KVISTGAARD, Denmark, June 2, 2012 - Bavarian Nordic A/S (OMX: BAVA) today announces new interim data from an ongoing, Phase 2 randomized trial of the Company's PROSTVAC® therapeutic prostate cancer vaccine being conducted by the National Cancer Institute (NCI). This trial is evaluating PROSTVAC® when used in combination with Quadramet® (samarium-153 EDTMP, or Sm-153), a commercially available skeletal-targeted radiopharmaceutical. The interim data will be presented as a poster during the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
According to the investigators from NCI, this interim analysis suggests that the combination of PROSTVAC® and Sm-153 in patients with metastatic castration-resistant prostate cancer (mCRPC) is well tolerated with similar toxicity profile to Sm-153 alone. The early indication of improved time-to-tumor progression (TTP) warrants continued study accrual.
"A randomized, placebo-controlled Phase 2 study of PROSTVAC® reported an 8.5-month improvement in median overall survival in men with metastatic, castrate resistant prostate cancer. 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 learn more about the potential usefulness of PROSTVAC® in other settings, PROSTVAC® is being studied by the National Cancer Institute in combination with Sm-153, and we are encouraged by these interim results," he added.
This Phase 2 multi-center trial is intended to randomize 68 patients to Sm-153 alone (Arm A) or with PROSTVAC® (Arm B). Of 37 patients enrolled to date, 3 were not evaluable for progression-free survival (PFS). At four months, the PFS for evaluable patients in Arm A was 11.8% compared to 29.4% in Arm B. Median PFS for patients in Arm A was 60 days compared to 117 days in Arm B. The most common side effects were grade 3 or 4 thrombocytopenia occurring in 22% and 26% of treatment cycles on Arms A and B, respectively. "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" by Gulley, J. et al. (Abstract No. 2526, Poster Discussion Session, Developmental Therapeutics - Clinical Pharmacology and Immunotherapy, 8:00 AM to 12:00 PM CT, Saturday June 2, 2012.)
On Sunday, June 3, 2012, Bavarian Nordic's PROSPECT clinical trial, a global, randomized, double-blind, placebo-controlled Phase 3 trial of PROSTVAC® in prostate cancer patients with asymptomatic or minimally symptomatic, castrate-resistant, metastatic disease will be 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. "Prospect: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC®" by Olga Bandman (Abstract No. TPS4699, General Poster Session, Genitourinary Cancer, 8:00 AM to 12:00 PM CT, Sunday June 3, 2012.
The abstracts can be accessed through the ASCO website, www.asco.org.
Bavarian Nordic also will be hosting a PROSTVAC® clinical update and reception for investors 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 plans for the ongoing clinical development of PROSTVAC®. To register for this event, or for more information, please contact Mette Buhl of Bavarian Nordic via email at email@example.com or by phone at +45 33 28 83 00.
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
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 a prime-boost vaccine that sequentially combines two different poxviruses (vaccinia and fowlpox). Administered subcutaneously, it is designed to induce a specific, targeted immune response that attacks prostate cancer cells. In clinical studies to date, the most common side effects of PROSTVAC® were injection site reactions and fatigue.
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 20 ongoing and completed clinical trials involving more than 2,000 patients.
In April 2010, PROSTVAC® was granted Fast Track designation by the FDA for the treatment of men with mCRPC.
About the PROSPECT Phase 3 Clinical Trial
This global, randomized, double-blind, placebo-controlled Phase 3 trial of PROSTVAC® in men with asymptomatic or minimally symptomatic castrate-resistant, metastatic prostate cancer (mCRPC) 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 are castrate resistant may 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
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. 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 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.
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