SFA Therapeutics, Inc. Requests FDA Orphan Drug Designation (ODD) for SFA001 for Treatment of Hepatocellular Carcinoma (HCC)

PHILADELPHIA–(BUSINESS WIRE)–#Fibrosis–SFA Therapeutics, Inc. announced today that the company has filed an FDA application requesting Orphan Drug Designation (ODD) for SFA001, the company’s novel microbiome-based treatment for human hepatocellular carcinoma (HCC).

“In seeking Orphan Drug Designation (ODD) for this patented new human-microbiome-based drug, we are asking FDA to grant special status to the treatment of the most prevalent form of liver cancer. ODD status would provide significant drug development and tax advantages as well as expanded market exclusivity,” stated Ira Spector, PhD, SFA Therapeutics’ CEO. “These advantages would undoubtedly speed the drug’s availability for a disease that kills hundreds of thousands of patients annually world-wide and has a low survival rate.”

While hepatocellular carcinoma afflicts 54,000 patients per year in the US (Cancer.net), the World Health Organization estimates the disease causes as many as 700,000 deaths per year globally –especially in China and other parts of Asia. SFA Therapeutics has already been granted two patents recognizing the uniqueness of SFA001 treatment. In validated transgenic HBX animal models, SFA001 has been shown to block the progression of hepatitis B to HCC and has been shown to treat HCC with a non-chemotoxic mechanism in two forms of human HCC.

About SFA Therapeutics

SFA Therapeutics, Inc. is a bio-pharmaceutical company focused on new human-microbiome-based advancements in the treatment of inflammatory diseases, targeting NF-kB. Chronic inflammation has been implicated in a wide range of diseases, including HCC, Psoriatic Arthritis, Rheumatoid Arthritis, Lupus (SLE), Inflammatory Bowel Disease (IBD), Crohn’s Disease, Liver Disease and relapse/recurrence in AML and CML.

SFA’s small-molecule drugs are derived from natural substances produced in the human microbiome and enable a new platform for developing safer treatments for inflammatory diseases. SFA001 has been licensed by Temple University to SFA Therapeutics in Jenkintown, PA. Please visit www.sfatherapeutics.com to learn more.

Contacts

Josh Weinstein

jwEinstein Strategic Messaging, Inc.

610.438.8853

[email protected]

Dr. Ira Spector, CEO

SFA Therapeutics, Inc.

267.584.1080

[email protected]