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 the third quarter and first nine months ended September 30, 2012. These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the SEC.
“We have continued to make progress with our primary candidate, GM-CT-01 in melanoma, part of our pipeline of galectin inhibitors in cancer,” said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics. “There is strong in vitro data that demonstrates that GM-CT-01 can protect immune cells from the ‘Galectin Effect’; whereby tumors secrete galectin proteins that block the body’s efforts to fight tumors. The trial, being conducted in collaboration with the Cancer Centre at the Cliniques Universitaires Saint-Luc and the Ludwig Institute for Cancer Research (LICR) in Brussels, is evaluating GM-CT-01 in combination with a Ludwig Institute peptide vaccine. In May, the first patient was dosed in a Phase 1/2 trial evaluating the safety and efficacy of GM-CT-01 in combination with a peptide tumor vaccine in metastatic melanoma. This trial is being conducted in two stages, and the results of the first stage will determine the timing and conduct of the second stage. We expect to have top-line clinical results for the first group of patients from the first stage of this trial in the second quarter of 2013.”
“The preclinical development of Galectin’s lead candidate for the treatment of liver fibrosis, GR-MD-02, continues on track and we expect to file an investigational new drug application (IND) with the US FDA by January 2013. Following the filing of the IND, we plan to initiate a Phase 1 clinical trial of GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH) and fibrosis in early 2013 followed by a Phase 2 study potentially beginning by early 2014 with expected top-line clinical results by the end of 2014 or early 2015. 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.”
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