“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.”
The 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.
The study design is as follows:
“We believe that the Israeli Ministry of Health’s approval for this Phase 1/2 study is a major milestone not only for Enveric but also for glioblastoma patients globally who are seeking to prolong their survival and improve their quality of life,” added David Johnson, Chairman and CEO of Enveric Biosciences. “Our goal is to further demonstrate CBD’s efficacy when combined with current anti-cancer drugs to optimize the existing standard-of-care for cancer patients in need. We are targeting the fourth quarter of 2021 for the enrollment of our first patient, following the conclusion of the final study agreements with the site.”
This product is not approved for marketing anywhere in the world.
About Enveric Biosciences
Enveric Biosciences is a patient-first biotechnology company developing rigorously tested, novel cannabinoid medicines to improve quality of life for cancer patients. Initial indications include radiodermatitis, a common and often severe side effect of radiation therapy, and chemotherapy-induced neuropathy. For more information, please visit https://www.enveric.com/.
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SOURCE Enveric Biosciences