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Clinical Studies

Where we are in our research

In The Clinical Study Pipeline

Leaf’s efforts are to investigate the therapeutic potential and applications of cannabinoids for cancer for both orphan and non-orphan indications.

Leaf’s novel, proprietary cannabinoid research consists of an extensive library of formulas, discovery of novel cannabinoid pharmacology, an intellectual property portfolio, in-house formulation, processing and manufacturing capabilities, and development and regulatory expertise.

Leaf has a very unique position in the cannabis industry.  Advancements of medicines through FDA regulated research for the purposes of development of therapies and continuing education is what sets us apart.

The BRCX formulas rage from BRCX001 to BRCX021 which is comprised of 21 different, novel and unique combinations of cannabinoids that have a specific effect on cancer cells as well as unique pharmacokinetic differences that enhance the performance of cannabinoids in the body. Updates on the progress will be posted in press releases as they become available. 

Cannabinoids have been a hot topic for the use in the treatment of cancers. It will be interesting to see where data leads us. 

Dr. Sarah KattaMedical Director

Less than 5% of Glioblastoma patients survive more than 5 years. We must do better than that.  

Philip Arlen, PhDResearch Director

It is within our reach to significantly change the way cancer is treated today and provide a better, longer life for patients suffering from the disease. Most have no other hope. We are compelled as human beings to investigate every possible treatment option. It is our duty.

Bill FisherCEO

Opening Stage

Anticipated | 160 patients: This phase emphasizes effectiveness. The goal here is to obtain preliminary data on whether the drug actually works in people who have a certain disease or condition. For this controlled trial, patients receiving the drug are compared with similar patients receiving a different treatment – in this case a placebo. Safety continues to be evaluated and short term side effects.

Results

Expected results were greater tumor shrinkage and better patient reported outcome delineated in treatment patients with solid tumors and myeloma’s who used BRCX001, as compared to control treatments of standard of care only. New data is coming in daily.

Whats Next

At the end of Phase 2 is where the FDA and the company discuss how large-scale studies in Phase 3 will be done. Expected completion June 2020.

Market Opportunities

The initial go-to-market effort will focus around 6 gastrointestinal cancer standard of care protocols for which we will gather additional supporting efficacy data through subsequent trial phases.

We see opportunity for significant additional growth opportunities exist beyond our first-phase gastrointestinal focus.