Onyvax Presents Interim Phase II Data on
its Prostate Cancer Vaccine at the British Cancer Research Meeting
Bournemouth, UK, 3rd July 2003 – Onyvax Ltd (London, UK),
the vaccine therapy company, today presented promising interim
data from its Phase IIa clinical trial in prostate cancer with
Onyvax-P at the British Cancer Research Meeting 2003.
Onyvax reported encouraging findings from the first cohort of
28 patients (out of 48 recruited) in its Phase IIa study of Onyvax-P,
a therapeutic cancer vaccine designed to stimulate the patient’s
immune system to seek and destroy tumour cells.
To date, 20 out of 26 evaluable patients in the trial have shown
no evidence of clinical deterioration, with a median time to
progression of the disease projected at in excess of 48 weeks.
This is anticipated to increase as the data matures.
Data presented by Onyvax show approximately one third of patients
treated with Onyvax-P with a statistically significant decrease
in the rate of Prostate Specific Antigen (PSA) release, the widely
used blood marker that indicates the presence/progression of
prostate cancer. Onyvax also demonstrated a correlation between
apparent disease stabilisation and cytokine responses as a result
of the treatment.
“We are highly encouraged by the findings of this trial
in these seriously ill patients,” said Professor Angus
Dalgleish, Research Director of Onyvax. “The cytokine data
provides strong immunological evidence supporting the efficacy
of the vaccine. Overall, we believe these results, which have
been reviewed by an independent expert panel, justify initiating
randomised trials to confirm the potential extension of progression-free
The clinical study started in January 2002 and has completed
recruitment of 48 patients with prostate cancer who failed hormone
therapy and have rising PSA levels. No approved treatment is
currently available for patients who have failed hormone therapy.
All study participants receive the vaccine therapy for a period
of 12 months and are followed up for a further 12 months. So
far, six patients have completed the treatment period without
any sign of clinical disease progression.
Onyvax-P contains three cell lines that represent different
stages of prostate cancer. The cell lines are irradiated and
so cannot grow or divide. Onyvax designed its vaccine to induce
a powerful immune response against a broad range of prostate
cancer-associated antigens without the severe side effects often
associated with conventional cancer therapies.
In the UK, some 21,000 men are diagnosed with prostate cancer
per year and about 9,500 die of the disease annually. 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 each 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. If detected early enough, prostate cancer
can be treated effectively by surgery or radiotherapy while hormone
therapy can control later stages of the disease. No treatment
is currently available for patients who have failed hormone therapy,
and median survival time for these patients is approximately
Onyvax 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 1997, Onyvax has three product candidates in clinical
trials designed for the treatment 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. 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 standardised
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