Onyvax European Phase IIB Clinical
Trial Completes Enrolment
London, UK – 17 March, 2008: Onyvax Limited, the biotechnology
company developing novel cancer therapies, today announced that
its European Phase IIb clinical trial evaluating Onyvax-P has
completed enrolment. Onyvax-P is the company’s therapeutic
cancer vaccine designed to slow down prostate cancer progression.
Onyvax expects to reach the primary endpoint of progression free
survival in the first half of 2009. If positive, the company plans
to initiate Phase III clinical trials shortly thereafter.
Dr. Anthony Walker, CEO of Onyvax said: "We are grateful
for the tremendous support we received from both the patient and
medical communities for this study and are excited to complete
this important step in the development of Onyvax-P. We look forward
to completing the trial next year, starting Phase III clinical
trials and bringing this cancer vaccine to the market”.
The clinical trial protocol called for a total of 75 evaluable
patients across Europe who have non-metastatic, hormone refractory
prostate cancer, with two-thirds of patients receiving active
therapy and the rest receiving placebo. Patients are receiving
15 administrations of vaccine over 12 months to generate and maintain
a strong anti-cancer immune response throughout the treatment
Previous Phase IIa data for Onyvax-P, published in Clinical Cancer
Research, June 15th 2005 edition, showed:
- mild side effects, typical of vaccines;
- significant slowing of PSA rise in 40% patients (a blood marker
for prostate cancer); and
- on average, time to disease progression (i.e. clinical deterioration)
took 58 weeks compared to historical experience of 29-30 weeks.
Prostate cancer is one of the most prevalent cancers that affects
the male population. Each year approximately 410,000 patients
are diagnosed with the disease in the seven major markets, of
which 250,000 cases are in the United States alone. The incidence
of hormone resistant prostate cancer in the seven major markets
is over 36,500 patients per annum, with a total patient population
For further information:
Dr Anthony Walker / Robert Johnson
+44 (0)208 682 9494
+44 (0)20 7831 3113
Notes to editors
Onyvax Ltd is a biotechnology company developing novel cancer
therapies that harness the selective power of the immune system
to seek and destroy tumour cells.
Founded in 1998, Onyvax is developing products that use the power
of the immune system to treat prostate and other cancers. Onyvax’s
lead products are based on combinations of inactivated cell lines
that induce immune responses to a broad spectrum of tumour targets.
Onyvax-P, a Cell Vaccine for prostate cancer, is the subject of
two randomized, double blind, placebo controlled Phase IIb clinical
trials, one in Europe, the other in US. For each cancer type,
Onyvax generates banks of proprietary cell lines representative
of different stages of the disease. The vaccines are manufactured
in bulk under standardized conditions.
Onyvax is committed to the commercialization of new therapies
that significantly prolong survival while maintaining a high quality
of life for cancer patients. The Company is based in London and
has collaborations with leading institutions in Europe and the
US. Further information on Onyvax can be found at www.onyvax.com