Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported its financial results for first quarter, ended March 31, 2012. These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the SEC.
“Galectin made important progress in its clinical programs as well as its operations in the first quarter. Notably, the preclinical development of Galectin’s lead candidate for the treatment of fibrosis, GR-MD-02, continues on track and we expect to file an investigational new drug application with the US FDA by year end,” said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics. “Accordingly, we plan to initiate a Phase 1 clinical trial of GR-MD-02 in patients with NASH and fibrosis in early 2013 to assess safety and preliminary evidence of efficacy in humans with Phase 2 studies potentially beginning by the end of next year with expected top-line results by the end of 2014. The novel mechanism of GR-MD-02, in combination with compelling preclinical data, gives us great hope that this compound may ultimately meet the needs of these patients with this deadly disease that has no currently approved therapeutic options.”
Traber continued, “As previously disclosed, the Company has refocused its pipeline of galectin inhibitors in cancer to reflect the highest likelihood of creating value in the near-term and is now developing GM-CT-01 in melanoma. This development strategy is based on compelling data demonstrating that GM-CT-01 can protect a patient’s immune system from the “Galectin Effect”; whereby tumors secrete galectin proteins that block the body’s efforts to fight tumors. We are collaborating with the Ludwig Institute, where the Galectin Effect was discovered, for a Phase 2 clinical evaluation of GM-CT-01 which is currently underway. We feel that melanoma is an ideal indication because it is an immunologically responsive tumor and there are newly approved therapies that we suspect will be synergistic with GM- CT-01.”