Galectin Therapeutics, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced that following review of its Investigational New Drug (IND) application, the US Food and Drug Administration (FDA) notified the company that it may proceed with a phase I clinical trial. The first-in-man phase I clinical trial will support a proposed indication of GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH, or fatty liver disease) with advanced fibrosis.

"There are currently no approved medical treatments available for patients with NASH and advanced fibrosis. This decision by the FDA is an important milestone in our clinical development programme to bring forward a treatment option for these patients," said Dr Peter G Traber, president, chief executive officer, and chief medical officer of Galectin Therapeutics Inc. "We have recruited a world-class group of clinical investigators and engaged CTI of Cincinnati Ohio, a full service Clinical Research Organisation with extensive experience in liver-related clinical trials, to run the operations of the phase I clinical trial."

The phase I clinical trial is entitled, "A multi-centre, Partially Blinded, Maximum Tolerated Multiple Dose Escalation, phase I 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 up to seven centres in the United States. It is anticipated that the enrollment and infusion of the first cohort will begin in May, 2013. Future communications will outline study sites and investigators, notification of first infusion of patients, and expected milestone timings for the study.

NASH has become a common disease of the liver with the rise in obesity rates. It 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 NASH can develop fibrosis, or scarring of the liver, and it is estimated that as many as 3,000,000 will develop cirrhosis, a severe liver disease where transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the United States.

Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function.