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January 9, 2002

Phase II Prostate Cancer Vaccine Initiated

Novel therapeutic vaccine trial to enrol 30 prostate cancer patients at St. George's Hospital Medical School

London, January 09, 2002 Onyvax Ltd, a leading cancer vaccine company, today announced the initiation of a Phase II clinical trial with its lead product, Onyvax-P, in patients with prostate cancer who have failed hormone therapy. The trial will take place at St. George's Hospital Medical School in South London and enrol a total of 30 prostate cancer patients.

Onyvax-P is a therapeutic vaccine designed to provoke the immune system to attack prostate cancer cells. The aim of the vaccine is to prolong survival while maintaining a high overall quality of life for cancer patients.

The Phase II trial will enrol patients on first-line hormone therapy experiencing progressive or breakthrough disease. The study will measure the vaccine's safety, and efficacy, focussing on its ability to improve overall outcome and the quality of life it affords in an outpatient setting. It is an open-label study, and all patients will receive active treatment via monthly injections for a total of 12 months. Patients will then be followed for an additional 12 months.

An earlier Phase I/II trial with an Onyvax prostate cancer vaccine demonstrated safety and good tolerability, with no major side effects reported. That trial also showed the vaccine is capable of producing an immune response against cancer cells, with patients experiencing an increase in cytokine production, antibody response and evidence of T-cell proliferation.

"The limitations of surgery, radiotherapy and hormone treatment for this patient population mean that new therapies are clearly necessary, and evidence suggests the disease may be amenable to immunotherapy," commented Dr Hardev Pandha, lead investigator of the study at St. George's Hospital Medical School. "We are encouraged by earlier results with an Onyvax vaccine, where data suggest the vaccine was able to generate an immune response against the cancer, and we hope this will translate into improved patient outcome in the current Phase II study."

Onyvax-P consists of a combination of three cell lines that are representative of different stages of the disease. The cells have been irradiated and cannot grow or reproduce. Onyvax believes its vaccine will be able to induce a powerful immune response against a broad range of prostate cancer-associated markers.

Prostate cancer is the second most common cause of cancer death among men in the UK, with more than 21,700 new cases reported each year. It is the most common cause of cancer death among American men, with about 198,000 new cases diagnosed each year. In cases where the disease has spread beyond the prostate gland and becomes resistant to hormone therapy, median survival is roughly 13 months. No currently available treatment has been shown to actually prolong life for men whose cancer has reached this advanced stage.

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