Zuclomiphene Safely Eases Hot Flashes Linked to ADT Use, Phase 2 Trial Reports

Zuclomiphene Safely Eases Hot Flashes Linked to ADT Use, Phase 2 Trial Reports
Interim Phase 2 trial results show that Veru's experimental treatment zuclomiphene citrate is well-tolerated and significantly reduces hot flashes in advanced prostate cancer patients using androgen deprivation therapy (ADT). These topline findings are from the first 93 men enrolled in the trial (NCT03646162), all of whom were having moderate-to-severe hot flashes caused by ADT treatment. Men given a 50 mg oral dose of zuclomiphene experienced a 41% reduction in those hot flashes at six weeks post-treatment compared to pre-treatment (baseline), a "statistical and clinically meaningful reduction ... without any clinically relevant safety findings," the company reported in a press release. Veru is now planning to open a pivotal Phase 3 trial of zuclomiphene by mid-year. Data from this trial is expected to support a request for zuclomiphene's approval to treat ADT-induced moderate-to-severe hot flashes in men with prostate cancer. “This is an exciting time for Veru. These Phase 2 clinical interim results have established that zuclomiphene has clinically meaningful estrogen activity against moderate to severe hot flashes with a good safety profile, allowing us to advance to a pivotal Phase 3 clinical trial of zuclomiphene,” said Mitchell Steiner, MD, chairman, president and CEO of Veru. ADT is a common hormone treatment for prostate cancer patients, and works by lowering the level of testosterone in the body. But testosterone is needed to produce estrogen in men, which in turn regulates body temperature. Patients undergoing ADT commonly report hot flashes as a severe side effect of the treatment. Brand names for commonly used ADTs to treat advanced prostate cancers include Lupron (leuprolide), Eligard (leuprolide)  and Firmagon (degarelix), Veru rep
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