Galectin Therapeutics (GALT) Tuesday it has received consent from the U.S. Food and Drug Administration to proceed with a Phase 1 clinical trial for treatment of non-alcoholic steatohepatitis, or NASH, and advanced fibrosis.
NASH is a liver disease characterized by presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol.
The company has recruited a world-class group of clinical investigators and engaged CTI of Cincinnati Ohio, a full service Clinical Research Organization to run the operations of the Phase 1 clinical trial.
The Phase 1 Trial will be conducted in up to seven centers in the U.S., with enrollment and infusion of the first cohort will begin in May. The study will evaluate the Safety of GR-MD-02 in Subjects with NASH and Advanced Hepatic Fibrosis.
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