Flavocure Announces Initiation of IND Enabling Studies for Drug to Treat Pancreatic and Glioblastoma Cancers
Baltimore, Maryland--(Newsfile Corp. - January 16, 2019) - Flavocure Biotech, Inc., announced today that it has initiated Investigational New Drug (IND) enabling studies for its cannabis derived drug, FBL-03G. The studies, which are estimated to cost over $1 million, have been independently sponsored by the company's Executive Vice Chairman, Clark Swanson. The commitment paves the way for Flavocure to attain IND status from the FDA. The effort is expected to be completed within 9 - 12 months, and following the successful completion of the studies and filing of the IND package with the FDA, the company will undertake Phase 1 human clinical trials initially targeting pancreatic cancer.
Flavocure's Chairman, Dr. Henry Lowe, PhD, said, "As a result of Mr. Swanson's continued leadership and commitment to Flavocure, we are rapidly advancing our drug pipeline to FDA approval. Our collaboration on pancreatic cancer with the Dana Farber Cancer Institute at Harvard University Medical School has demonstrated significant findings in our quest to eradicate one of the most deadly and aggressive forms of cancer, being pancreatic cancer." Lowe further commented, "There have been very little advancements in the treatment of this disease, and Flavocure has emerged a proven quantity in the fight against cancer".
A reputable clinical research organization (CRO) with FDA certification has been contracted to carry out the studies which have now commenced. The results of this effort with the FBL-03G molecule targets a patient market growing at 8.1% CAGR and exceeds $2.5 billion annually based on the therapeutic target and implicated cancers.
FBL-03G has also been shown to be active against glioblastoma, a deadly form of brain cancer and other solid tumors. The company intends to further research targeting glioblastoma once additional funding has been secured. The company expects that FBL-03G will be their 2nd FDA designated Orphan Drug. Under the Orphan Drug Act, the designation/approval would grant Flavocure benefit of FDA/EMA sanctioned exclusivity on the drug for 7 years in the United States and 10 years in Europe, respectively, in addition to any patent protections.
Flavocure was granted an FDA Orphan Drug designation in 2017 for their drug targeting Acute Myloid Leukemia (AML). The drug, Creserol, is also derived from cannabis and is in pre-phase 1 studies with significant collaboration from the University of Maryland School of Medicine.
Cannabis has provided a new spectrum for drug discovery and development as demonstrated notably by the most recent FDA approval of Epidiolex for the treatment of seizures in two orphan conditions associated with Dravet syndrome or Lennox-Gastaut syndrome (LGS) in patients aged 2 years or older.
Flavocure is honored to be one of the clear leaders in the development of new cannabis derived pharmaceuticals targeting cancer. As of the date of this press release, Flavocure is privately held but is in preliminary discussions with several investment banks targeting an initial public offering anticipated in the fall 2019 or early 2020.
We seek safe harbor.