Flavocure, a drug discovery and development company, was granted Orphan frig status to its lead drug candidate, the cannabis flavonoid Caflanon (FBL-03G), by the United States Food and Drug Administration (FDA) , following the successful demonstration of its therapeutic efficacy in tumor progression in animals with pancreatic cancer.
Treating pancreatic cancer with cannabis
Dr. Henry Lowe, Executive Chairman of Flavocure, said: ” We are very pleased to have received Orphan Drug designation from the FDA for Caflanone. This is a significant milestone underscores Flavocure’s successful innovations and drug development program.”
” our investigational New Drug (“IND”) enabling studies have reaffirmed outstanding results and we anticipate commencing with clinical trials in humans in the coming months to address pancreatic cancer.”
” The world required and demands a new standard of care that is both effective and novel for the treatment of this disease. As a recognized leader in this field of drug discovery, we are poised to bring this new standard of care to the world.”
Dr. Ngeh Toyang , CEO, said: ” despite fewer than 200,000 people per year being diagnosed with the disease, pancreatic cancer is the third most common cause of death among cancer patients in tge United States.”
“We are also motivated by the feedback and inquiries from around the world arising from publication of results from our joint Flavocure and Harvard Medical School pre-clinical studies in the frontiers in Oncology Journal.”
Caflanone FBL-03G has been derived from an endemic strain if cannabis sativa found in Jamaica.
Professor Lowe, Adjunct professor, University of Maryland Medical School and University of tge West Indies Medical School, discovered this rare form flavonoid rich phytomedical material.
The flavocure research team developed a proprietary synthesis of the bioactive material., which is now available in commercial quantities for use in human clinical studies. The drug delivery payload has been designed to utilize a nanodrone delivery technology developed by Harvard Medical School for which protocol has been approved by the FDA.
Orphan Drug Designation
The Orphan Drug designation was passed into law by President Ronald Reagan, as the Orphan Drug Act of 1983, to encourage the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments.