Barvarian Nordic announces new Phase II trial of Prostvac in mCRPC

According to a media release from Bavarian Nordic, issued on Monday, the company has initiated a new, randomized, multi-center, Phase II clinical trial of its investigational immunotherapeutic agent, Prostvac®, in men with metastatic, castration-resistant prostate cancer (mCRPC).

Data from an earlier Phase II clinical trial — initially presented at the annual meeting of ASCO in 2009 — has already shown that Prostvac has clinical activity in men with mCRPC. In this new trial, patients will be treated with either Prostvac (given as five immunizations over 2 months) followed by docetaxel and prednisone or with docetaxel and prednisone alone. Patients will be evaluated every 3 to 6 months for up to 5 years.

The study is being conducted by the Eastern Cooperative Oncology Group (ECOG) and is expected to enroll a total of 144 patients by some time in 2012. The first patients are already being enrolled. Detailed information about this study is available on the web site.

The primary endpoint of the new study is overall survival. Additional, secondary endpoints include PSA response rates, time to disease progression, and the association between PSA-specific immune responses, time to progression, and overall survival in patients treated with the two different regimens.

A randomized Phase III clinical trial of Prostvac has also been designed, but this trial has not yet been implemented.

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