NORCROSS, Ga., April 17, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that the first patient in cohort 2 of its Phase 1 clinical trial of GR-MD-02 in patients with NASH with advanced fibrosis has been successfully dosed with 4 mg/kg, which is double the dose given in cohort 1. Cohort 2, as with all phases of the clinical trial, 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: http://galectintherapeutics.com/wp-content/uploads/2014/03/20140401GT020FirstCohortFINAL.pdf). The remaining patients in cohort 2 are expected to be enrolled over the next few weeks and we anticipate reporting the results of cohort 2 around the end of July.
"We were extremely pleased with the results of the first cohort, which demonstrated significant biomarker effects on fibrosis and inflammation in all the patients treated with GR-MD-02, coupled with good safety and tolerability," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "These positive results have propelled the enrollment of the second cohort with strong participation across our clinical trial sites. We anticipate the cohort 2 results will further support the use of GR-MD-02 in patients with NASH and advanced fibrosis, with the goal of reversing fibrosis and preventing 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.