The first patient was enrolled in a phase 2 clinical trial for the treatment of hormone-sensitive advanced prostate cancer.
The first patient was enrolled in the phase 2 clinical trial of VERU-100, a treatment for hormone-sensitive advanced prostate cancer, according to Veru Inc. the manufacturer of the drug.
VERU-100 is a novel drug and is a three-month subcutaneous depot injection formulation, which means it is an injection administered underneath the skin and releases slowly over time.
The current basis of treatment for advanced prostate cancer is androgen-deprivation therapy (ADT), which is typically continued throughout the course of disease, regardless of whether a 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 flares in testosterone levels, according to a release. There are currently no FDA-approved GnRH antagonist depot injection formulations for ADT beyond a one-month duration.
“I am excited about the clinical development of VERU-100. While GnRH antagonists are the preferred approach, a long-acting injectable alternative does not exist,” said Dr. Ronald Tutrone, Chair, William H. Kalhert Endowment for Urological Research and Medical Director, Chesapeake Urology Research Associates, in a release. “VERU-100 would fill an unmet clinical need and provide an opportunity for the urologist to maintain the continuity of care with our patients and maximize drug compliance for their cancer treatment.”
The phase 2 trial will evaluate the efficacy and safety of VERU-100 in 35 patients with hormone sensitive advance prostate cancer.
“We have already reached FDA agreement on the phase 3 registration trial design. It will be an open label multicenter study to evaluate the efficacy and safety of VERU-100 in approximately 100 men with hormone sensitive advanced prostate cancer and is anticipated to start towards the end of calendar year 2021,” said Dr. Mitchell Steiner, chairman, president and chief executive officer of Veru Inc., in a release.
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