Veru initiates Phase 1b/2 clinical trial for VERU-1111
Veru announced that it has initiated and enrolled the first patient in a clinical trial of its proprietary, next generation prostate cancer drug, VERU-111. The open-label Phase 1b/2 clinical trial for VERU-111, a novel oral drug, will be evaluated in men with metastatic refractory prostate cancer that would be given prior to intravenous chemotherapy. "Upon successful completion of this important clinical trial, we will move forward with additional clinical studies including a pivotal Phase 3 trial," commented Mitchell Steiner, M.D., Chairman, President and CEO of Veru. "Based on earlier preclinical studies, VERU-111 should be effective against refractory prostate cancer and have a more favorable safety profile compared to intravenous taxanes. Drugs for advanced prostate cancer currently have over $3 billion in U.S. annual sales. Our preclinical studies also suggest that VERU-111 may be effective as a treatment for breast, ovarian, pancreatic and other prevalent cancers." "The study will be conducted in approximately five centers in the United States, with results expected by the year-end of calendar 2019. In Phase 1b, the dose escalation portion of the study, patients will receive VERU-111 to determine the optimal dose for testing in Phase 2. In Phase 2, VERU-111 will be assessed for the drug's effectiveness in lowering prostate-specific antigen blood levels, the primary endpoint."