Vandetanib and has five other cancer programs in mid-stage development.

- check out the AstraZeneca release
- here's the story from TheStreet
- read the report from the Wall Street Journal