NORCROSS, Ga., June 27, 2018 (GLOBE NEWSWIRE) — Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the Company has received notice of issuance of U.S. Patent Number 9,968,631 titled “Method and Treatment of Pulmonary Fibrosis.” The patent’s principal claims cover method of use of GR-MD-02 as a means to treat pulmonary fibrosis. The patent is expected to provide broad protection for the use of GR-MD-02 for compositions, methods of using and methods of manufacturing compositions capable of treating pulmonary fibrosis. The patent coverage extends to 2032.
The patent includes a method in obtaining a composition for parenteral or enteral administration comprising a galacto-rhamnogalacturonate in a pharmaceutical acceptable carrier and administering to a subject in need of an effective dose of the composition that results in at least five percent improvement of pulmonary function tests where the subject has at least a primary or secondary lung fibrotic disease. The Company’s GR-MD-02 compound is covered by this patent.
“This patent protects our commercial ability to use GR-MD-02 to potentially treat pulmonary fibrosis and is yet another example of the widespread applicability of our galectin-3 inhibitor in treating fibrotic disease,” said Dr. Harold H. Shlevin, chief executive officer of Galectin Therapeutics. “Pharmaceutical companies may have an interest in this disease as there is a sizeable section of the population in need of treatment and well defined regulatory pathways for approval of agents to treat pulmonary fibrosis. This patent further strengthens the protection of the intellectual property behind our proprietary compound, GR-MD-02, which has been shown in animal models to resolve fibrosis in a variety of tissues and organs. The company is currently focused on planning and conducting additional supportive work to prepare for a Phase 3 trial for GR-MD-02 in NASH cirrhosis based on the positive effects of GR-MD-02 on HVPG and the possible prevention or postponement of development of esophageal varices in its Phase 2 NASH-CX trial, which we believe is the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in these patients.”
About Galectin Therapeutics
Galectin Therapeutics is developing promising 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 and those regarding the hope that our lead compounds will be successful in connection with cancer immunotherapy and in other fibrotic disease including amongst others in pulmonary fibrosis. 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; 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, 2017, 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.
Galectin Therapeutics, Inc.
Jack Callicutt, Chief Financial Officer