Jay Pharma Announces IRB Approval for Testing Proprietary CBD Formulation in Glioblastoma Multiforme (GBM)

June 02, 2020

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).

About Jay Pharma

Jay Pharma is dedicated to developing innovative, evidence-based medicines and combination therapies to address unmet needs in cancer care. Our mission is to improve the lives of patients suffering from cancer, initially by developing products for people dealing with the side effects of cancer and cancer treatments, and longer term by advancing a pipeline of novel combination therapies as an adjunct to standard of care cancer treatments.

Forward-Looking Statements

This press release contains certain “forward-looking statements”. Forward-looking statements are based on management’s estimates, assumptions, and projections, and are subject to uncertainties, many of which are beyond the control of Jay Pharma. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that potential products that appear promising to Jay Pharma cannot be shown to be efficacious or safe in subsequent preclinical or clinical trials, Jay Pharma will be not be able to obtain market adoption of its products, Jay Pharma will not obtain appropriate or necessary governmental approvals to market these or other potential products, Jay Pharma may not be able to obtain anticipated funding for its development projects or other needed funding, and Jay Pharma may not be able to secure or enforce adequate legal protection, including patent protection, for its products. All forward-looking statements included in this press release are made only as of the date of this press release, and Jay Pharma does not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

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