Clinical trials of Trovax vaccine include a small Phase II trial for prostate cancer, which began in Texas in 2006. This trial was designed for:

* Hormone-refractory prostate cancer
* TroVax administered either as a single agent or in combination with GM-CSF
* Recruitment was completed in July 2006
* To date 85% of patients treated with TroVax mounted an immune response

This Phase II trial in prostate cancer ran at the Methodist Hospital in Houston with Dr Robert Amato as principal investigator. The trial was designed to enroll 24 men with hormone-refractory prostate cancer who had previously received chemotherapy or had refused chemotherapy and had progressive disease. The trial was open label with two arms (12 patients each) to assess the activity of TroVax alone versus TroVax alongside an approved treatment for prostate cancer, granulocyte macrophage-colony stimulating factor (GM-CSF).

The primary objectives of the trial are to evaluate the safety and synergies of the combination treatment, and to assess whether GM-CSF, which is known to increase white blood cell count and hence boost the immune system, increases the anti-cancer immune response stimulated by TroVax. Efficacy endpoints include objective response rate, progression-free survival, overall survival and changes in prostate-specific antigen (PSA) level, which is a recognised marker of disease status.

Oxford BioMedica’s Chief Medical Officer, Dr Mike McDonald, said in 2006: “We are delighted that Dr Amato is supporting a Phase II trial of TroVax in prostate cancer. Given what we know of the product’s safety profile and the anti-cancer immune response that it stimulates, we are hopeful that TroVax can provide a new therapeutic option for patients with prostate cancer who have progressed despite hormone therapy and for whom there are few available treatments.”

Oxford BioMedica (LSE: OXB) said that according to Datamonitor, “treatments for prostate cancer generated worldwide sales of $2.7 billion in 2004.”

Links
LEADING US CLINICIAN TO PRESENT ON OXFORD BIOMEDICA’S TROVAX® AT CANCER CONFERENCE

Principal Investigator for TroVax Phase II trials to present at Cancer Immunotherapuetics & Vaccines meeting on 22-23 August 2006