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Veru Announces Full Enrollment of Phase 2 Trial in Men with Prostate Cancer Treatment Induced Hot Flashes
-- Potential to be First FDA-Approved Drug for ADT induced Hot Flashes – -- Topline Clinical Data Anticipated Fall 2019 -- MIAMI, Oct. 02, 2019 (GLOBE
About this update from Veru Inc.
[{"type":"text","content":"-- Potential to be First FDA-Approved Drug for ADT induced Hot Flashes –\n -- Topline Clinical Data Anticipated Fall 2019 -- MIAMI, Oct. 02, 2019 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), The Prostate Cancer Company, an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer treatment and supportive care, today announced that it has achieved full enrollment for its Phase 2 clinical study of zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist for the treatment of androgen deprivation hormone therapy (ADT) induced hot flashes in men who have advanced prostate cancer. “Our proprietary zuclomiphene citrate product has the potential to be the first FDA-approved treatment for this most common and debilitating side effect of ADT as hot flashes occur in up to 80% of men,”* said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “Hot flashes induced by ADT can be so severe as to cause delay or early discontinuation of ADT.” The Phase 2 clinical study is a double-blind randomized placebo-controlled dose finding study evaluating two doses of oral daily zuclomiphene (10mg or 50mg) treatment versus placebo in approximately 95 men with advanced prostate cancer who have ADT induced moderate to severe hot flashes. The clinical study has a treatment duration of 12 weeks and is being conducted in 24 clinical centers in the United States. The primary endpoint is the frequency of moderate to severe hot flashes. Secondary endpoints include severity of hot flashes and improvement in bone markers. “We are very pleased to have achieved this important enrollment milestone. We look forward to seeing the topline efficacy results and safety data from this Phase 2 trial in the Fall of 2019,” said Dr. Steiner. \"We remain on track for initiation of the Phase 3 clinical study in early 2020. Based on Independent market research sponsored by the Company, US peak sales for zuclomiphene citrate are estimated to be approximately $600 million per year.” About Hot Flashes in Men with Prostate Cancer Undergoing Hormonal TherapyADT is widely used to treat men with advanced prostate cancer. Approximately 600,000 men in the US are currently on ADT, which includes but is not limited to, Lupron®, Eligard® and Firmagon®. The symptom of hot flashes is the most common side effect of ADT. ...