Galectin Therapeutics Reports on Key 2013 Scientific, Development and Regulatory Milestones, Highlights Corporate and Financial Activity
NORCROSS, Ga., Jan. 8, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today released a report on the Company's key scientific, development and regulatory milestones and corporate activity that contributed to the Company's progress in 2013.
Key activity in 2013 included:
Submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company's proprietary galectin inhibitor GR-MD-02 in fatty liver disease, and subsequent notification from the FDA to proceed with a Phase 1 clinical trial for GR-MD-02 in fatty liver disease with advanced fibrosis.
Receipt of Fast Track designation from the FDA for GR-MD-02 in fatty liver disease.
First patient enrolled in the first-in-man Phase 1 clinical trial for GR-MD-02 in fatty liver disease, currently taking place at six trial sites across the U.S.
Preclinical data showed the Company's galectin inhibitors may have therapeutic effect in diabetic kidney disease, contribute to reversal of cirrhosis and reduction of fibrosis, and significantly improve non-alcoholic steatohepatitis (NASH) activity.
Two executives were added to the Company's management team and several key investments occurred, including the exercise of common stock purchase warrants and a private placement of 500,000 shares of unregistered common stock.
"I am pleased to report that 2013 was a year of noteworthy progress for Galectin Therapeutics," said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics. "We believe strongly that galectin inhibitors hold immense promise for the treatment of fibrosis and inflammation, and the Company will continue to work diligently toward the ultimate goal of bringing a first-in-class treatment to the millions of Americans suffering from fatty liver disease with advanced fibrosis."
A summary of Galectin Therapeutics' accomplishments in 2013 can be found on the Company's website at www.galectintherapeutics.com/GALT2013.
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