Jay Pharma Inc. (“Jay Pharma” or the “Company”) announced today that it has received institutional review board (“IRB”) approval by Rabin Medical Center in Petah Tikva, Israel for a Phase I/II clinical trial investigating the Company’s proprietary cannabidiol (“CBD”) formulation for the treatment of glioblastoma multiforme (“GBM”), a rare and aggressive form of brain cancer. 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.
The study is expected to enroll 40 patients with recurrent or progressive GBM tumors who are currently undergoing chemotherapy treatments. Half of 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 we look forward to working with Jay Pharma to advance clinical 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. “We are optimistic that this Phase I/II clinical trial will encourage further research with the goal of advancing novel treatment options for glioblastoma.”
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).
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, ” expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. More particularly and without limitation, this news release contains forward-looking statements and information concerning the Amalgamation. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the Amalgamation will be consummated or that the parties other plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific that contribute to the possibility that the predictions, estimates, forecasts, projections and other forward-looking statements will not occur.
The forward-looking statements contained in this press release are made as of the date of this press release. Except as required by law, Jay Pharma disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Additionally, Jay Pharma undertakes no obligation to comment on the expectations of, or statements made by, third parties in respect of the matters discussed above.