Veru Inc. 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. 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. VERU-111 is a novel, proprietary, next generation, first-in-class oral selective antitubulin agent that targets and disrupts alpha and beta tubulin subunits of microtubules. In cancer cells, microtubules are critical for transport of growth factor receptors, cellular proliferation, and metastases. In preclinical effectiveness and toxicity studies, orally administered VERU-111 demonstrated significant antitumor activity against castration and novel androgen blocking agent (abiraterone or enzalutamide) resistant human prostate cancers. Furthermore, VERU-111 had significant antitumor effects against cancers that overexpress multidrug resistant proteins, like P-glycoprotein, a common mechanism by which cancer cells become resistant to cancer drugs. At oral doses that had significant antitumor effects, VERU-111 had a favorable safety profile as it did not cause neutropenia or myelosuppression, common dose limiting side effects of other classes of commercially available antitubulins such as intravenous taxanes or intravenous vinca alkaloids. Veru is conducting an open label Phase1b/2 clinical trial evaluating the safety and effectiveness of VERU-111 in men who have metastatic castration resistant prostate cancer who have also become resistant to novel androgen blocking agents like abiraterone or enzalutamide. In addition to prostate cancer, VERU-111 had antitumor effects in other cancer types including preclinical human models for triple negative breast cancer, ovarian cancer and pancreatic cancer. VERU-111 has the potential to be the first FDA approved selective antitubulin agent that targets and disrupts alpha and beta tubulin subunits of microtubules to treat cancer.