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Galectin Therapeutics Receives US Patent

05-Aug-2014 | Source : AG-IP News | Visits : 6017
NORCROSS, Ga. - Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced in a press release that it has received a notice of allowance from the US Patent and Trademark Office for patent application number 13/573,442 titled "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases." The patent covers composition and chemical structural claims for compounds that includes the Company's lead galectin inhibitor compound GR-MD-02 and will expire in December 2031.

Claims include multiple routes of administration, including intravenous, subcutaneous and oral. The application also covers therapeutic formulations for use in the treatment of NASH (fatty liver disease), cancer and fibrotic, inflammatory and autoimmune disorders in which galectin proteins are involved, at least in part, in the pathogenesis. Additional specific claims encompass liver fibrosis, kidney fibrosis, lung fibrosis or heart fibrosis. NASH is estimated to effect approximately three to five percent of the US population, which is approximately 12 million Americans. Of this, 15 percent are estimated to eventually develop cirrhosis; and the incidence of hepatic cellular carcinoma has been estimated to be as high as 15 percent. Currently, there are no approved therapies for the treatment of NASH or liver fibrosis.

"This patent provides composition of matter coverage for GR-MD-02, our lead proprietary galectin inhibitor, which has shown in studies to have a powerful therapeutic effect on fibrosis and inflammation," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "In pre-clinical studies, we found that treatment with GR-MD-02 reversed experimentally-induced liver fibrosis and cirrhosis. In separate experiments, GR-MD-02 has been shown to reverse experimentally-induced fibrosis in the lungs, heart and kidneys. This patent secures the path forward for the Company's exploration of the effects of galectin inhibition in NASH with advanced fibrosis and in selected other fibrotic diseases of the lung, heart, and kidney."

Galectin Therapeutics is currently conducting a Phase 1 clinical trial to evaluate the safety, tolerability and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 over four weekly doses of GR-MD-02 treatment in patients with fatty liver disease with advanced fibrosis. Trial details can be found at http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1. Results from the first and second cohort met the primary endpoint of demonstrating that four doses of 2 mg/kg and 4 mg/kg were safe and well tolerated and showed predictable and proportionate pharmacokinetics. GR-MD-02 is also being studied in a Phase 1B clinical trial in combination with ipilimumab in patients with metastatic melanoma being conducted at the Providence Portland Medical Center. Trial details can be found at http://www.clinicaltrials.gov/ct2/show/NCT02117362?term=NCT02117362&rank=1
Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com

 
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