Press Release
Galectin Therapeutics Presented Research With GR-MD-02 at the American Association for the Study of Liver Diseases Industry Colloquium
NORCROSS, Ga., March 24, 2015 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces that Peter G. Traber, M.D., president, chief executive officer and chief medical officer, delivered an invited presentation of the Company's research with lead compound GR-MD-02 in non-alcoholic steatohepatitis (NASH) at the American Association for the Study of Liver Diseases (AASLD) Industry Colloquium. The Industry Colloquium: Novel Targets and Therapies in Liver was held at the Hilton Durham Research Triangle Park in North Carolina.
Dr. Traber participated in the session entitled "NASH: Clinical Endpoints and Drug Development" on March 21. He discussed the role of galectin-3 in organ fibrosis generally and liver fibrosis in particular, and GR-MD-02 as a galectin-3 inhibitor. He reviewed the published preclinical data which show that GR-MD-02 is effective in reversing inflammation and fibrosis in a mouse model of NASH and also in reversing cirrhosis and improving portal hypertension in a rat model of cirrhosis. He also reviewed the data that GR-MD-02 reduces galectin-3 expression in preclinical disease models and, following an intravenous dose, over 90% of GR-MD-02 is taken up by the liver and is found predominantly in macrophages, the major target of its action. Finally, he reviewed the Company's Phase 1 study results and its Phase 2 clinical program design. The abstract of Dr. Traber's presentation has been posted to the Company's website.
"I'm honored that I was invited to present at this prestigious colloquium," said Dr. Traber. "I am pleased that the medical community and industry are mobilizing to address the needs of a growing number of patients who develop NASH, and subsequently progress to liver fibrosis and cirrhosis."
About AASLD
AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists (including Hans Popper, Leon Schiff, Fred Hoffbauer, Cecil Watson, Jesse Bollman, and Sheila Sherlock, to name a few) to bring together those who had contributed to the field of hepatology. AASLD has grown to an international society responsible for all aspects of hepatology, and its annual meeting, The Liver Meeting®, has grown in attendance from 12 to more than 9,500 physicians, surgeons, researchers and allied health professionals from around the world. More information is at http://www.aasld.org/about-aasld#sthash.fI9KDk6f.dpuf.
About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scaring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates. NASH is estimated to affect up to 28 million people in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who consume little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as 1-2 million individuals in the U.S. will develop cirrhosis, a severe liver disease for which liver transplantation is the only treatment available. Approximately 6,300 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.
About Galectin Therapeutics
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, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on management's current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin's development program for GR-MD-02 will lead to the first therapy for the treatment of fatty liver disease with cirrhosis. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of its other drugs in development. The Company's current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of Galectin's drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies. There is no certainty that FDA and Company will agree on a SPA or that a SPA would ultimately be acceptable to FDA nor result in approval of GR-MD-02. Regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin's business, see the Company's Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
CONTACT: Galectin Therapeutics Inc. Peter G. Traber, M.D. President, CEO & CMO (678) 620-3186 ir@galectintherapeutics.com LHA Kim Golodetz (212) 838-3777 kgolodetz@lhai.com