Bavarian Nordic A/S (BAVA) announced on November 15, that its subsidiary, BN ImmunoTherapeutics has started the pivotal Phase 3 trial of PROSTVAC® for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. The trial is being conducted under a Special Protocol Assessment agreement with the FDA. Notice this trial has the same criteria as the phase 3 trial of Provenge.
Although there are a number of on-going phase 2 trials, BAVA has now opened their first site in the U.S. for this phase 3 trial. There will be a number of other sites and countries to follow soon.
PROSTVAC® is an “off-the-shelf” therapeutic vaccine candidate that has the potential to extend the lives of people with advanced prostate cancer (according to the data presented from the phase 2 trials). Provenge is the only currently approved cancer vaccine but it is not an “off the shelf” product.
James L. Gulley, M.D., Ph.D., Director of the Clinical Trials Group at the Laboratory of Tumor Immunology and Biology at the National Cancer Institute (NCI), and Philip Kantoff M.D., Professor of Medicine at Harvard Medical School, will act as principal investigators on the trial.
According to Dr. Gulley, the Phase 2 clinical trial data