Bavarian Nordic A/S announced today that the company has received a letter of concurrence from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 study required for product registration for its product candidate, PROSTVAC®.
PROSTVAC® is a treatment for patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. This agreement reached with the FDA on this SPA means that the Phase 3 study can proceed as designed and, if successful, could form the primary clinical basis of product approval under a Biologics Licence Application.
”We are very pleased with the agreement on the Special Protocol Assessment with FDA. It not only represents a significant milestone in the development of PROSTVAC®, but also marks the key step in the regulatory process before the initiation of the Phase 3 study, anticipated to start enrolment late summer 2011, upon release of clinical trial material. We believe that PROSTVAC® will provide important benefits in survival and quality of life, compared to existing treatments in advanced prostate cancer”, commented Anders Hedegaard, President & CEO of Bavarian Nordic.