Bavarian Nordic Agrees On Interim Analysis With The FDA And Provides An Update On Its PROSPECT Phase 3 Trial
PROSTVAC(r) (PSA-TRICOM) is an off-the-shelf product candidate for the treatment of prostate cancer. In 19 ongoing and completed clinical Phase 1 and Phase 2 trials, more than 600 patients have been treated with the immunotherapy candidate, which has been well-tolerated. PROSTVAC(r) is a 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. The data from a larger Phase 2 trial demonstrated PROSTVAC(r)'s ability to extend the median overall survival of patients with advanced prostate cancer by 8.5 months, a nearly 50% increase compared to the placebo group. This promising data led to the initiation of a confirmatory Phase 3 trial (PROSPECT).
PROSTVAC(r) 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, Inc.
About the PROSPECT Phase 3 ProgramPROSPECT is a single global, randomized, double-blind, placebo-controlled Phase 3 trial and is expected to enroll 1,200 patients in three study arms. Patients in the two active study arms will receive either PROSTVAC(r) alone or PROSTVAC(r) with adjuvant doses of GM-CSF. Patients who have metastatic disease and have failed hormone therapy but who have not yet received other treatment options such as chemotherapy will be eligible to enroll 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 demonstrate a better overall survival than placebo. 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, and includes ten development programs. In oncology, the company's lead program is PROSTVAC(r), 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(r) has been tested in more than 600 patients. In infectious diseases, the company's lead program is IMVAMUNE(r), a non-replicating 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 Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
CONTACT: Anders Hedegaard, President & CEO Phone +45 23 20 30 64
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