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July 25, 2017

Press Releases

Patent for Enhancing Immunotherapy in Cancer Treatment Granted to Galectin Therapeutics

NORCROSS, Ga., July 25, 2017 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc.(NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that the Company has received notice of allowance for a U.S. Patent for "Method of Enhancing Specific Immunotherapies in Cancer Treatment." Cancer immunotherapy research conducted by Dr. William Redmond at the Earle A. Chiles Research Institute at the Providence Cancer Center in Portland, Oregon was instrumental in the allowance of this patent. Members of Galectin and Providence are joint inventors on the patent, and Galectin holds the exclusive license. The patent's principal claims cover method of use of GR-MD-02 as a means to enhance anti-tumor activity and increase survival effects of combining GR-MD-02 with multiple clinically relevant types of immune modulators, such as KEYTRUDA®; and for multiple types of cancer.

This patent provides intellectual property protection for the ongoing human trial that evaluates the effect of the combination of GR-MD-02 with approved cancer immunotherapy drugs. Results of the first cohort of the Phase 1b study of a galectin inhibitor (GR-MD-02) and pembrolizumab (KEYTRUDA®) in patients with metastatic melanoma were reported earlier this year, and now Galectin reports that the second cohort of three patients treated with 4 mg/kg of GR-MD-02 has been completed, and the third cohort of 10 patients treated with 8 mg/kg will begin enrollment after the patients in the second cohort have completed 85 days of protocol, as per FDA agreement (more information at clinicaltrials.gov).

Additionally, the patent covers the ability of GR-MD-02 to enhance the effectiveness of immune modulators in a variety of cancers, including gastrointestinal cancer, pancreatic cancer, bile duct cancer, sarcoma, myosarcoma, breast cancer, lung cancer, head and neck cancer, mouth cancer, skin cancer, melanoma, kidney cancer, urinary tract cancer, prostate cancer, testicular cancer, ovarian cancer, endometrial cancer, neurological cancer, endocrine gland cancer, bone cancer, hematological cancers, multiple myeloma, and myelofibrosis.  The patent coverage extends through 2033.

"This patent protects our ability to use GR-MD-02 to enhance the effectiveness of multiple classes of immune modulators, in the treatment of a wide range of cancers," said Peter G. Traber, M.D., chief executive officer and chief medical officer of Galectin Therapeutics.  "This patent arose from research conducted by Dr. Redmond at the Earle A. Chiles Research Institute and Providence Cancer Center, which is also conducting the clinical trials under Principal Investigator Dr. Brendan Curti.  We look forward to continuing our relationship in more extensive trials."

William L. Redmond, Ph.D., Associate Member, Laboratory of Cancer Immunotherapy and Director, Immune Monitoring Laboratory, Earle A. Chiles Research Institute at the Providence Cancer Center, one of the inventors on the patent, said, "Based on the effects of GR-MD-02 in animal models of cancer and the early results of the Phase 1b trial in patients with advanced melanoma, oral/head and neck cancer (OHN) or non-small cell lung cancer (NSCLC), we believe continuing the KEYTRUDA and GR-MD-02 arm of the combination immunotherapy study is warranted."

With this patent, the Company now holds 17 granted U.S. patents, 24 foreign granted patents (Japan, E.U., New Zealand, and Australia). Additionally, the Company has 49 international patent applications, and 4 U.S. patent applications in process. Many of the Company's patents and patent applications cover composition of matter for complex carbohydrate drugs and methods of use for reducing toxicity and enhancing chemotherapeutic drugs by co-administering a polysaccharide with a chemotherapeutic agent or for use in treatment of fibrosis.  Granted patents include composition of matter, process of manufacture, and various methods of use.  The breadth of coverage for the patent portfolio includes; various types of organ fibrosis (liver, lung, kidney, and heart), non-alcoholic steatohepatitis, kidney disease, autoimmune disorders and cancer, including combination cancer immunotherapy.

GR-MD-02, a Non-Biological Complex Drug (NBCD), is a proprietary polysaccharide pharmaceutical preparation that inhibits galectin proteins.  In addition to the Combination Immunotherapy cancer trials, GR-MD-02 is currently being studied in a Phase 2b clinical trial in subjects with NASH cirrhosis. Additionally, GR-MD-02 has been studied and shown encouraging preliminary results in two, open-label Phase 2a trials in patients with severe skin diseases, including moderate-to-severe plaque psoriasis and atopic dermatitis.

About Galectin Therapeutics
Galectin Therapeutics is developing promising therapies for the treatment of fibrotic liver disease, skin diseases, 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.

About Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute (EACRI), Providence Cancer Center, Providence Portland Medical Center
Providence Cancer Center, a part of Providence Health & Services, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. The Robert W. Franz Cancer Research Center in the Earle A. Chiles Research Institute is a world-class research facility located within Providence Cancer Center. The Institute's main area of investigation is cancer immunotherapy, a specialized field of study focused on triggering the immune system to fight cancer. Visit www.chilesresearch.org.

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. 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, 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.


Galectin Therapeutics, Inc.Jack Callicutt, Chief Financial Officer



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Source: Galectin Therapeutics

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