Veru Completes Enrollment for Second Part of Phase 1/2 VERU-111 Trial

Veru Completes Enrollment for Second Part of Phase 1/2  VERU-111 Trial
Veru has completed enrollment for the second portion of a Phase 1/2 study of VERU-111, its investigational therapy for men with metastatic castration-resistant prostate cancer (mCRPC) who failed to respond to treatment with a new androgen receptor inhibitor. The open-label Phase 1/2 trial (NCT03752099) will evaluate the compound’s safety and efficacy in 40 men with mCRPC at 13 clinical sites across the U.S., including multiple centers in Texas and Maryland. All study participants have mCRPC that has grown resistant to at least one form of hormone therapy, such as Zytiga (abiraterone acetate) or Xtandi (enzalutamide), but who have not yet begun intravenous (into-the-vein) chemotherapy. Both Zytiga and Xtandi target and block the activity of the androgen receptor, preventing it from interacting with male hormones that promote prostate cancer cells’ survival. Men enrolled in the trial will receive 63 mg of VERU-111 per day, which was established as the optimal dose in the first portion of the study. The first patient participating in the second portion of the trial was dosed in March. The main goal of this portion of the study is to determine the time patients live without showing signs of disease progression, which will be evaluated by radiographic imaging. Additional goals include determining the proportion of patients who respond to treatment, and the percentage of those who see their prostate-specific antigen (PSA; a marker of prostate cancer) levels drop by at least 50% from the study’s start. The incidence and severity of adverse events, or undesirable side effects, also will be assessed. “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 o
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