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First Cohort Results In Galectin Therapeutics' Phase 1 Trial Reveal Biomarker Evidence Of Therapeutic Effect On Fibrosis And Inflammation In NASH With Advanced Fibrosis

  • GR-MD-02 was safe and well tolerated in patients
  • Galectin Therapeutics to host webcast, April 1, 8:30 a.m. EDT to discuss first cohort findings
  • Second cohort of Phase 1 trial to begin enrollment in April

NORCROSS, Ga., March 31, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that results from the first cohort of its Phase 1 trial show that GR-MD-02 had an effect on biomarkers that suggest a therapeutic effect on fibrosis, inflammation, and cellular injury. The first-in-man study, which enrolled eight patients in the first cohort, is evaluating the safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of its galectin-inhibiting drug GR-MD-02 when administered to patients with fatty liver disease (NASH) with advanced fibrosis.

First cohort results indicate that GR-MD‑02 was safe and well tolerated following four doses of 2 mg/kg (80 mg/m 2) and there were no serious adverse events. The pharmacokinetics were consistent between individuals and after single and multiple doses with no drug accumulation after multiple doses. In assessing secondary endpoints, it was found that multiple biomarkers of fibrosis and inflammation showed improvement after four doses of GR-MD-02. Additionally, patients with greater evidence of liver cell injury, as indicated by elevated transaminase enzyme levels, had a marked decrease in CK-18, a clinically validated biomarker of cell death. Galectin-3 blood levels, which do not correlate with tissue levels in NASH, were not changed with treatment.

Details of the findings will be discussed by the Company on a webcast and conference call on Tuesday, April 1 at 8:30 a.m. Eastern Daylight Time. The webcast can be accessed at the following link: http://w.on24.com/r.htm?e=773833&s=1&k=A95A6017BF0762550B5252D80F9A24FF. Audio only can be accessed using the following call-in number: 866-219-3563, conference ID 19710441. The presentation is now posted on the Company's website ( www.galectintherapeutics.com ) for review before the webcast.

"We are extremely pleased with the positive results of the first cohort of our Phase 1 trial, which suggest a role for GR-MD-02 in the treatment of patients with fatty liver disease with advanced fibrosis," said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer of Galectin Therapeutics. "Fatty liver disease, characterized by the presence of fat in the liver along with inflammation, over time can develop into fibrosis, or scarring of the liver, which is estimated to affect millions of Americans. Intervention with the intent of reversing the fibrosis is a potentially important therapeutic approach in fatty liver disease, a condition with significant unmet medical need."

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