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July 3, 2003

Onyvax Presents Interim Phase II Data on its Prostate Cancer Vaccine at the British Cancer Research Meeting

Bournemouth, UK, 3rd July 2003 – Onyvax Ltd (London, UK), the vaccine therapy company, today presented promising interim data from its Phase IIa clinical trial in prostate cancer with Onyvax-P at the British Cancer Research Meeting 2003.

Onyvax reported encouraging findings from the first cohort of 28 patients (out of 48 recruited) in its Phase IIa study of Onyvax-P, a therapeutic cancer vaccine designed to stimulate the patient’s immune system to seek and destroy tumour cells.

To date, 20 out of 26 evaluable patients in the trial have shown no evidence of clinical deterioration, with a median time to progression of the disease projected at in excess of 48 weeks. This is anticipated to increase as the data matures.

Data presented by Onyvax show approximately one third of patients treated with Onyvax-P with a statistically significant decrease in the rate of Prostate Specific Antigen (PSA) release, the widely used blood marker that indicates the presence/progression of prostate cancer. Onyvax also demonstrated a correlation between apparent disease stabilisation and cytokine responses as a result of the treatment.

“We are highly encouraged by the findings of this trial in these seriously ill patients,” said Professor Angus Dalgleish, Research Director of Onyvax. “The cytokine data provides strong immunological evidence supporting the efficacy of the vaccine. Overall, we believe these results, which have been reviewed by an independent expert panel, justify initiating randomised trials to confirm the potential extension of progression-free survival.”

The clinical study started in January 2002 and has completed recruitment of 48 patients with prostate cancer who failed hormone therapy and have rising PSA levels. No approved treatment is currently available for patients who have failed hormone therapy. All study participants receive the vaccine therapy for a period of 12 months and are followed up for a further 12 months. So far, six patients have completed the treatment period without any sign of clinical disease progression.

Onyvax-P contains three cell lines that represent different stages of prostate cancer. The cell lines are irradiated and so cannot grow or divide. Onyvax designed its vaccine to induce a powerful immune response against a broad range of prostate cancer-associated antigens without the severe side effects often associated with conventional cancer therapies.

In the UK, some 21,000 men are diagnosed with prostate cancer per year and about 9,500 die of the disease annually. According to the American Cancer Society, prostate cancer is the most common cancer among men in the US, with an estimated 220,900 new cases diagnosed each year. It is the second leading cause of cancer death in American men, with about 28,900 deaths per year, exceeded only by lung cancer. If detected early enough, prostate cancer can be treated effectively by surgery or radiotherapy while hormone therapy can control later stages of the disease. No treatment is currently available for patients who have failed hormone therapy, and median survival time for these patients is approximately 56 weeks.

 

About Onyvax

Onyvax is a biotechnology company developing novel cancer therapies that harness the selective power of the immune system to seek and destroy tumour cells.

Founded in 1997, Onyvax has three product candidates in clinical trials designed for the treatment of prostate and other cancers. Onyvax’s lead products are based on combinations of inactivated cell lines that induce immune responses to a broad spectrum of tumour targets. For each cancer type, Onyvax generates banks of proprietary cell lines representative of different stages of the disease. The vaccines are manufactured in bulk under standardised conditions.

Onyvax is committed to the commercialisation of new therapies that significantly prolong survival while maintaining a high quality of life for cancer patients. The Company is based in London and has collaborations with leading institutions in Europe and the US.

Further information on Onyvax can be found at www.onyvax.com

 

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