New advanced prostate cancer drug trial recruits first patient

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The first patient was enrolled in the Phase 2 clinical trial of VERU-100, a treatment for advanced hormone-sensitive prostate cancer, according to Veru Inc., the drug’s maker.

VERU-100 is a new medicine and is a three month subcutaneous depot injection formulation, which means it is an injection given under the skin and is released slowly over time.

The current basis of treatment for advanced prostate cancer is androgen deprivation therapy (ADT), which is usually continued throughout the disease regardless of whether or not the patient has stopped receiving other treatments. ADT with a GnRH antagonist – which is what VERU-100 is – offers a preferable option because castration occurs quickly without surges in testosterone levels, according to a statement. There is currently no FDA approved GnRH antagonist depot formulation for ADT beyond one month.

“I am excited about the clinical development of VERU-100. Although GnRH antagonists are the preferred approach, there is no long-acting injectable alternative, ”said Dr. Ronald Tutrone, President of the William H. Kalhert Endowment for Urological Research and Medical Director , Chesapeake Urology Research Associates, in a statement. “VERU-100 would fill an unmet clinical need and provide the urologist with the opportunity to maintain continuity of care with our patients and maximize adherence to cancer treatment.”

The Phase 2 trial will evaluate the efficacy and safety of VERU-100 in 35 patients with hormone-sensitive advanced prostate cancer.

“We have already reached an agreement with the FDA on the design of the Phase 3 registration trial. It will be an open-label, multi-center study to assess the efficacy and safety of VERU-100 in approximately 100 men with advanced hormone-sensitive prostate cancer and is expected to start by the end of calendar year 2021, ”said Dr. Mitchell Steiner, President, President and CEO of Veru Inc., in a communicated.

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