NORCROSS, Ga., April 23, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that all eight (8) patients have received their first infusion in cohort 2 of its Phase 1 clinical trial of GR-MD-02 in patients with NASH with advanced fibrosis. Patients in cohort 2 were successfully dosed with 4 mg/kg, which is double the dose given in cohort 1. The clinical trial protocol specifies that eight patients are included in cohort 2; however, an additional two patients may be enrolled to ensure the requisite number of eight patients complete the 63-day protocol in the second cohort.
As with all phases of the clinical trial, this cohort was initiated in full compliance with the rules, regulations and specific conditions set forth by the U.S. Food and Drug Administration (FDA) for this Phase 1 clinical trial. The second cohort follows highly successful results from the first cohort showing that 2 mg/kg was safe and very well tolerated, and that GR-MD-02 treatment resulted in significant improvement in multiple biomarkers of fibrosis and liver inflammation in patients with NASH with advanced fibrosis. (see full results at: http://galectintherapeutics.com/wp-content/uploads/2014/03/20140401GT020FirstCohortFINAL.pdf). In addition to serum biomarkers, patients will be evaluated with FibroScan® when available, an FDA-approved ultrasound method for evaluating liver tissue stiffness, to gain experience in this method for evaluating liver fibrosis. The Company anticipates reporting the results of cohort 2 around the end of July 2014.
"We are pleased that enrollment of the second cohort was completed very rapidly, which speaks to the urgent need to identify an effective treatment for fatty liver disease with advanced fibrosis," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "The goal of therapy with GR-MD-02 in NASH patients with advanced fibrosis is the reversal of fibrosis and prevention of complications of cirrhosis and liver transplantation."