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news.Biopharmaceutical company Novacea has ended its Phase III Ascent-2 clinical trial of Asentar, the company's investigational cancer therapy for the treatment of patients with androgen-independent prostate cancer, due to an imbalance of deaths between the two treatment arms, as observed by the data safety monitoring board for the clinical study.
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Novacea and its partner, Schering-Plough, plan to fully analyze the clinical data to attempt to understand the cause of the higher death rate in the Asentar plus Taxotere (docetaxel) treatment group. The study was comparing the benefits of weekly Asentar plus Taxotere to the current standard of care in the treatment of androgen-independent prostate cancer.
John Walker, CEO of Novacea, said: “The safety of the patients in our trials is our top concern. As such, Novacea and Schering-Plough have decided to end the ASCENT-2 trial, however, the product development alliance will continue. The findings in ASCENT-2 are extremely surprising and disappointing to us, given the promising clinical activity that we observed in our Phase II Ascent trial. Importantly, preliminary analysis has not identified any unexpected safety findings with Asentar.”
Mr. Walker, also said: “We have informed all relevant constituents, most importantly the clinical trial sites treating patients and the regulatory authorities, and have suspended enrollment in other ongoing or planned trials in other indications until we have had a chance to assess the data more completely.”