The United States Food and Drug Administration has granted a flavonoid of cannabis (Caflanone) the status of the Orphan Drug. It is estimated that within the next few months, the approved Orphan Drug will be used in clinical trials for treating pancreatic cancer. The clinical trials will involve human subjects.
Flavocure is a drug innovation and development company. The company developed the cannabis flavonoid Caflanone (FBL-03G). The U.S. Food and Drug Administration granted Caflanone the Orphan drug status after it was successful in reducing tumor progression in animals with pancreatic cancer through therapy.
The Executive Chairman of Flavocure, Dr. Henry Lowe, said that the company is happy for the designation of Orphan Drug status by the FDA for Caflanone. He further noted that the appointment is a momentous breakthrough for the Flavocure innovation and drug development program.
Dr. Lowe also said that they expect to start a clinical trial involving human subjects with the New Investigational Drug in the next few months. The clinical trials will be addressing pancreatic cancer.
He added that a new standard of care is required for effective and innovative treatment of pancreatic cancer, and as a recognized leader in the field of drug discovery and development, it is their responsibility to bring a new standard of care to the world.
Dr. Ngeh Toyang, the CEO of Flavocure, said that although less than 200,000 people have been diagnosed with pancreatic cancer per year, it is considered as the most common cause of death among cancer patients in the U.S.
Flavocure and the Harvard Medical School conducted pre-clinical studies and published their findings in the Frontiers in Oncology Journal. People from all over the world have been sending feedback and inquiries about the study results, and this has motivated Flavocure to commence the clinical trials for pancreatic cancer.
The drug granted the Orphan Drug status by the FDA, Caflanone, was derived from a prevalent Cannabis Sativa strain found in Jamaica.
Caflanone, which is rich in phytocannabinoids material, was discovered by Professor Lowe, University of Maryland Medical School, and University of the West Indies Medical School.
The Caflanone is now available commercially and can be used in human clinical studies. The Harvard Medical School developed a nano-drone delivery technology for Caflanone, which was approved by the FDA.
Harvard Medical School conducted pre-clinical studies using Caflanone and the drug portrayed great results in animal models with pancreatic cancer, which were difficult to treat. The medical and research community are optimistic about the potential of the drug. It has also aroused the interest of the patients.
President Ronald Reagan approved the Orphan Drug Act in 1983 to encourage companies to innovate and develop drugs that are geared towards helping patients suffering from rare diseases.
Companies which qualify for Orphan Drug designation receive benefit across all stages of drug development such as a speedy approval process, seven years of market exclusivity, and tax credits on U.S. clinical trials. They are also eligible for Orphan Drug grants, and a waiver of some administrative fees.
It is believed that the entire cannabis industry, including players like Marijuana Company of America Inc. (OTCQB: MCOA) and Sproutly Canada Inc. (CSE: SPR) (OTCQB: SRUTF) (FRA: 38G) could be waiting with crossed fingers for the outcome of this planned clinical trial that will expand the confirmed therapeutic benefits of marijuana for cancer patients.
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