Bavarian Nordic Announces Start of Randomized Phase 2 Study Comparing PROSTVAC® and Chemotherapy versus Chemotherapy
Kvistgård, Denmark, February 28, 2011 - Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a new multicenter, randomized Phase 2 study of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with PROSTVAC®. The study will compare PROSTVAC® followed by docetaxel (chemotherapy) versus docetaxel alone.
Patients in the PROSTVAC® arm will receive an accelerated treatment with PROSTVAC® (5 immunizations over 2 months) followed by docetaxel and prednisone. The control arm will receive upfront docetaxel and prednisone. After completion of study therapy, patients are followed up every 3-6 months for 5 years. With the first patients now being enrolled, the study is anticipated to be fully enrolled with 144 patients in 2012.
The primary endpoint of the study is to evaluate the overall survival. Secondary endpoints include the evaluation of prostate-specific antigen (PSA) response rates and evaluation of the association between development of PSA-specific immune responses, time to progression, and overall survival in patients treated with these regimens.
The study is being conducted by The Eastern Cooperative Oncology Group (ECOG) - one of the largest clinical cancer research organizations in the United States. Dr. Doug McNeel (University of Wisconsin) is the Principle Investigator of the study. The DCTD/NCI-sponsored 1) study is being conducted under the cooperative research and development agreement (CRADA) that Bavarian Nordic has with the NCI for further development of PROSTVAC®.
Anders Hedegaard, President & CEO of Bavarian Nordic said: "We are happy to announce the initiation of this Phase 2 study, Through this and other studies supported by our partner NCI, the potential synergic effects by combining PROSTVAC® with traditional therapies is investigated, offering an extension of our already large clinical data package. Data from another large Phase 2 study with PROSTVAC® has already demonstrated a significant survival benefit for patients with metastatic castration-resistant prostate cancer, and we expect to initiate confirmatory Phase 3 trials under a Special Protocol Assessment agreement with the FDA later this year as previously announced."
1) Division of Cancer Treatment and Diagnosis at National Cancer Institute