PHASE IIB CLINICAL TRIAL OF ONYVAX-P IN EARLY STAGE PROSTATE CANCER INITIATED IN UNITED STATES

Trial being funded and conducted by National Cancer Institute, Bethesda, Maryland

London, UK, 26 September 2007: Onyvax Ltd, the biotechnology company developing novel cancer therapies, announced today that a Phase IIb clinical trial with Onyvax-P, designed to stimulate the immune system to fight prostate cancer, is now underway at the National Cancer Institute, Bethesda, Maryland.

The trial, being conducted under Onyvax’s IND, is evaluating a total of 44 patients who have a rising PSA (the blood marker for prostate cancer) after localised therapy of their primary prostate cancer. The trial is a randomised, double blind placebo controlled study with patients receiving three months of Zoladex (a type of androgen deprivation therapy) followed by 15 administrations of vaccine (or placebo) over 12 months. The primary endpoint is PSA-defined progression and secondary endpoints include PSA doubling time, PSA velocity, time to testosterone recovery and immunological responses.

Anthony Walker, CEO at Onyvax, said: “No standard therapy options have been shown to prolong survival for prostate cancer patients with biochemical progression after localised therapy. Many prostate cancer patients eventually receive androgen deprivation therapy (ADT), however this treatment has significant side effects and no well-defined benefit other than reducing PSA. There is evidence to suggest that ADT stimulates the immune system and we are hoping that 3 months of Zoladex will boost the anti-cancer immune response. The aim is to delay the progression of the disease whilst maintaining the patient’s quality of life.”

This new trial at NCI will run in parallel with Onyvax’s existing Phase IIb trial in non-metastatic hormone refractory prostate cancer that is currently recruiting patients across Europe.

A previous study conducted by Onyvax in non-metastatic hormone refractory prostate cancer, 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:

US Patients and Clinicians, please contact:

Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute
Principal Investigator: Dr James Gulley
Email: gulleyj@mail.nih.gov
Tel: (301) 435-2956

Media/company enquiries, please contact:

Onyvax
Dr Anthony Walker / Robert Johnson
+44 (0)208 682 9494

Financial Dynamics
Julia Philips
+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