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Enveric Biosciences Announces Approval from Israel's Ministry of Health to Begin its Phase 1/2 Trial of Triple-Combination CBD Treatment for Glioblastoma
Enveric Enters into Clinical Stage Development of Lead Asset, EV101, in Israel with MOH Approval NAPLES, Fla., July 8, 2021 /PRNewswire/ -- Enveric
About this update from Enveric Biosciences, Inc.
[{"type":"text","content":"Enveric Enters into Clinical Stage Development of Lead Asset, EV101, in Israel with MOH Approval\n\n\nNAPLES, Fla., July 8, 2021 /PRNewswire/ -- Enveric Biosciences (NASDAQ: ENVB) (\"Enveric\" or the \"Company\"), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, announced today that the Company has received approval from the Israeli Ministry of Health to begin the Phase 1/2 portion of its study of its lead asset, EV101, designed to investigate the safety and efficacy of synthetic cannabidiol (CBD) when administered alone or in combination with clomiphene, concurrently with temozolomide, to treat patients suffering from recurrent or progressive glioblastoma (GBM). The study will be conducted at the Davidoff Institute of Oncology, Rabin Medical Center, in Israel under Principal Investigator Dr. Tali Siegal. \n\"Glioblastoma is a highly aggressive form of cancer with a very poor overall survival rate, particularly for those with recurrent GBM, which is the target group for this study,\" said Robert Wilkins, M.D., Chief Medical Officer, Enveric Biosciences. \"Our goal with this study is to enhance the existing treatment's efficacy through adding CBD to create a new standard of care, potentially improving and extending glioblastoma patients' quality of life.\" \nThe Phase 1 portion of the study is intended to first determine the CBD-temozolomide combination's maximum tolerated dose (MTD). Clomiphene will then be added to the regimen for up to 24 patients to rule out toxicity. Once all three agents' MTDs are determined, they will then be applied to the Phase 2 portion to determine initial efficacy, where an additional 40 patients are expected to be recruited and randomized into two open-label treatment arms.\nThe study design is as follows:\nArm 1 (combination): Patients will be treated with the MTD determined in the dose-finding phase for pure synthetic CBD oil + temozolomide. Arm 2 (triple combination): Patients will be treated with the MTD determined in the dose-finding phase for pure synthetic CBD oil + temozolomide + clomiphene. All patients will continue treatment for up to 24 months from Day 1 of the therapy unless unacceptable toxicities, patient consent withdrawal or death occur.\"We believe that the Israeli Ministry of Health's approval for this Phas...