Archived Press Releases
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
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.
Helpline for patients: 020 8682 9131