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Recruitment to the prostate cancer vaccine trial has closed (March 2003)

May 30, 2002

Prostate Cancer Vaccine Trial Set to Expand

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

London, 30 May 2002 - A clinical trial of a novel therapy for prostate cancer at St. George’s Hospital Medical School is being expanded to accommodate a wider range of patients. The study will now enrol 60 prostate cancer patients in a Phase II clinical trial of Onyvax-P, a therapeutic cancer vaccine designed to stimulate patients’ immune systems to specifically attack their cancer.

The Phase II trial is being expanded to include an additional 30 patients who have failed hormone therapy (with rising levels of Prostate Specific Antigen, or PSA, the blood marker of prostate cancer) and who have disease that has spread and can be seen on scans. Recruitment of an earlier trial group of 30 patients who have rising PSA levels but no evidence of disease spread was initiated in January 2002 and is due for completion this summer; clinical results are expected in 2003. All study participants will receive the vaccine therapy for a period of 12 months and will be followed up for a further 12-month period.

Evidence to date suggests that the immune system can selectively identify and attack cancerous cells which carry unique markers. The new vaccine treatment focuses the immune system on these markers with the aim of destroying cancer cells without the severe side effects often associated with conventional cancer treatments.

“New treatments are clearly necessary for prostate cancer, and evidence suggests the disease may be amenable to this immunotherapy approach,” commented Dr Hardev Pandha, lead investigator of the study at St. George’s Hospital Medical School. “We are encouraged by earlier results with similar vaccines, where data suggest the drug was able to generate an immune response against the cancer with an excellent side effect profile. We hope this will translate into improved patient outcome in the current Phase II study and have now expanded our trial in order to be able to be able to monitor and evaluate a broader patient population.”

Prostate cancer appears set to become the most common male cancer within three years; some 21,000 men are diagnosed and 9,500 die annually in the UK. If detected early enough, it can be treated effectively by surgery or radiotherapy while hormone therapy can control later stages of the disease.

A confidential help line has been set up for patients to find out more about potential eligibility for the Onyvax-P trial at 020 8682 9131.

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