Dendreon Soars on Provenge Interim Data, but BLA to Wait

Interim Phase III data showed that Provenge cut the risk of death vs. placebo, sending shares of Dendreon Corp. soaring 33.3 percent, even though results failed to meet the prespecified endpoint that would have allowed the firm to halt the trial early and file an amended biologics license application. As reported by the independent data monitoring committee for the 512-patient IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, 24-month data showed a 20 percent reduction in the risk of death in the Provenge (sipuleucel-T) arm relative to placebo, with a hazard ratio of 0.80, in men with metastatic androgen-independent prostate cancer. Despite missing the interim endpoint, Mitchell Gold, president and CEO of the Seattle-based firm, told investors during a conference call that his firm was "encouraged" by the... [read full story]                    

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