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Galectin Therapeutics To Host Webcast To Discuss Findings From Cohort 2 Of Phase 1 Clinical Trial Of GR-MD-02 In Fatty Liver Disease With Advanced Fibrosis


7/25/2014 8:00:03 AM

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NORCROSS, Ga., July 25, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced the Company will hold a webcast on Tuesday, July 29, 2014 at 8:30 a.m. Eastern Daylight Time to discuss the findings from cohort 2 of a Phase 1 clinical trial evaluating its galectin inhibitor GR-MD-02 in fatty liver disease (NASH) with advanced fibrosis.

Registration and access to the live webcast can be found at the following link: http://w.on24.com/r.htm?e=824339&s=1&k=03EDE683D3FB138088B03D9226655B4B Audio only can be accessed using the following call-in number: (866) 219-3563, conference ID: 74783858. Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer of Galectin Therapeutics Inc., will present the findings of cohort 2. A corresponding presentation will be posted on the Company website (www.galectintherapeutics.com) prior to the presentation.

The first-in-man study, which enrolled eight patients in the second cohort, is evaluating the safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of galectin-inhibiting drug GR-MD-02 when administered to patients with fatty liver disease (NASH) with advanced fibrosis. Patients in cohort 2 were dosed at 4 mg/kg, which is double the dose given in cohort 1. The trial used FibroScan® to gain experience in the potential use of this device for future Phase 2 studies. FibroScan® is approved by the U.S. Food and Drug Administration for noninvasive measurement of shear wave speed at 50 Hz in the liver and may be used as an aid to clinical management of patients with liver disease.

The Phase 1 multi-center, blinded (to healthcare providers and patients) clinical trial is being conducted in patients with NASH with advanced fibrosis (Brunt Stage 3) who receive four doses of GR-MD-02 over a 42-day period. Each of the three planned cohorts consists of eight patients, six randomized to receive active drug and two randomized to receive placebo. Trial design details can be found at http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1.

About Fatty Liver Disease with Advanced Fibrosis

Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, 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 drink 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 three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.

About Galectin Therapeutics

Galectin Therapeutics (Nasdaq:GALT) 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, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements

This press release contains, in addition to historical information, 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 our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. These statements include those regarding the clinical trial, our drug development program, and estimates regarding individuals that may develop cirrhosis. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that we may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of our other drugs in development. Our 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. We may have difficulty enrolling new patients, which could impact timing and costs. Results from the first and second cohort of Phase 1 are not necessarily indicative of future results in the clinical trial. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Regardless of the results of any of our development programs, we may be unsuccessful in developing partnerships with other companies that would allow us to further develop and/or fund any studies or trials. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2013, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

CONTACT: Galectin Therapeutics Inc. Peter G. Traber, MD, 678-620-3186 President, CEO, & CMO ir@galectintherapeutics.com

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