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Cancer vaccine trial enrolling patients
Onyvax, a cancer vaccine company founded in 1997 is starting a Phase II
clinical trial with its lead product, OnyvaxP, 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.
OnyvaxP 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, upon which Update reported in
Edition 2 (Back Issues are published on our web site) demonstrated safety and good tolerability,
with no major side effects from the Onyvax vaccine reported.
'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.'
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. 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.
Patients wishing to find out more about the trial can e-mail [email protected]
or phone the Onyvax trial helpline on 020 8682 9131.
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