MagicMed Industries Inc merger partner Enveric Biosciences Inc (NASDAQ:ENVB) announced that it has received approval from the Israeli Ministry of Health to begin the Phase 1/2 portion of its study of its synthetic cannabidiol (CBD) glioblastoma treatment, EV101.
The study is designed to investigate the safety and efficacy of synthetic CBD when administered alone or in combination with clomiphene, concurrently with the tumor medication 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 Tali Siegal.
"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," Enveric chief medical officer Robert Wilkins said in a statement. "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."
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The Phase 1 portion of the study is intended to first determine the CBD-temozolomide combination's maximum tolerated dose (MTD), the company said. 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.
"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," Enveric CEO David Johnson said.
"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."
MagicMed and Enveric announced their amalgamation deal in May 2021, merging the two companies in an all-stock transaction. Once closing is complete, Magic Med CEO Joseph Tucker will be appointed chief executive officer of the enlarged company and David Johnson will be appointed executive chairman.
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