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February 21, 2005

Onyvax US Clinical Advisory Board Reviews Phase II Data And Gives Input To Onyvax-P Late-Stage Clinical Trial Design In Prostate Cancer

London, UK – 21 February 2005: Onyvax Limited, the biotechnology company developing novel cancer therapies, today announced at the American Society of Clinical Oncology Prostate Symposium in Orlando that its US Clinical Advisory Board has met to review the company’s Phase II data and to advise on the design and execution of late stage, US-based clinical trials of Onyvax-P, the company’s lead product to treat advanced prostate cancer.

Onyvax’s US Advisory Board is chaired by Kenneth Pienta, Professor of Internal Medicine and Urology at the University of Michigan Comprehensive Cancer Center and members include Professor Celestia Higano (University of Washington), Professor Maha Hussain (University of Michigan), Professor Phillip Kantoff (Harvard Medical School), and Professor Nick Vogelzang (Nevada Cancer Institute). Observers to the meeting also included James Gulley (National Cancer Institute), Philip Arlen (National Cancer Institute) and Craig Dionne (Prostate Cancer Foundation).

Professor Pienta said: “Onyvax’s Phase II results are compelling. The fact that 40% patients treated with Onyvax-P showed a statistically significant reduction in PSAV is impressive, particularly as the reduction was sustained over the course of treatment. Furthermore, the median progression free survival of 58 weeks is longer than we would expect from our own clinical experience. There is great demand from US patients for vaccine therapy and I believe that recruitment to the Phase IIb/III program will be rapid. The Advisory Board looks forward to helping Onyvax implement its US clinical strategy.”

Commenting on the meeting, Dr. Anthony Walker, CEO of Onyvax, said: “We were delighted to draw on the expertise of such a prestigous group of clinicians. Following the successful Phase II trials of Onyvax-P we continue to work with the major clinical centers and regulatory authorities to initiate a Phase IIb/III clinical trial that will provide data suitable for worldwide registration of this treatment”

 


For further information, please contact:

Onyvax
Dr Anthony Walker / Robert Johnson
+44 (0)208 682 9494

Financial Dynamics
Julia Philips / Lucy Briggs
+44 (0)20 7831 3113

 


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