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news.Galectin Therapeutics has obtained regulatory approval from the US Food and Drug Administration (FDA) to initiate a first-in-man Phase 1 clinical study of its GR-MD-02 for the treatment of non-alcoholic steatohepatitis (NASH, or fatty liver disease) with advanced fibrosis.
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The start of the trial is based on the the review of GR-MD-02 investigational new drug (IND) application by the US Food and Drug Administration (FDA).
The trial,which will be conducted in up to seven US centers, is entitled as ‘A Multi-Center, Partially Blinded, Maximum Tolerated Multiple Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety of GR-MD-02 in Subjects with Non-Alcoholic Steatohepatitis (NASH) with Advanced Hepatic Fibrosis’.
Galectin Therapeutics president, chief executive officer and chief medical officer Peter Traber said there are currently no approved medical treatments available for patients with NASH and advanced fibrosis.
"This decision by the FDA is an important milestone in our clinical development program to bring forward a treatment option for these patients," Traber added.
"We have recruited a world-class group of clinical investigators and engaged CTI of Cincinnati Ohio, a full service Clinical Research Organization with extensive experience in liver-related clinical trials, to run the operations of the Phase 1 clinical trial."
The company anticipates that the first cohort will be enrolled and infused with the drug in May 2013.