NORCROSS, Ga., Jan. 21, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that data from a preclinical study show its leading galectin-inhibiting drug GR-MD-02 demonstrates an effect on a blood biomarker in an animal model of nonalcoholic steatohepatitis (NASH, or fatty liver disease) with fibrosis. Hyaluronic acid, a well investigated marker of liver fibrosis, was significantly reduced by approximately 33 percent when untreated animals were compared with those treated with GR-MD-02.
In the study, NASH-induced mice were treated with once weekly doses of GR-MD-02 at four different doses for a total of six weeks of treatment. Results revealed that treatment with GR-MD-02 at doses of 10, 30, and 60 mg/kg body weight significantly reduced the plasma levels of hyaluronic acid in the NASH mice. Other biomarkers examined did not change (MIG (monokine induced by interferon gamma) and TIMP-1 (tissue inhibitor of metalloproteinase)) or were not detectable (IP-10 (interferon inducible protein), KC (keratinocyte-derived chemokine), MIP-1α (macrophage inflammatory protein), and MCP-1 (monocyte chemo-attractant protein). Importantly, plasma levels of galectin-3 were measurable and did not change with therapy, indicating that changes in tissue galectin-3 and improvement in NASH histology do not correlate with blood levels of galectin-3 in this model.
"These results in this preclinical model of NASH show that improvement in NASH and fibrosis with GR-MD-02 treatment appear to correlate with plasma levels of hyaluronic acid, a biomarker that has been shown in multiple human studies to correlate with liver fibrosis," said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics. "We are examining the levels of hyaluronic acid as well as multiple other markers of inflammation, cell death and fibrosis in our current Phase 1 clinical trial of GR-MD-02 in NASH patients with advanced fibrosis."