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Veru Completes Enrollment of Phase 2 Clinical Trial of VERU-111, Novel Oral Drug for Metastatic Prostate Cancer
MIAMI, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel
About this update from Veru Inc.
[{"type":"text","content":"MIAMI, Sept. 29, 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 fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for metastatic castration and novel androgen receptor targeting agent resistant prostate cancer. The study enrolled a total of 40 men at 13 clinical sites in the United States.\n The open label, single arm, Phase 2 clinical trial will evaluate the efficacy and safety of VERU-111 in 40 men with metastatic prostate cancer who have become resistant to at least one androgen receptor targeting agent (abiraterone or enzalutamide), but prior to IV chemotherapy in the metastatic setting. Enrolled men will receive 63 mg of VERU-111 per day, the recommended dose selected from the Phase 1b portion of the study which was conducted in 39 men. In the Phase 1b study, VERU-111 63mg oral daily continuous dosing chronic administration was well tolerated with no reports of neurotoxicity, hypersensitivity (allergic) reactions and neutropenia. Promising antitumor activity was also observed in the Phase 1b clinical study with evidence of PSA declines, objective tumor responses, and durable responses. The key efficacy endpoint of the Phase 2 study is radiographic imaging of progression-free survival. “We are excited to have fully enrolled the phase 2 portion of the phase 1b/2 clinical trial evaluating the recommended 63 mg oral daily continuous dosing of VERU-111 for metastatic castration and androgen receptor targeting agent resistant prostate cancer,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “Based on positive clinical results from the Phase 1b portion, which were presented at ESMO on September 18, 2020, as well as the current study results observed thus far from the open label Phase 2 study, we met with FDA in July 2020. With the positive FDA input, we plan to submit the final Phase 3 pivotal registration study to FDA in Q4 2020 and meet with EMA in Q1 2021.” 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 includes VERU-111, VERU...