Baltimore, Maryland–(Newsfile Corp. – October 3, 2019) – Flavocure Biotech, Inc. (“Flavocure”) a drug discovery and development company, announced today that the United States Food and Drug Administration (FDA) on September 25, 2019 granted Orphan drug status to its lead drug candidate, Caflanone (FBL-03G) for the treatment of Pancreatic Cancer.
“We are very pleased to have received Orphan Drug designation from the FDA for Caflanone. This is a significant milestone that underscores Flavocure’s successful innovations and drug development program,” said Dr. Henry Lowe, Executive Chairman of Flavocure. “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 requires 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,” he continued.
Dr. Ngeh Toyang added, “Despite fewer than 200,000 people per year being diagnosed with the disease, pancreatic cancer is the 3rd most common cause of death among cancer patients in the United States. We are also motivated by feedback and inquiries from around the world arising from the publication of results from our joint Flavocure and Harvard Medical School preclinical studies in the Frontiers in Oncology Journal“.
About Orphan Drug Designation
The Orphan designation was passed into law by President Ronald Reagan, as the Orphan Drug Act of 1983, to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases. The designation by the FDA is granted to promote 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. Orphan designation qualifies a company for benefits that apply across all stages of drug development, including an accelerated approval process, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of certain administrative fees.
Caflanone (FBL-03G) has been derived from an endemic strain of Cannabis Sativa found in Jamaica. Professor Lowe, Adjunct Professor, University of Maryland Medical School and University of the West Indies Medical School, discovered this rare form of 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 nano-drone delivery technology developed by Harvard Medical School for which protocol has been approved by the FDA. The drug, in preclinical studies conducted at Harvard Medical School, exhibited powerful results in difficult to treat animal models of pancreatic cancer contributing to clinical optimism in the medical and research community; and, a high level of interest from the patient community.
About Flavocure Biotech Inc
Flavocure Biotech, Inc. (the “Company”) is a private corporation based in Baltimore, Maryland. The company aims to be a leader in the transformation of medicinal properties from natural products into new cures for mankind. The Company has focused on the identification of flavonoid phytochemical properties of cannabis. In collaboration with some of the most prestigious research institutions in the world, the Company discovered scientific breakthroughs in cannabis derived molecules that demonstrate activity against therapeutically validated kinase mutation targets. This led to the company’s success in obtaining an FDA Orphan Drug designation for the drug Cresorol, which has been designated for the treatment of Acute Myeloid Leukemia (“AML”). The Company was recently issued a United States Patent for the treatment of Pancreatic Cancer with their lead drug, Caflanone (known as FBL-03G). The Company is also committed to developing these drugs for the indication of Glioblastoma Multiforme (“GBM”), an aggressive and deadly form of brain cancer.
This news release may contain “forward looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation. All information contained herein that is not historical in nature may constitute forward-looking information. When used in this document, words such as “intends”, “plans”, “anticipates”, “expects” and “scheduled”, are forward-looking statements. Forward-looking statements are subject to a wide range of business, market and economic risks and uncertainties, and although Flavocure believes that the expectations represented by such forward-looking statements are reasonable, there can be no assurance that such expectations will be realized. Any number of factors can cause actual results to differ materially from those in the forward-looking statements. Except as required by law, Flavocure disclaims any obligation to update or revise any forward-looking statements. Readers are cautioned not to put undue reliance on these forward-looking statements.
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