Galectin Therapeutics Inc., a development-stage company, engages in drug research and development to create new therapies for fibrotic disease and cancer. The company’s drug candidates are based on its method of targeting galectin proteins, which are key mediators of biologic and pathologic functions. The company uses naturally occurring, readily-available plant materials as starting material in manufacturing processes to create proprietary complex carbohydrates with specific molecular weights and other pharmaceutical properties. These complex carbohydrate molecules are appropriately formulated into acceptable pharmaceutical formulations. The company focuses on diseases with serious, life-threatening consequences to patients and those where treatment options are limited. Drug Development Programs Galectins are a class of proteins that are made by many cells in the body. As a group, these proteins are able to bind to sugar molecules that are part of other proteins in and on the cells of its body. Galectin proteins act as a kind of glue, bringing together molecules that have sugars on them. The company has two compounds in development, GR-MD-02 and GM-CT-01, both of which have shown promise in preclinical studies in treatment of fibrosis and in cancer therapy. The company focuses on development of GR-MD-02 intended to be used in the treatment of liver fibrosis and fatty liver disease and in cancer therapy in combination with immune-system modifying agent(s). Fibrosis: GR-MD-02 is the company’s primary product candidate for treatment of fibrotic disease. The company’s preclinical data show that GR-MD-02 has a therapeutic effect on liver fibrosis as shown in various relevant animal models. In 2013, an Investigational New Drug (IND) was submitted to the U.S. Food and Drug Administration (FDA) with the goal of initiating a Phase I study in patients with non-alcoholic steatohepatitis (NASH) and advanced liver fibrosis to evaluate the human safety of GR-MD-02 and pharmacodynamics biomarkers of disease. The company’s drug candidate provides a new approach for the therapy of fibrotic diseases, and liver fibrosis in particular. Fibrosis is the formation of excess connective tissue (collagen and other proteins plus cellular elements, such as myofibroblasts) in response to damage, inflammation or repair. Cancer Immunotherapy: GM-CT-01, the company’s initial product candidate targeted for selective cancer therapy together with a potential melanoma vaccine, initially was being studied in a clinical trial in Europe. GM-CT-01 is a linear polysaccharide polymer comprising mannose and galactose. The primary focus of the company is to use galectin inhibitors to block galectin-3 and treat organ scarring or fibrosis in the liver. The company has evaluated the ability of GR-MD-02 to block galectin-3 in animal models of liver fibrosis, the conclusions of which yielded positive results. The company evaluated GR-MD-02 in pre-clinical toxicology and pharmacology studies during 2013 and filed an IND with the FDA in January 2013 for initiating human studies in patients with NASH. In 2013, the company entered into an agreement with CTI Clinical Trial Services to assist with the design, development and conduct of one or more clinical research studies, specifically for services with respect to its Phase 1 clinical trials to evaluate safety of GR-MD-02 in patients with NASH. GR-MD-02 is a proprietary galactoarabino-rhamnogalacturonan polysaccharide polymer that consists of galacturonic acid, galactose, arabinose, rhamnose, and smaller amounts of other sugars. With respect to GR-MD-02, the company has patent applications pending with respect to composition of matter, cancer immunotherapy, diabetic kidney disease, lung fibrotic disease, and inflammatory disease associated with increase in inducible nitric oxide synthase. In 2012, the company initiated a Phase 1/2 clinical trial of GM-CT-01 in Belgium in combination with a tumor vaccine in patients with advanced melanoma, a deadly skin cancer. GM-CT-01 was found to be generally safe when studied in a Phase 1 clinical trial in end-stage cancer patients with multiple tumor types alone and in combination with 5-Fluorouracil (5-FU), which is an FDA-approved chemotherapy used for treatment of various types of cancer. Strategy The company’s strategy is to establish and implement clinical development programs that add value to its business in the shortest period of time possible and to seek strategic partners when a program becomes advanced and requires additional resources. Patents and Proprietary Rights As of January 31, 2014, the company held nine granted U.S. patents, foreign granted patents (Japan, the E.U., and New Zealand), seven international patent applications, and had eight U.S. patent applications. The scheduled expiration dates of its United States patents span from 2020 to 2033. Significant Events In January, 2014, the company created, with SBH Sciences, Inc. (Natick, Ma), Galectin Sciences, LLC, a collaborative joint venture to research and develop small organic molecule inhibitors of galectin-3 for oral administration. Research and Development For the year ended December 31, 2013, the company’s research and development expenditures totaled $5.7 million. Government Regulation Failure to comply with the applicable U.S. requirements may subject the company to administrative or judicial sanctions, such as FDA refusal to approve pending New Drug Applications, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, and/or criminal prosecution. History The company was founded in 2000. It was incorporated in the state of Nevada in 2001. The company was formerly known as Pro-Pharmaceuticals, Inc. and changed its name to Galectin Therapeutics, Inc. in 2011.
galectin therapeutics inc
4960 Peachtree Industrial Boulevard
Norcross, GA 30071
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