Galectin Therapeutics Completes Enrollment of Second Cohort of Phase 1 Trial of GR-MD-02

Galectin Therapeutics

, 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." The trial is titled, "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." Trial design details can be found at http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1. In 2013, Galectin Therapeutics received Fast Track designation from the FDA for this clinical development program. FDA grants Fast Track designation to help expedite review and approval of drugs in development that treat serious or life threatening diseases and fill an unmet medical need. About Fatty Liver Disease with Advanced Fibrosis Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.