NORCROSS, Ga., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that patient enrollment in the first cohort of a Phase 1 trial of GR-MD-02 is now complete. The first-in-man study, which has successfully enrolled eight patients in the first cohort, is evaluating the safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease (NASH) with advanced fibrosis. Intervention in NASH patients with advanced fibrosis, with the intent of reversing the fibrosis, is a potentially important therapeutic approach in this unmet medical need.
The Phase 1 multi-center, partially-blinded clinical trial will be conducted in a total of 24 patients who will receive four weekly doses of GR-MD-02. Each of the three cohorts consists of eight patients, six randomized to receive active drug and two randomized to receive placebo. The study is being conducted at six U.S. centers with extensive experience in clinical trials in liver disease. Two additional centers have been added to aid in the prompt enrollment of the next cohort.
"Completion of enrollment in the first cohort is an important step toward Galectin Therapeutics' objective of bringing a first-in-class treatment to the millions of Americans suffering from fatty liver disease with advanced fibrosis," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "To date, we have seen no serious adverse events in the trial. Following the 70 day study period and analysis of the data, we anticipate that initial safety and tolerability results, as well as biomarkers to evaluate for potential disease effect, from the first cohort will be available around the end of the first quarter of this year."