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Veru Receives Positive Input from FDA on Phase 3 Pivotal Trial to Evaluate VERU-111 in Metastatic Castration Resistant Prostate Cancer
--Pivotal Phase 3 Clinical Trial Expected to Initiate First Quarter Calendar Year 2021-- MIAMI, July 23, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an
About this update from Veru Inc.
[{"type":"text","content":"--Pivotal Phase 3 Clinical Trial Expected to Initiate First Quarter Calendar Year 2021--\nMIAMI, July 23, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, today announced that it has received regulatory clarity from the U.S. Food and Drug Administration (FDA) on the pivotal Phase 3 trial design for VERU-111—its oral, first-in-class, novel alpha and beta tubulin targeting drug candidate being evaluated for the treatment of metastatic castration and novel androgen-blocking agent resistant prostate cancer. \n “Input from the FDA was very positive and constructive regarding the VERU-111 pivotal Phase 3 trial design. We received clarity that the indication, metastatic castration and novel androgen blocking agent resistant prostate cancer, which is a prechemotherapy population, was acceptable, and that an open label, randomized, active control study using an alternative novel androgen blocking agent as the active control is reasonable, and that the primary endpoint will be radiographic progression-free survival,” said Mitchell Steiner, MD, Chairman, President and CEO of Veru. “By allowing radiographic progression-free survival as an endpoint, the sample size of the Phase 3 study could be much smaller—potentially between 200 and 300 men. We plan to submit the final Phase 3 protocol to FDA in the fourth quarter of calendar year 2020. We plan to also meet with the EMA. We anticipate starting the Phase 3 pivotal study in the first quarter of calendar year 2021.” “The treatment of men with metastatic castration resistant prostate cancer usually involves the use of one or more novel androgen receptor (AR) targeting drugs followed by standard taxane based intravenous chemotherapy. The promising preliminary evidence of safety and efficacy of VERU-111 provides an excellent opportunity for the treatment of metastatic castration resistant prostate cancer clinical paradigm of unmet need,” said Mario Eisenberger, MD, the R. Dale Hughes Professor of Oncology and Urology at the Johns Hopkins Hospital and a Director at Veru. About Veru Inc.Veru Inc. is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. The Veru prostate cancer pipeline inc...