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Veru Enrolls First Patient in Phase 2 Clinical Trial of VERU-100, Novel Long-acting GnRH Antagonist Decapeptide Injection Formulation, for the Treatment of Hormone Sensitive Advanced Prostate Cancer
--VERU-100 formulated to address the clinical limitations of currently available androgen deprivation therapy-- --The Phase 2 clinical trial is expected to be
About this update from Veru Inc.
[{"type":"text","content":"--VERU-100 formulated to address the clinical limitations of currently available androgen deprivation therapy-- --The Phase 2 clinical trial is expected to be completed by 2H calendar 2021-- MIAMI, June 10, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced that it has enrolled the first patient in its Phase 2 clinical trial of VERU-100, a novel, proprietary gonadotropin-releasing hormone (GnRH) antagonist decapeptide, three-month subcutaneous depot injection formulation, for the treatment of hormone sensitive advanced prostate cancer. Androgen deprivation therapy, also known as ADT, is currently the mainstay of advanced prostate cancer treatment and is used as a foundation of treatment throughout the course of the disease. Furthermore, ADT is continued even as other endocrine, chemotherapy, or radiation treatments are added or stopped. The ADT market is well-established for advanced prostate cancer and is estimated to be approximately $2.8 billion worldwide. Standard medical practice for urologists and medical oncologists is to administer ADT every 3-4 months which coincides with follow-up office medical visits and ensures maximum compliance with ADT for patients with advanced prostate cancer. Androgen deprivation therapy using a GnRH antagonist is preferred because castration occurs rapidly within a week with no surges or flares in testosterone levels. Testosterone also tends to reach lower levels which may improve tumor control. GnRH antagonist ADT also lowers FSH levels which is thought to be the reason why, in published studies, there are fewer cardiovascular side effects with GnRH antagonists versus GnRH agonists (LUPRON and ELIGARD). Unfortunately, there are no GnRH antagonist depot injection formulations for ADT approved by FDA for treatment beyond a one-month duration. VERU-100 is a novel, proprietary long-acting peptide, 3-month subcutaneous depot formulation injection that does not require a loading dose designed to address these current limitations of commercially available androgen deprivation therapies. VERU-100 Phase 2 Trial Design The Phase 2 clinical trial is an open label, multicenter, dose finding study evaluating the efficacy and safety of subcutaneous injected dos...