PROSTVAC® and Ipilimumab Phase 1 Study Supports Rationale for Combining Two Immunotherapies for Prostate Cancer
KVISTGAARD, Denmark, February 23, 2012 - Bavarian Nordic A/S (OMX: BAVA) announced today that a newly published study suggests potential synergy of the Company's PROSTVAC®investigational therapeutic cancer vaccine when used in combination with ipilimumab, another immune therapy. Results of the Phase 1 dose escalation study were published in the journal The Lancet Oncology. The scientific findings of this Phase 1 potentially provide proof of concept that the combination of an immune checkpoint inhibitor with a therapeutic cancer vaccine is feasible and might enhance the clinical efficacy of the combination treatment. Several other NCI-funded combination studies with PROSTVAC® are currently ongoing.
According to 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), stated in the paper that although the Phase 1 trial was small and non-randomized, the median overall survival of 34.4 months for the 30 patients treated raises the possibility that the combination ipilimumab and PROSTVAC® might result in prolonged overall survival.
"In a randomized placebo-controlled Phase 2 study, PROSTVAC® demonstrated an 8.5-month improvement in median overall survival, in men with mCRPC. Based upon these encouraging results, we recently initiated our pivotal global Phase 3 clinical study PROSPECT," stated Anders Hedegaard, President & CEO of Bavarian Nordic. "To further enhance the potential efficacy of PROSTVAC®, we studied PROSTVAC® in combination with ipilimumab and are encouraged by the observed safety and efficacy profile of the immunotherapeutic combination."