On June 2, 2020 AMERI Holdings, Inc. (NASDAQ: AMRH) (the "Company"), reported that its proposed amalgamation partner Jay Pharma Inc. ("Jay Pharma") received institutional review board ("IRB") approval by Rabin Medical Center in Petah Tikva, Israel for a Phase I/II clinical trial investigating Jay Pharma’s proprietary cannabidiol ("CBD") formulation for the treatment of glioblastoma multiforme ("GBM"), a rare and aggressive form of brain cancer (Press release, AMERI Holdings, JUN 2, 2020, View Source [SID1234560775]). This open-label, two-arm, randomized, prospective study is scheduled to commence following final approval from the Israel Ministry of Health, which is expected this summer.
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The study is expected to enroll 40 patients with recurrent or progressive GBM tumors who are currently undergoing chemotherapy treatments. Half the patients are expected to be treated with Jay Pharma’s orally administered synthetic CBD derived from citrus, and half will be treated with CBD in combination with clomiphene, an estrogen binding site inhibitor. This combination has shown promise in cancer treatment studies according to Dr. Zvi Vogel, Professor of Neurobiology at the Weizmann Institute of Science. Dr. Vogel stated, "our initial work with CBD in combination with clomiphene has shown promise and look forward to working with Jay Pharma on combination therapy studies, with the ultimate goal of delivering FDA-approved combination therapies to cancer patients."
The study is expected to be led by Tali Siegal, M.D., director of the Rabin Medical Center’s neuro-oncology center and a clinical advisor to Jay Pharma. Dr. Siegal is also a professor of neurology (neuro-oncology) at Hebrew University & Hadassah Medical School in Jerusalem, chair of the Israeli Neuro-Oncology Forum and serves on numerous scientific committees around the globe.
"We believe that this clinical trial will further advance our understanding into how CBD affects this aggressive, rare and deadly cancer," said Dave Johnson, CEO and Chairman-elect of Jay Pharma. "Our focus on cannabinoid medicine is driven by our belief in its potential efficacy in palliative cancer care and the potential of our proprietary cannabinoid formulation.
"GBM highly expresses the CB2 cannabinoid receptor, and our hypothesis is that CBD ‘opens up’ cell pathways and makes them more susceptible to chemotherapy. As prior studies have shown much promise, we are optimistic this Phase I/II clinical trial will encourage further research with the goal of adding a new treatment for those living with glioblastoma," Mr. Johnson said.
One study published in 2018 demonstrated that 92% of patients with solid tumors responded positively to CBD treatment, showing reductions in circulating tumor cells and reduction in tumor size. Additional studies indicated that CBD may reduce the growth and survival of GBM cell lines, causing cell cycle arrest and inducing cell death (apoptosis).