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Veru Reports Positive Clinical Results from VERU-111 Phase 1b/2 Trial in Men with Metastatic Castration-Resistant Prostate Cancer, Advancing to Pivotal Phase 3 Clinical Program
--VERU-111 Safe and Well Tolerated at Daily Doses 63 mg and Lower; No Significant Neutropenia or Neurotoxicity Observed-- --Evidence of antitumor activity;
About this update from Veru Inc.
[{"type":"text","content":" --VERU-111 Safe and Well Tolerated at Daily Doses 63 mg and Lower; No Significant Neutropenia or Neurotoxicity Observed--\n --Evidence of antitumor activity; durable PSA declines, objective tumor regression and stable disease-- --In the eight men who have been treated with at least four 21-day continuous cycles, median duration of tumor response without cancer progression is 10 months (range 6-14 months); 7 of these 8 men are still receiving VERU-111 treatment without evidence of cancer progression-- --VERU-111 Phase 2 clinical study portion is enrolling men who have metastatic castration-resistant prostate cancer and who develop prostate cancer progression while on a novel androgen blocking agent, but prior to chemotherapy-- --Company is advancing VERU-111 and plans to meet with FDA next quarter to gain agreement on registration Phase 3 clinical trial design for VERU-111 in this indication-- MIAMI, May 05, 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 provided an update on the clinical results from the fully-enrolled Phase 1b portion of the Phase 1b/2 clinical trial of VERU-111, its first-in-class oral, α and β tubulin inhibitor, in men with metastatic castration-resistant prostate cancer who have become also resistant to a novel androgen blocking agent (abiraterone or enzalutamide). In these men, the androgen receptor targeted approaches have been exhausted. A drug with a different mechanism of action, like VERU-111, is greatly needed for men who have metastatic castration and androgen blocking agent resistant prostate cancer. The Phase 1b portion of the Phase 1b/2 clinical study enrolled 39 subjects from 7 clinical sites in the United States. A standard 3x3 design was used to establish the maximum tolerated dose (MTD), to select a recommended clinical dose for Phase 2 study, and to assess preliminary evidence of antitumor activity of VERU-111 in men with metastatic castration-resistant prostate cancer who have also become resistant to at least one novel androgen blocking agent. There are currently no approved drugs for these men, and the only available therapeutic option is off label IV chemotherapy including taxanes (docetaxel and cabazitaxel). Oral dosing escalated from 4.5mg to 81m...