London, UK – 17 March, 2008: Onyvax Limited, the biotechnology company developing novel cancer therapies, today announced that its European Phase IIb clinical trial evaluating Onyvax-P has completed enrolment. Onyvax-P is the company’s therapeutic cancer vaccine designed to slow down prostate cancer progression. Onyvax expects to reach the primary endpoint of progression free survival in the first half of 2009. If positive, the company plans to initiate Phase III clinical trials shortly thereafter.
Dr. Anthony Walker, CEO 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 receiving 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.
Previous Phase IIa data for Onyvax-P, published in Clinical Cancer Research, June 15th 2005 edition, showed:
§ mild side effects, typical of vaccines;
§ significant slowing of PSA rise in 40% patients (a blood marker for prostate cancer); and
§ on average, time to disease progression (i.e. clinical deterioration) took 58 weeks compared to historical experience of 29-30 weeks.
Prostate cancer is one of the most prevalent cancers that affects the male population. Each year approximately 410,000 patients are diagnosed with the disease in the seven major markets, of which 250,000 cases are in the United States alone. The incidence of hormone resistant prostate cancer in the seven major markets is over 36,500 patients per annum, with a total patient population of 220,000.
For further information, please contact:
Onyvax Financial Dynamics
Dr Anthony Walker / Rob Johnson
+44 (0)20 8682 9119
+44 (0)20 7831 3113