Bavarian Nordic to Report New PROSTVAC® Clinical Data at the American Society of Clinical Oncology Annual Meeting
KVISTGAARD, Denmark, May 18, 2012 - Bavarian Nordic A/S (OMX:BAVA.CO - News) today announced that new interim data from an ongoing, Phase 2 randomized trial of the Company`s PROSTVAC® therapeutic cancer vaccine when used in combination with Quadramet® (samarium-153 EDTMP), a commercially available skeletal-targeted radiopharmaceutical, will be presented as a poster during the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois on June 2, 2012.
Bavarian Nordic`s PROSPECT, a single global, randomized, double-blind, placebo-controlled Phase 3 study of PROSTVAC® in prostate cancer patients with metastatic disease who have failed hormone therapy is also the subject of a "Trials in Progress" abstract, which is designed to provide an opportunity for members of the research community to present ongoing trials, foster collaboration, and discuss correlatives and novel trial designs.
Abstract titles and presentation times are provided below.
-- "Interim analysis of a phase 2 randomized clinical trial of Samarium-153 (Sm-153) with or without PSA-TRICOM vaccine in metastatic castration resistant prostate cancer (mCRPC) after docetaxel", abstract number 2526, Poster Discussion Session, Developmental Therapeutics - Clinical Pharmacology and Immunotherapy from 8:00 AM to 12:00 PM CT on Saturday June 2, 2012.
-- "Prospect: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC®", abstract number TPS4699, General Poster Session, Genitourinary Cancer from 8:00 AM to 12:00 PM CT on Sunday June 3, 2012.
Bavarian Nordic will also be hosting a PROSTVAC® update and reception on Monday, June 4, 2012 in Chicago, Illinois. The principal investigators for the PROSPECT trial, 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), and Philip Kantoff M.D., Professor of Medicine at Harvard Medical School, will be joined by members of the Company`s senior management team to discuss this next-generation prostate cancer vaccine. To register for this event, or for more information, please contact Mette Buhl of Bavarian Nordic via email at [email protected] or by phone at +45 33 28 83 00.
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company`s pipeline targets cancer and infectious diseases, and includes ten development programs. In oncology, the company`s lead program is PROSTVAC®, a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has been tested in nearly 600 patients. In infectious diseases, the company`s lead program is IMVAMUNE®, a third-generation smallpox vaccine candidate that is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. For more information, visit www.bavarian-nordic.com
About Prostate Cancer
Prostate cancer is the most frequently diagnosed cancer in men. The disease affects approximately one in six men and an estimated 600,000 new cases of prostate cancer are expected in the U.S. and Europe during 2012. With an estimated more than 100,000 deaths in 2012, prostate cancer is also the second-leading cause of cancer death in men. Approximately 4 million men are living in the U.S. and Europe today who have been diagnosed with prostate cancer. Sources: American Cancer Society and Evaluate Pharma.
PROSTVAC® is an "off-the-shelf" prime-boost vaccine that sequentially combines two different poxviruses (vaccinia and fowlpox). Administered subcutaneously, it induces a specific, targeted immune response that attacks prostate cancer cells. Conventional chemotherapy currently used to treat prostate cancer has shown limited improvement in OS and is often associated with serious side effects. In contrast, PROSTVAC® has the potential to extend survival with minimal toxicity.
In a large, prospective randomized, double-blind, placebo-controlled Phase 2 study of 125 patients with metastatic prostate cancer, patients in the PROSTVAC® group had a significantly longer median overall survival by 8.5 months compared to the control group (p=0.006). The hazard ratio estimate for overall survival from the study is 0.56 (95% CI 0.37-0.85).
PROSTVAC® is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement with Bavarian Nordic`s U.S.-based subsidiary, BN ImmunoTherapeutics. To date, PROSTVAC® and related PSA containing poxviral vaccines have been investigated in 19 ongoing and completed clinical trials involving more than 850 patients. PROSTVAC® is currently the subject of five NCI sponsored clinical Phase 1 and 2 studies in different settings.
About the PROSPECT Phase 3 Program
The single global, randomized, double-blind, placebo-controlled Phase 3 study is based on the promising findings from a previous randomized, placebo-controlled Phase 2 trial of the vaccine in 125 patients with advanced prostate cancer and is expected to enrol about 1,200 patients in three study arms. Patients in the two active study arms will receive either PROSTVAC® alone or PROSTVAC® with adjuvant doses of GM-CSF. Patients who have metastatic disease and have failed hormone therapy will be eligible to enrol in the study. The primary endpoint is overall survival (OS). For the study outcome to be positive, either one or both of the treatment arms must be superior to placebo. About 300 clinical trial centers in more than 20 countries are expected to participate in the trial. Patient enrolment in the trial is expected to take up to twenty-four months.
For more information about the trial, visit http://www.continueyourfight.com