Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced details today on its first-in-man Phase 1 clinical trial that will support a proposed indication of GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH, or fatty liver disease) with advanced fibrosis. The Phase 1 Clinical Trial is entitled, "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" and will be conducted in six centers in the United States which have extensive experience in conducting clinical trials in liver disease.
"We are delighted to have recruited world class US investigators in NASH to conduct this initial study in our development program to treat liver fibrosis associated with fatty liver," said Dr. Peter G. Traber , President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "The clinical trial will be conducted in patients with NASH and advanced fibrosis who will receive four weekly doses of GR-MD-02 and, while evaluation for safety is the primary objective, a series of biomarkers will be evaluated to assess for early signs of efficacy. Therefore, we anticipate obtaining more data from this study than the typical Phase 1 clinical trial."
The clinical trial investigator kick-off meeting was held in Atlanta GA on April 5 2013, led by Galectin and CTI Clinical Trials & Consulting Services Inc of Cincinnati Ohio, a full service clinical research organization with extensive experience in liver-related clinical trials. The investigators and sites that will conduct the study include: Dr. Stephen Harrison of the Brooke Army Medical Center at Fort Sam Houston in San Antonio TX, Dr. Naga Chalasani of Indiana University School of Medicine in Indianapolis IN, Dr. Brent Tetri of St. Louis University School of Medicine in St. Louis MO, Dr. Arun Sanyal of Virginia Commonwealth University School of Medicine in Richmond VA, Dr. Ram Subramanian of Emory University School of Medicine in Atlanta GA, and Dr. Thomas Schiano of Icahn School of Medicine at Mount Sinai in New York City. It is anticipated that the enrollment and infusion of the first cohort will be completed by the end of Q2 2013.
The study is planned to enroll the first cohort followed by potential sequential cohorts receiving increasing doses of GR-MD-02 with eight patients in each cohort randomized 6:2 (study drug:placebo); the patients and medical staff will be blinded to whether the patient is receiving drug or placebo. After the safety of the first dose is assessed, the patients will receive three additional doses weekly doses of GR-MD-02. The dose will be increased after assessment of each cohort to presumptive target therapeutic levels which is currently projected to take one year from the start of the study. In addition to patient safety and GR-MD-02 pharmacokinetics, each patient will have assessment of over two dozen biomarkers of NASH and fibrosis to evaluate for an early indication of drug effect.
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