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. Galectin proteins are known to be markedly increased in a number of important diseases including scaring of organs and cancers of many kinds. The company has two compounds in development, one intended to be used in the treatment of liver fibrosis and fatty liver disease and the other intended to be used in cancer therapy. These two compounds are produced from completely different, natural, readily available, starting materials, which, following chemical processing, both exhibit the property of binding to and inhibiting galectin proteins. GR-MD-02: GR-MD-02 is the company’s main product candidate for treatment of fibrotic disease. In January 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. In March 2013, the FDA indicated the company could proceed with a U.S. Phase 1 clinical trial for GR-MD-02 with a development program aimed at obtaining support for a proposed indication of GR-MD-02 for treatment of NASH with advanced fibrosis. GM-CT-01: GM-CT-01, its product candidate targeted for selective cancer therapy, is in a clinical trial in Europe. In 2012, the company initiated a Phase 1/2 clinical trial of GM-CT-01 in combination with a tumor vaccine in patients with advanced melanoma, a deadly skin cancer. The trial is being conducted at three centers in Belgium and one in Luxembourg. The operational conduct of the trial is under the control of the Cancer Centre at the Cliniques Universitaires Saint-Luc and the Ludwig Institute for Cancer Research. 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 As of December 31, 2012, the company held eight U.S. patents, three international patents, and had patent applications pending from the U.S. Patent and Trademark Office. Its patents and patent applications cover composition of matter for complex carbohydrate drugs and methods of use for reducing toxicity and enhancing chemotherapeutic drugs by co-administering a polysaccharide with a chemotherapeutic agent or for use in treatment of fibrosis. The scheduled expiration dates of its United States patents span from 2020 to 2032. The company has corresponding patent applications pending in Europe, Canada, Israel, Brazil, Japan, China and Australia. Additionally, the company has patent applications in other areas to utilize its carbohydrate-based compounds to treat disease other than cancer. Research and Development The company’s primary focus is on the design and testing of agents which target galectins in various in vitro and in vivo systems and which moreover demonstrate efficacy in treatment of experimentally induced fibrosis or enhance immune system responsiveness in various tissues and in live animal models. In February 2013, the company established a collaborative drug discovery program with Dr. Geert-Jan Boons’ (Dr. Boons) laboratory located in the Complex Carbohydrate Research Center at the University of Georgia. This program is focused on the discovery of new carbohydrate molecules that can be used in the therapy of diseases where galectin proteins play a major role, including cancer, and inflammatory and fibrotic disorders. The aim of this program is to develop a pipeline of drugs that can target galectins. The company’s research and development expenditures totaled $27.6 million, as of December 31, 2012. Significant Events In January 2014, Galectin Therapeutics Inc. and SBH Sciences, Inc. jointly announced the establishment and formation of Galectin Sciences, LLC, a collaborative venture to research and develop small organic molecule inhibitors of galectin-3 for oral administration. 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
(GALT:Consolidated Issue listed on NASDAQ Capital Market)
4960 Peachtree Industrial Boulevard
Norcross, GA 30071
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