Flavocure Biotech, Inc. (“Flavocure”), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I, first-in-human clinical study of Caflanone (FBL-03G) for the treatment of pancreatic cancer.
- IND Clearance for a New Class of Therapeutic Prenylated Phenolic Flavone
- Phase I Clinical Trial Expected to Launch in 2023 and Will Evaluate the Safety and Preliminary Antitumor Activity of Caflanone in combination with radiotherapy.
Baltimore, Maryland--(Newsfile Corp. - May 17, 2023) - Flavocure Biotech, Inc. (“Flavocure”), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I, first-in-human clinical study of Caflanone (FBL-03G) for the treatment of pancreatic cancer. Pancreatic Ductal Adenocarcinoma (PDAC) accounts for about 2% of all cancers and is associated with 5% of cancer‐related deaths. Caflanone treatment is combined with radiotherapy (RT) for enhanced efficacy against cancer cells.
“We are thrilled to obtain clearance to advance Caflanone (FBL-03G) into clinical trials and are excited about the prospects of what this new class of therapeutic agent may mean for cancer patients,” said Dr. David G. Brooks, MD, Ph.D., Interim Chief Medical Officer of Flavocure Biotech, Inc. “This is an important milestone for our company, representing our first program to receive FDA clearance to proceed into a clinical trial. This new approach combining radiotherapy with our lead drug candidate, caflanone, leverages our groundbreaking science and has broad potential applicability in many therapeutic areas,” said Dr. Ngeh J. Toyang, Ph.D., Chief Executive Officer and co-Founder of Flavocure Biotech, Inc.
“Receiving IND clearance to advance a molecule from our platform into a Phase I trial in our first indication represents an important milestone as we continue to advance our pipeline,” said Dr. Henry Lowe, Ph.D., Executive Chairman & Founder of Flavocure Biotech, Inc. “Pancreatic cancers are notoriously defiant to current therapies including chemotherapy, radiotherapy and immunotherapy, and we believe that caflanone could be a safe alternative therapeutic option as well. We are excited about the prospects of our novel approach and how it can potentially improve the care for pancreatic cancer patients in this critical context.”
Caflanone has been shown to increase apoptosis and consequentially decrease survival for pancreatic cancer cells treated with varying concentrations of the molecule and radiotherapy in preclinical studies. Caflanone and radiation delivered to pancreatic tumors in mice caused distant tumors, that were not treated, to shrink, indicating probably augmentation of an anti-tumor immune response. The findings demonstrate the potential of this molecule in the treatment of both localized and pancreatic cancer that has metastasized, providing impetus for further clinical translation with a goal of reducing recurrence and improving patient survival.
About Caflanone (FBL-03G)
FBL-03G, a flavonoid is the unnatural isomer of cannflavin B, a metabolite of cannabis. FBL-03G is a non-cannabinoid and is in development for the treatment of pancreatic and other cancers. FBL-03G targets tumor associated macrophages via the inhibition of CSF1‐R. The molecule has also demonstrated potent suppression of KRAS expression, a major mutation in pancreatic cancer and many other tumors. The frequency of KRAS G12D mutation in Pancreatic Cancer patients is >36% and FBL-03G has demonstrated suppression of gene expression of this hard-to-treat cancer gene.
About Flavocure Biotech
Flavocure Biotech Inc. aims to be a leader in transforming natural products into new cures for patients. The company has discovered several promising new drug candidates. In collaboration with some of the most prestigious research institutions in the world, Flavocure is advancing these candidates through preclinical and clinical research. Preliminary data indicate that Flavocure’s drug candidates possess activity against known driver mutations and targets implicated in cancer. Caflanone is Flavocure’s lead drug candidate and received FDA Orphan Drug Designation in 2019 for pancreatic cancer. In addition to pancreatic cancer, Flavocure’s drug candidates have demonstrated activity in a variety of cancers, including glioblastoma (the most aggressive form of brain cancer), acute myeloid leukemia, and multiple myeloma.
For more information, visit www.flavocure.com or follow us on Twitter and LinkedIn
For investor relations or further information please contact
Douglas Liu
Chief Financial Officer
Flavocure Biotech, Inc.
877-766-0366
dgliu@flavocure.com
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