Press Release

NORCROSS, Ga., Jan. 25, 2018 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat non-alcoholic steatohepatitis (NASH) cirrhosis and cancer, announced today that the company has received two new patents in China and two new patents in Japan for the Company's lead compound, GR-MD-02.

"As the second and third largest pharmaceutical markets in the world, having strong patent protection for GR-MD-02 in China and Japan is strategically important to our company, particularly now that we have positive clinical data in both NASH cirrhosis and cancer immunotherapy,” said Peter G. Traber, M.D., chief executive officer and chief medical officer of Galectin Therapeutics and inventor on the patents. “As we consider partnerships to bring GR-MD-02 to the Asia markets for NASH cirrhosis cancer immunotherapies, and potentially other disorders, these patents will allow us and our future partners to take full advantage of our opportunities.”

The two patents from China provide broad intellectual property coverage. The first patent entitled "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases," covers GR-MD-02 composition of matter and methods of use broadly for the treatment of fibrosis, inflammatory and autoimmune disorders, or cancer. More specifically related to the clinical development programs, the patent covers NASH and liver fibrosis and immunotherapy of cancer.  The second patent entitled "Galacto-Rhamnogalacturonate Compositions for the Treatment of Diseases Associated with Elevated Inducible Nitric Oxide Synthase," extends the use of GR-MD-02 to a variety of other diseases including neurodegenerative disease, psoriasis, cutaneous and systemic lupus erythematosus, systemic sclerosis (scleroderma) and dermatitis.

The two new Japanese patents, in combination with the Company’s two existing Japanese patents, provide broad intellectual property coverage including GR-MD-02 composition of matter and all potential therapeutic indications under development in this important pharmaceutical market. The first of the two new patents, entitled “Galacto-Rhamnogalacturonate Compositions for the Treatment of Non-Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease,” provides specific coverage for the Company’s lead indication of NASH cirrhosis for GR-MD-02. The new allowed continuation patent, entitled "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases," extends coverage of the Company's lead compound, GR-MD-02 to pharmaceutical compositions for use in combination with multiple cancer immunotherapies, including those that target PD-1, PD-L1, CTLA-4, or OX-40. The patent coverage period for each of these Japanese and Chinese patents extends through 2032.

Positive Results in NASH Cirrhosis
GR-MD-02, a proprietary polysaccharide pharmaceutical preparation that inhibits galectin proteins, recently showed in a Phase 2b clinical trial (NASH-CX) that there were statistically significant and clinically relevant positive effects in patients with NASH cirrhosis without esophageal varices. The Company believes that this is the first randomized clinical trial of any drug to demonstrate clinically meaningful positive effects in this important group of patients.

Encouraging Results in Cancer Immunotherapy
GR-MD-02 also showed encouraging Phase 1b results in combination with pembrolizumab (KEYTRUDA®) to treat advanced melanoma. In the first two cohorts of this study, five out of eight patients (62.5 percent) with advanced melanoma had objective responses, with two complete and three partial responses, which compares favorably with the known response rates with pembrolizumab alone (~33 percent). The study continues with additional results expected in Summer, 2018.

About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver and skin diseases and cancer. Galectin's lead drug (GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein that is directly involved in multiple inflammatory, fibrotic, and malignant diseases. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are for treatment of severe atopic dermatitis, moderate-to-severe plaque psoriasis, and in combination immunotherapy for advanced melanoma and other malignancies. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. 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, those regarding the hope that our lead compounds will be successful in connection with cancer immunotherapy, and that the therapeutics may be successfully approved and marketed in China and/or Japan. 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 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; the Company may find that its patents, particularly in foreign jurisdictions, does not offer the protection anticipated, and  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, 2016, 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.

Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc.

Contact:

Galectin Therapeutics, Inc.
Jack Callicutt, Chief Financial Officer
678-620-3186
ir@galectintherapeutics.com

Source: Galectin Therapeutics Inc.