June 6, 2013
CTI Clinical Trial and Consulting Services (CTI) announces its collaboration with Galectin Therapeutics on a first-in-man Phase I clinical trial that will support a proposed indication of GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH or fatty liver disease) with advanced fibrosis.
The Phase 1 Clinical Trial is entitled, "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," and will be conducted in six centers in the United States, all of which have extensive experience in conducting liver disease trials. The trial investigator kick-off meeting was held in Atlanta, GA on April 5, 2013, and it is anticipated that the enrollment and infusion of the first cohort will be completed by the end of Q2 2013.
“CTI is excited to be a part of such a groundbreaking clinical trial that will help a significant and progressive unmet medical need,” according to Lynn Fallon, Executive Vice President and President, Consulting at CTI. “NASH affects between 9 and 15 million people in the United States, and is the third leading indication for liver transplantation. This trial will be critical to helping patients where there is currently no approved medical therapy. CTI has extensive experience in liver disease, fibrosis, and in conducting first-in-human trials.”