Galectin Therapeutics, Inc., a clinical stage biopharmaceutical company, engages in the research and development of 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 products 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. Product Candidates Fibrosis GR-MD-02 is the company’s main product candidate for treatment of fibrotic disease. The company’s preclinical data show that GR-MD-02 has a significant therapeutic effect on liver fibrosis as shown in several 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 1 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 Phase 1 trial was completed and demonstrated that GR-MD-02 up to 8 mg/Kg, i.v. was safe and well tolerated and the human pharmacokinetic data defined a drug dose for use in the planned Phase 2 trials. The company’s drug candidate provides a new approach for the therapy of fibrotic diseases, and liver fibrosis in particular. Cancer Immunotherapy The company’s drug candidates provide a new therapeutic approach to improve the activity of the immune system against cancer cells. Preclinical studies have indicated that GR-MD-02 improves the immune response to cancer cells, increased tumor shrinkage and enhanced survival in immune competent mice with prostate, breast, melanoma and sarcoma cancers when combined with one of the immune checkpoint inhibitors, anti-CTLA-4 or anti-PD-1. These preclinical data led to the filing of an Investigator-sponsored IND and the initiation of a study of GR-MD-02 in combination with Yervoy (ipilimumab) in a Phase 1B study of patients with metastatic melanoma. Intellectual Property As of January 31, 2016, the company held 14 granted U.S. patents, 15 foreign granted patents (Japan, E.U., New Zealand, and Australia), 56 international patent applications, and 5 U.S. patent applications. The scheduled expiration dates of its United States patents span from 2020 to 2033. The company has corresponding patent applications pending in Europe, Israel, Australia and Brazil. Additionally, the company has patent applications in other areas to utilize its carbohydrate-based compounds to treat disease other than 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 significant additional resources. Research and Development As of December 31, 2015, the company’s expenditures for research and development included $13.1 million. Regulations The research, development, testing, manufacture, labeling, promotion, advertising, distribution, and marketing, among other things, of the company’s products are regulated by governmental authorities in the United States and other countries. The the U.S. Food and Drug Administration (FDA) regulates drugs under the federal Food, Drug, and Cosmetic Act and its implementing regulations. 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
(GALT:Consolidated Issue listed on NASDAQ Capital Market)
4960 Peachtree Industrial Boulevard
Norcross, GA 30071
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