Veru Initiates Phase 2 Clinical Trial of VERU-111, First-in-Class, Oral, Advanced Prostate Cancer Drug

--VERU-111 Targeting Men with Metastatic Castration Resistant Prostate Cancer Who Have Also Become Resistant to Abiraterone or Enzalutamide--

--Phase 2 Study Results Expected by Calendar Year End—

MIAMI, Feb. 26, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), The Prostate Cancer Company, an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, today announced that it has initiated the Phase 2 portion of its ongoing Phase 1b/2 clinical trial for VERU-111, its first-in-class, oral, selective antitubulin proprietary drug for metastatic castration and novel androgen blocking agent resistant prostate cancer.

“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,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.  “The first patient in the Phase 2 study has been dosed representing a key milestone in the clinical development of VERU-111.  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.”

Dr. Steiner added: “VERU-111 is initially targeting men who have metastatic castration resistant prostate cancer (mCRPC) and who have also become resistant to novel androgen blocking agents, such as abiraterone or enzalutamide, but prior to proceeding to IV chemotherapy -- also referred to as the prechemotherapy stage.  This prechemotherapy stage in men is currently one of the fastest growing unmet medical needs in advanced prostate cancer.  We are developing VERU-111 to be the next go to therapy in men with advanced prostate cancer who fail a novel androgen blocking agent.”

The open label, single arm, Phase 2 clinical trial will evaluate the efficacy and safety of VERU-111 in 39 mCRPC patients who have become resistant to a secondary novel androgen blocking agent (abiraterone or enzalutamide).  Enrolled men will receive 63 mg of VERU-111 per day, the dose that was selected based on the Phase 1b portion of the study conducted in 39 men.  Dose increases of VERU-111 up to a dose of 72 mg will be allowed in the study.  In the Phase 1b study, VERU-111 was well tolerated with no reports of neurotoxicity, hypersensitivity (allergic) reactions and febrile neutropenia which are side effects common to intravenous taxane chemotherapy.  The key efficacy endpoints of the Phase 2 study are radiographic imaging of progression-free survival and prostate-specific antigen (PSA) reductions.  Patients will continue to receive VERU-111 until radiographic evidence of prostate cancer progression is observed.