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Veru Enrolls First Patient in International Phase 3 ARTEST Clinical Trial of Enobosarm in Metastatic Breast Cancer
-- Enobosarm is a novel targeted hormone drug to be evaluated in the 3rd line treatment of androgen receptor positive metastatic breast cancer -- -- A
About this update from Veru Inc.
[{"type":"text","content":"-- Enobosarm is a novel targeted hormone drug to be evaluated in the 3rd line treatment of androgen receptor positive metastatic breast cancer -- -- A companion diagnostic test will be developed, validated, and used to select patients who are most likely to respond to enobosarm treatment -- -- The Phase 3 ARTEST study will be conducted in 49 clinical sites across the United States and Europe -- MIAMI, Oct. 13, 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 3 ARTEST registration trial of enobosarm, an oral selective androgen receptor (AR) targeting agonist, for patients with AR+ER+HER2- metastatic breast cancer who had tumor progression following treatment with estrogen blocking agents and CDK4/6 inhibitors. “While endocrine therapies have been the mainstay of breast cancer treatment for decades, these therapies have all focused on the estrogen receptor. Targeting the AR, a demonstrated tumor suppressor, provides us with an opportunity to bring a truly novel hormone treatment approach to patients who have AR+ER+HER2- metastatic breast cancer,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. “We already have substantial safety information about enobosarm therapy as it has been evaluated in 25 clinical trials comprising over 2,000 patients with approximately 350 patients dosed at 9mg or higher doses. Enobosarm is well tolerated and has also resulted in improvements in quality of life including reported better physical function, mobility, and pain in metastatic breast cancer patients. Furthermore, a recent Phase 2 study in heavily pretreated patients with metastatic breast cancer confirmed that enobosarm’s efficacy was best in women that had 40% or greater expression of the androgen receptor in their breast cancer.” “Targeting patients expressing the androgen receptor allows us to focus a new endocrine approach on patients that have become resistant to existing therapies,” said Adam Brufsky, M.D., Ph.D., Professor of Medicine, Associate Chief, Division of Hematology/Oncology and Co-Director, Comprehensive Breast Cancer Center at the University of Pittsburgh Medical Center. Dr. Brufsky is also...