On August 5, 2019 SFA Therapeutics, Inc. reported 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) (Press release, SFA Therapeutics, AUG 5, 2019, View Source [SID1234538140]).

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"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.