On September 14, 2017 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that an independent Data Monitoring Committee (DMCB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 PROSPECT study of PROSTVAC in patients with metastatic castration-resistant prostate cancer (mCRPC) is futile (Press release, Bavarian Nordic, SEP 14, 2017, View Source [SID1234520525]).
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"We are extremely disappointed for patients that this study of PROSTVAC as monotherapy was not successful," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic. "On behalf of Bavarian Nordic, I want to express our gratitude to the PROSPECT investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of combination treatments, including immunotherapies, to transform the future of cancer therapies."
The contents of this announcement do not affect the Company’s expectations for the financial results for 2017.
About the PROSPECT study
PROSPECT was a global, randomized, double-blind, placebo-controlled Phase 3 study conducted under a Special Protocol Assessment (SPA) from the FDA. The objective of the study was to determine whether PROSTVAC alone or in combination with GM-CSF could prolong overall survival in men with asymptomatic or minimally symptomatic mCRPC. The study enrolled 1,297 patients at more than 200 sites in 15 countries.
About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec, or "rilimogene") is a prostate specific antigen (PSA)-targeted immunotherapy candidate designed to enhance or stimulate the body’s immune response, specifically T cells that will home to and kill prostate cancer cells, altering the course of the disease and improving overall survival of patients with prostate cancer. PROSTVAC employs two poxviruses (vaccinia and fowlpox) in a prime-boost vaccine regimen. A robust data package has been established that includes 19 ongoing or completed clinical studies, comprising more than 2,000 patients, the majority of which have been actively treated with PROSTVAC, which has been generally well-tolerated.
PROSTVAC is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement.