On October 28, 2019 SFA Therapeutics, Inc. reported that FDA has granted an official Orphan Drug Designation (ODD) to SFA001, the company’s novel human-microbiome-based treatment for human hepatocellular carcinoma (HCC) (Press release, SFA Therapeutics, OCT 28, 2019, View Source [SID1234549943]).

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"By granting an Orphan Drug Designation to SFA001, FDA has given a special status to treatment of the most prevalent form of liver cancer. This ODD designation will provide SFA Therapeutics with significant drug development and tax advantages as well as an expanded period of market exclusivity," stated Ira Spector, PhD, SFA Therapeutics’ CEO. "These advantages undoubtedly will speed the drug’s availability for a disease that kills hundreds of thousands of patients annually world-wide."

While hepatocellular carcinoma afflicts 54,000 patients a year in the US (Cancer.net), the World Health Organization estimates the disease causes as many as 880,000 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 blocked the progression of hepatitis B to hepatocellular carcinoma and demonstrated a non-chemotoxic mechanism of action in two different animal models of HCC.