Onyvax Phase IIb Clinical Trial of Prostate
Cancer Vaccine Underway
with the Addition of UK Clinical Centres
Trial Adopted by the UK National Cancer Research Network
London, UK, 11 December 2006: Onyvax Ltd, the biotechnology
company developing novel cancer therapies, today announced that
a Phase IIb clinical trial with Onyvax-P, designed to stimulate
the immune system to fight prostate cancer, is underway with
the addition of UK clinical centres and adoption by the UK’s
National Cancer Research Network (NCRN). This follows the commencement
of the trial in the Baltic States where the first patients have
The trial is the first industry-sponsored protocol to be adopted
by NCRN since the launch of the NHS research strategy “Best
Research for Best Health” which includes enhancing the
environment for contract and collaborative research with industry
as an explicit aim.
The NCRN was established to accelerate patient recruitment into
clinical trials and improve the integration of research into
clinical practice. The NCRN and the Department of Health are
committed to working with pharmaceutical and biotech companies
to identify the most promising leads to new therapies from both
the academic and commercial sectors. Clinical trials are only
selected by NCRN following independent review and adoption of
studies by the network is an assurance of the study’s potential
value to the NHS.
The trial is evaluating a total of 75 patients across Europe
who have non-metastatic, hormone resistant prostate cancer, with
50 patients receiving active therapy and 25 patients receiving
placebo. Patients will receive 15 administrations of vaccine
over 12 months with the aim of maintaining a strong anti-cancer
immune response throughout the treatment period. The primary
endpoint is progression free survival at 12 months and secondary
endpoints include overall survival, median progression free survival,
PSA velocity and immunological responses. Onyvax expects to receive
PSA velocity data and progression free survival data 6 and 12
months after the last patient is enrolled respectively.
Professor Hardev Pandha, the Chief Investigator of the trial,
said: “Patients at this stage of disease are asymptomatic
and a rising level of PSA, the blood marker for prostate cancer,
is the only sign that the disease is progressing. There are no
approved treatment options for these patients. The aim of this
vaccine treatment is to slow down the progression of the disease,
delay the onset of metastases, cancer-related pain and the use
of chemotherapies and at the same time maintain a high overall
quality of life. This would be considered a major clinical advance.”
The Postgraduate Medical School, University of Surrey working
with the St Luke’s Cancer Centre will be the first site
in the UK to open, with others opening over the coming months.
Patients interested in the study should check www.onyvax.com
for the latest information.
The Phase IIa trial for Onyvax-P, published in Clinical Cancer
Research, June 15th 2005 edition, showed:
• mild side effects, typical of vaccines;
• 40% patients showed significant slowing of PSA rise
(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.
For further information:
UK Patients and Clinicians, please contact:
Postgraduate Medical School, University of Surrey/
Chief Investigator: Prof. Hardev Pandha
Tel: 01483 688572
Media/company enquiries, please contact:
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,
entered Phase IIb clinical trials in 2006. 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 also developing Onyvax-105, an antibody based therapy
designed to target CD55. The product has shown promising results
in early clinical trials in colorectal cancer and osteosarcoma.
The company is intending to develop the antibody further, initially
in prostate cancer.
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