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December 11, 2006

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 been treated.

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/
St Luke’s Cancer Centre
Chief Investigator: Prof. Hardev Pandha
Email: clinical.trial@surrey.ac.uk
Tel: 01483 688572

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, 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

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