mCRPC patients in UK can participate in Phase III trial of Prostvac VF


According to a story in the UK’s Daily Telegraph this morning, the British government has given approval for eligible patients in the UK to participate in the randomized, Phase III trial of Prostvac VF — a new form of immunotherapy being tested in men with metastatic, castration-resistant prostate cancer (mCRPC).

Approval by the government for the use of this investigational drug in the UK was needed because Prostvac therapy is based on a genetically modified  viral delivery system. The clinical research team in the UK therefore needed approval from the Department for Environment, Food  and Rural Affairs, which assesses potential environmental and human health risks for genetically modified products and animals. The government authorities have now determined that the environment risk associated with Prostvac is “minimal.”

About 30 men in the UK can be enrolled into this trial, which will be the first time any patient in the UK is able to participate in a trial of an immunotherapeutic vaccine for the treatment of prostate cancer. Enrollent will be possible at 10 different sites in the UK.

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