Mitchell Steiner, MD, FACS, Chairman, CEO & President at Veru, A DotCom Magazine Exclusive Interview

Mitchell Steiner, MD, FACS, Chairman, CEO & President at Veru, A DotCom Magazine Exclusive Interview

Mitchell S. Steiner, M.D., F.A.C.S. has served as President and Chief Executive Officer of the Company and as a director of the Company since October 2016. Dr. Steiner was the co-founder of Aspen Park and served as Aspen Park’s Chief Executive Officer, President and Vice Chairman of the Board from July 2014 to October 2016. From 2014 to 2016, Dr. Steiner was a consultant and then the President, Urology and member of senior management of OPKO Health, Inc. (NASDAQ:OPK) and had responsibilities for the launch, marketing, sales and reimbursement of 4Kscore prostate cancer test to urologists and primary care physicians. Dr. Steiner was also the co-founder of GTx, Inc., a men’s health and oncology public company, where he served as Chief Executive Officer and Vice Chairman of Board of Directors from 1997 to 2014. Dr. Steiner is a Board Certified Urologist and a Fellow of the American College of Surgeons and has held numerous academic appointments, including Assistant Professor of Urology, Cell Biology, and Pathology at Vanderbilt School of Medicine from 1993 to 1995 and Chairman and Professor of Urology, Director of Urologic Oncology and Research and the Chair of Excellence in Urologic Oncology at the University of Tennessee from 1995 to 2004. Dr. Steiner holds a B.A. in Molecular Biology and Chemistry from Vanderbilt University and an M.D. from the University of Tennessee. He performed his surgical and urologic training at The Johns Hopkins Hospital and postdoctoral research fellow in cell biology at Vanderbilt School of Medicine.

Veru is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer.Veru is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancers. Our strategy is primarily to focus on the clinical development and commercialization of oncology drugs for the management of two of the most prevalent cancers globally – prostate cancer and breast cancer.

Prostate cancer is the most commonly diagnosed cancer in men with estimated 191,930 new cases and 33,330 deaths expected for 2020 in the U.S. One in nine men will develop prostate cancer in their lifetime. Prostate cancer has new challenges as it develops resistance to current drugs and spreads throughout the body and as the patient suffers from the long-term side effects of prostate cancer treatments like hot flashes, bone loss and fractures, loss of libido, erectile dysfunction, and loss of muscle strength and frailty.

Breast cancer is the most commonly diagnosed cancer in women with estimated 276,480 new cases and 42,170 deaths expected for 2020 in the U.S. One in eight women will develop invasive breast cancer in their lifetime. There are many different types of breast cancer with diverse clinical and molecular characteristics. The most common type is hormone receptor positive where estrogen is one of the main drivers of breast cancer proliferation, tumor progression, and metastasis. Consequently, treatments that target the ER are the mainstay of breast cancer therapy, but unfortunately almost all women will eventually develop resistance to endocrine therapies and alternative treatment approaches will be required including IV chemotherapy. Another form of breast cancer that occurs in 15% of all breast cancers is called triple negative breast cancer. Triple negative breast cancer does not have ER or PR and does not make HER2. As a consequence, it is an endocrine resistant, aggressive cancer that grows and spreads faster than ER+ and/or HER2+ breast cancers. Triple negative breast cancer also develops resistance to currently used chemotherapy drugs like taxanes, and as such, treatment options for TNBC are limited.

We initiated a Phase 1b/2 open label clinical trial of VERU‑111 in metastatic castration resistant and androgen receptor targeting agent resistant prostate cancer patients in January 2019. The Phase 1b study has yielded promising efficacy and safety clinical data. In September 2020, the Phase 2 clinical study completed enrollment of approximately 40 men with metastatic castration resistant prostate cancer who have also become resistant to at least one androgen receptor targeting agent, such as abiraterone, enzalutamide, or apalutamide, but prior to proceeding to IV chemotherapy. The Company anticipates starting the Phase 3 pivotal VERU‑111 VERACITY prostate cancer study in the first quarter of calendar year 2021. The potential U.S. market for oral cancer therapies in advanced prostate cancer is over $5 billion1.

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