Galectin Therapeutics Granted Patents in China and Japan that Support NASH and Cancer Immunotherapy Clinical Development Programs
"As the second and third largest pharmaceutical markets in the world, having strong patent protection for GR-MD-02 in
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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
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Source: Galectin Therapeutics Inc.