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June 17, 2004

Final Phase II Data Shows That Onyvax-P May Significantly Extend Progression Free Survival For Men With Advanced Prostate Cancer

London, UK – 17 June, 2004: Onyvax Limited, the biotechnology company developing novel cancer therapies, today announced final Phase II clinical data showing that treatment with Onyvax-P, the company’s investigational immunotherapy, may provide a clinical benefit to men with advanced (hormone-resistant) prostate cancer (HRPC).

The data show that in 26 men whose disease has not metastasised to the bones (Cohort One), the median progression free survival (PFS) was 58 weeks which compares favourably with recently published data of 26-29 weeks (Journal of Clinical Oncology (2000) 18:3894-3903; Atlas of Clinical Urology (2002), Ed. Peter T. Scardino MD). All patients also received standard of care, which is a continuation of hormone therapy plus supportive care, when appropriate.

In addition to this PFS benefit, patients also showed biochemical and immunological responses to the treatment. 11 patients (42%) experienced a prolonged, statistically significant reduction in prostate specific antigen (PSA) velocity. PSA is a blood marker for prostate cancer and at this stage of the disease generally increases exponentially until death. According to studies presented at this year’s ASCO meeting, a prolonged reduction in PSA velocity correlates with and is a predictor of prostate cancer disease progression and survival in HRPC (2004 ASCO Annual Meeting abstracts 4506 and 4554). Furthermore, vaccinated patients who showed a clinical slowdown in disease exhibited evidence of immunological activation, including proliferation of patient T cells and enhancement of cytokine responses. The treatment was very well tolerated and side effects were limited to mild fatigue and local injection-site reactions.

“These findings add to the growing body of evidence that immunotherapies may be effective in treating cancer. Onyvax-P may provide a new option for men who have limited treatment alternatives when their PSA level is rising but are otherwise asymptomatic,” said Dr Hardev Pandha, MD, Consultant in Medical Oncology at St George’s Hospital Medical School, London and principal investigator for the study. “This is a novel approach to treat prostate cancer that appears to be safe and feasible. We hope that immunotherapies such as Onyvax-P alter the natural history of the disease and the data from this trial provide a clear basis for the initiation of larger Phase III randomised studies in this group of patients.”

“This study was designed to assess whether to conduct further trials of this product. Based on the clinical, PSA and immune response data generated, the case for further investigation is overwhelming,” said Anthony Walker, PhD, Chief Executive at Onyvax Limited. “Manufacturing of material for pivotal trials is underway and we hope to start patient recruitment in early 2005.”

The trial recruited 48 patients in two prospectively defined cohorts. The first cohort recruited 28 patients with HRPC with no bone metastases. The second cohort recruited patients with HRPC with bone metastases but no clinical symptoms. Two patients in Cohort One did not receive treatment due to protocol violation. Data from Cohort Two, which recruited men with asymptomatic metastatic HRPC is still being collected and will be presented later in the year. Survival data is being collected for both cohorts.

The trial enrolled patients with all levels of Gleason scores (a measure of the aggressiveness of prostate cancer) including the highest risk patients. The median Gleason score in Cohort One was 7.7.

Disease progression in the trial was defined by the development of new lesions in the bone or soft tissue; the requirement of palliative treatment with an opioid analgesic for new disease-related pain; the occurrence of new disease-related symptoms that required intervention such as treatment with chemotherapy, radiation or surgery; the occurrence of a clinical event determined by the investigator to represent disease progression; or death.

For further information, please contact:

Onyvax Financial Dynamics
Dr Anthony Walker / Robert Johnson Francetta Carr / Lucy Briggs

+44 (0)208 682 9494 +44 (0)20 7831 3113


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