Onyvax Publishes Results Of Phase II Prostate
Cancer Vaccine Showing Significant Steps Towards Delaying Disease
[Published in Clinical Cancer Research, June 15th edition]
London, UK, 17 June 2005: Onyvax Limited, the biotechnology company
developing novel cancer therapies, today announced that a paper
published recently in Clinical Cancer Research [Vol. 11, 4469-4478],
confirms results of the first cohort in a Phase II trial of Onyvax-P,
the company’s investigational immunotherapy, showing that
it may delay progression in hormone resistant prostate cancer
(HRPC) patients. If the effects are repeated in forthcoming randomized
trials, the safety and efficacy of this immunotherapy would make
it a compelling treatment option for men at this stage of the
Prostate cancer is the most common cancer in the United States.
Local therapy (radiotherapy and/or surgery) is potentially curative,
however a large number of men develop recurrent disease which
is treated with hormone therapy. A rising level of PSA (a blood
marker for prostate cancer) during hormone therapy indicates the
disease has developed resistance and it was patients at this stage
who were recruited to the Onyvax clinical trial. According to
the Atlas of Clinical Urology, HRPC patients develop asymptomatic
bone metastases 26 weeks after a rising PSA, symptomatic bone
metastases 17 weeks after that, followed by death 52 weeks later.
The goal of this clinical trial was to delay the onset of metastatic
The results showed that 42% of the treated patients showed statistically
significant, prolonged decreases in their PSA velocity (PSAV)
without experiencing significant toxicity and this is believed
to be the first time this effect has been seen. Onyvax’s
vaccination approach resulted in an extended median time to disease
progression (TTP) of 58 weeks, a large improvement to historical
experience which suggests a median TTP of 26-29 weeks.
Data from the second cohort of patients who had asymptomatic
bone metastases were recently published at the American Society
of Clinical Oncology on 15th May 2005.
Artificial Neural Network (ANN) analysis was used to show that
certain cytokine profiles could predict clinical outcome with
a high degree of accuracy. ANN’s have previously not been
used to associate complex immunological parameters with clinical
responses. If the ANN data is validated then this methodology
will prove useful in the future management of HRPC patients.
Onyvax plans to start Phase IIb/III pivotal clinical trials of
Onyvax-P this year.
For further information, please contact:
Dr Anthony Walker / Robert Johnson
+44 (0)208 682 9494
Julia Philips / Lucy Briggs
+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 of 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 due to enter
Phase IIb/III clinical trials in 2005. 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. The Phase II trial for Onyvax-P was conducted
by the Department of Oncology at St George’s Hospital Medical
School, London, UK.
Onyvax is committed to the commercialisation 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