Bavarian Nordic Agrees On Interim Analysis With The FDA And Provides An Update On Its PROSPECT Phase 3 Trial

KVISTGAARD, Denmark, April 8, 2013 (GLOBE NEWSWIRE) -- Bavarian Nordic A/S (OMX: BAVA) today announced that the Company plans to conduct an interim analysis of the on-going PROSPECT Phase 3 trial of PROSTVAC(r) in prostate cancer patients with metastatic disease. The updated statistical analysis plan for the trial, which was recently accepted by the FDA, now includes pre-specified interim analyses of data that will be performed to evaluate whether the trial should continue as planned or potentially be stopped early for efficacy. In such case, a Biologics License Application may be filed at an earlier stage, potentially shortening the overall development time.

Enrollment in the trial is currently ongoing at almost 100 sites in 10 countries, and continues to expand into new countries and sites. As previously communicated, the initiation of new sites has been delayed due to a lengthier and more arduous regulatory process than anticipated in certain countries. Bavarian Nordic has responded to this delay by implementing a number of measures, aimed at completing enrollment within approximately one year.

Dr. James Breitmeyer, who was recently appointed President of BN Immunotherapeutics, Inc. said, "Enrollment in the PROSPECT study has been my first priority since I joined the company in February. Several enhancements to study conduct have been made to catch up on enrollment. Specifically, we have refocused our efforts towards high-performing clinical trial sites, an awareness program has been implemented, and we have hired additional internal and external resources to allow for a closer dialogue with the increasing number of clinical trial sites."

Two abstracts have been accepted for the American Society of Clinical Oncology (ASCO) Annual Meeting on May 31-June 4, 2013 in Chicago, Illinois, covering clinical safety data for PROSTVAC(r), and the rationale for and design of two new studies of PROSTVAC(r) given in combination with enzalutamide. In connection with the conference, Bavarian Nordic will also be hosting a PROSTVAC(r) update and reception. Further information will follow shortly.