FDA Approval For TroVax® Phase II Study In Prostate Cancer

Aug 6th, 2010 | By healthnews | Category: Health

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 06 Aug 2010 – 8:00 PDT

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Oxford BioMedica plc announces that it has received approval from the US Food and Drug Administration (FDA) and Recombinant DNA Advisory Committee (RAC) to initiate a clinical Phase II study in the United States to assess the activity of TroVax® (MVA-5T4) in patients with progressive hormone refractory prostate cancer (HRPC).

The randomised, open-label Phase II study will enroll 80 patients with metastatic HRPC in five centres across the US and will assess the activity of TroVax® plus chemotherapy drug Docetaxel (Taxotere®), versus Docetaxel alone. The study will be led by Professor Anna Ferrari, NYU Clinical Cancer Center, and is anticipated to be initiated by the end of Q3 2010.

Prostate cancer is the second most common cancer in men worldwide. Prostate cancer hormone therapy involves the removal of the body’s testosterone supply which, for a period of time, will slow or stop the growth and spread of prostate cancer. Hormone refractory prostate cancer occurs when hormone therapy fails to stop the growth of prostate cancer.

John Dawson, Chief Executive Officer at Oxford BioMedica, said:

Receiving FDA and RAC approval is a significant final step in the planning of this study of TroVax® in patients with HRPC and follows positive analysis of the TRIST clinical study. We intend this study to be followed by a series of investigator-led clinical studies and we are pleased to continue the clinical development of TroVax®. With the study design now in place, we look forward to recruiting our first patient and advancing the development of TroVax® in an important disease area.

TroVax® is Oxford BioMedica’s therapeutic cancer vaccine, which is designed to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax® targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a Modified Vaccinia Ankara vector, which delivers the gene for 5T4 and stimulates a patient’s body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4 antigen.

Source: Oxford BioMedica plc

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