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NORCROSS, Ga., March 21, 2014 (GLOBE NEWSWIRE) --
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 year ended December 31, 2013. These results are included in the Company's Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.
"Many important milestones and objectives were achieved in 2013 and continuing into the first quarter of 2014. During this period, we had significant activity involving our lead compound, GR-MD-02. We received notification from the U.S. Food and Drug Administration (FDA) that we may proceed with our Phase 1 clinical trial for GR-MD-02 in patients with fatty liver disease (NASH) with advanced fibrosis. Subsequently, we received FDA Fast Track designation for GR-MD-02 for fatty liver disease with advanced fibrosis, and we completed enrollment of the first cohort of patients in our Phase 1 clinical trial. Additionally, we enhanced our patent portfolio, and we have raised funds sufficient to finance our currently planned operations through 2015. Looking ahead, we expect to announce the results of the first cohort of patients in our Phase 1 clinical trial in early April 2014," said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics. "This Phase 1 first-in-man study is evaluating the safety, tolerability, pharmacokinetics and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis."
The Company also is working with Providence Portland Medical Center in planning for an investigator sponsored Phase 1 clinical trial to evaluate the combination of Bristol-Myers Squibb's Yervoy® (ipilimumab) and the Company's GR-MD-02 in patients with metastatic melanoma. This trial is based on pre-clinical data obtained in collaboration with Dr. Will Redmond at the center which demonstrated that the combination of immune checkpoint inhibitors like ipilimumab with GR-MD-02 enhances the antitumor effect in syngeneic mouse cancer models. This trial recently was approved by the FDA and expected to commence in the second quarter of 2014.