Barvarian Nordic (BN) released some outstanding news a few days ago. According to BN they hope to complete the enrollment in their phase 3, double blind, randomized, placebo controlled, international clinical trial of their cancer vaccine, Prostvac VF. The trial known as PROSPECT is scheduled to be completed with in the next 12 months, unless it is halted earlier.
Their announcement in the way of a media release confirms that BN has reached an agreement with the U.S. Food & Drug Administration (FDA) regarding a planned interim analyses of the data. This agreement would allow BN to stop the trial early if there is clear evidence of superior efficacy in one of the three arms of the trial.
Prostvac VF, like sipuleucel-T (Provenge), is an immunotherapeutic vaccine. Provenge has already been approved by the FDA is being used in the clinic, but Prostvac VF is still in trial. They both are designed to fill the same market segment, men with metastatic, castration-resistant, chemotherapy-naive prostate cancer. However, Prostvac VF is an “off-the-shelf” form of immunotherapeutic agent that does not require each dose to be individually created for each man as Provenge requires. If approved by the FDA, Prostvac could supplant Provenge as the go to treatment because of its ease of use, however I wonder what could happen if these two treatments are used in conjunction with each other.
Additional information about this trial is available at the Clinical Trials.gov web site. Additional information about the treatment can be seen on this blog by searching for Prostvac in the search box.
Joel T Nowak, M.A., M.S.W.