Phase III Trial of Prostvac-VF Is Launched

NEW BRUNSWICK, New Jersey—A new multicenter, randomized, phase III trial of Therion Biologics' Prostvac-VF prostate cancer vaccine is currently underway. The vaccine consists of a virus modified to carry the gene sequence for prostate-specific antigen (PSA) and the transgenes for three T-cell co-stimulatory molecules (TRICOM). It is designed to help the immune system kill prostate cancer cells.

The trial, known as PARADIGM, is led by Robert DiPaola, MD, professor of medicine, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School. It is being conducted in cooperation with the Eastern Cooperative Oncology Group (ECOG) and the National Cancer Institute (NCI).

Eligibility criteria include prostate cancer patients with nonmetastatic, hormone-resistant disease whose PSA increased after local therapy with surgery or radiation therapy. Study participants will receive a series of vaccinations using two different vaccines and GM-CSF, which may enhance the vaccine's effect on the immune system. The primary endpoint is development of measurable disease on scan.

For information on how to participate in the study, individuals should call 732-235-8092.