Onyvax Completes Enrolment in
Phase II Clinical Trial in Prostate Cancer
London, UK, 14th April 2003 – Onyvax Ltd, a leading
vaccine therapy company, today announced it has completed patient
recruitment in its Phase IIa clinical trial in prostate cancer.
The study with Onyvax-P was initiated in January 2002 and targets
a total of 48 evaluable patients.
Onyvax P is a therapeutic prostate cancer vaccine designed
to elicit a powerful and specific immune response against prostate
cancer cells without the severe side effects often associated
with conventional cancer therapies. Study participants receive
the vaccine therapy for a period of 12 months and are followed
for a further 12-month period.
Earlier results with an Onyvax prostate cancer vaccine demonstrated
safety and good tolerability with no major side effects reported.
The trial also showed the vaccine was 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.
Onyvax-P consists of three cell lines that are representative of different
stages of the disease and targets a broad range of prostate cancer associated
antigens. The cells have been irradiated so they cannot grow or divide.
“Cancer clinical trials can be extremely difficult to
enrol due to the often strict eligibility requirements, and
we are pleased to announce this milestone in our Phase IIa
Onyvax-P study,” said Anthony Walker, CEO of Onyvax.
Onyvax will be presenting preliminary data from the current
study at the annual meeting of the American Association of
Immunologists in Denver, May 6th-10th. The Company will also
be speaking at Advances in Designing Cancer Vaccines in Boston
on 24th April 2003.
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 per 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. In the UK, some 21,000
men are diagnosed with prostate cancer per year and about 9,500
die of the disease annually. If detected early enough, prostate
cancer can be treated effectively by surgery or radiotherapy
while hormone therapy can control later stages of the disease.
However, no treatment is currently available for patients who
have failed hormone therapy, and median survival time for these
patients is approximately 13 months.