Veru Advances Prostate Cancer Therapy VERU-111 to Phase 2 Portion of Trial

Veru Advances Prostate Cancer Therapy VERU-111 to Phase 2 Portion of Trial
Veru said it initiated the Phase 2 portion of a clinical trial testing the safety and effectiveness of its investigational therapy, VERU-111, in men with metastatic castration-resistant prostate cancer (mCRPC) who failed to respond to a novel androgen receptor inhibitor. The announcement comes after the Phase 1b part of the trial, a dose-escalation study in 39 patients, showed positive safety and activity results and identified the optimal dose of VERU-111 for this prostate cancer population. The Phase 2 part, which has dosed its first patient, will continue to study the safety and efficacy of this dose. The Phase 1b/2 clinical trial (NCT03752099) is recruiting participants at multiple sites in the United States. “Having seen both preliminary evidence of prostate cancer antitumor activity and an acceptable safety profile in the Phase 1b portion of the clinical trial, we are very excited to now be able to advance VERU-111 into the Phase 2 portion of the clinical trial,” Mitchell Steiner, MD, chairman, president and chief executive officer of Veru, said in a press release. “The first patient in the Phase 2 study has been dosed, representing a key milestone in the clinical development of VERU-111," Steiner said. "We expect results from this Phase 2 study by the end of the current calendar year." "Moreover, since the study is open label, we anticipate being able to update investors periodically as to progress being made in the trial," he said. VERU-111 is a first-in-class oral agent that targets tubulin, a component of microtubules, disrupting these structures. Microtubules are dynamic structures that form part of the cell's cytoskeleton, providing shape to cells and helping them move and divide. Some chemotherapies, called taxanes —including J
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