Onyvax, a London, UK-based biotechnology firm developing novel cancer therapies, says that its European Phase IIb clinical trial evaluating its cancer vaccine Onyvax-P has completed enrollment. The company expects to reach the primary endpoint of progression-free survival in the first half of 2009. If positive, the firm plans to initiate Phase III clinical trials shortly thereafter.
Anthony Walker, chief executive of Onyvax, said: "we are grateful for the tremendous support we received from both the patient and medical communities for this study and are excited to complete this important step in the development of Onyvax-P. We look forward to completing the trial next year, starting Phase III clinical trials and bringing this cancer vaccine to the market."
The clinical trial protocol called for a total of 75 evaluable patients across Europe who have non-metastatic, hormone refractory prostate cancer, with two-thirds of patients receiving active therapy and the rest getting placebo. Patients are receiving 15 administrations of vaccine over 12 months to generate and maintain a strong anti-cancer immune response throughout the treatment period.
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