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galectin therapeutics inc (GALT) Key Developments

Galectin Therapeutics to Announce Results from First Cohort of Phase 1 Clinical Trial in Fatty Liver Disease

Galectin Therapeutics announced that on March 31, 2014, the company will report results from the first cohort of its Phase 1 clinical trial examining GR-MD-02 in fatty liver disease (NASH) with advanced fibrosis. The first-in-man study, which enrolled eight patients in the first 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 with advanced fibrosis. The Phase 1 multi-center, partially-blinded clinical trial is being conducted in a total of 24 patients who receive four weekly doses of GR-MD-02. Each of the three cohorts consists of eight patients, six randomized to receive active drug and two randomized to receive placebo. Eight U.S. clinical sites with extensive experience in clinical trials in liver disease are now active to ensure rapid enrollment of the second cohort. GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin proteins play a major role in diseases that involve scaring of organs such as cancer, and inflammatory and fibrotic disorders. The drug binds to galectin proteins and disrupts their function. Preclinical data has shown that GR-MD-02 has robust treatment effects in reversing fibrosis and cirrhosis. 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.

Galectin Therapeutics, Inc. - Special Call

To review results from the first cohort of its Phase 1 clinical trial examining GR-MD-02 in fatty liver disease (NASH) with advanced fibrosis

Galectin Therapeutics, Inc. Reports Consolidated Financial Results for the Year Ended December 31, 2013

Galectin Therapeutics, Inc. reported consolidated financial results for the year ended December 31, 2013. For the year ended December 31, 2013, the company reported a net loss applicable to common stock of $21.9 million or $1.30 per share basic and diluted compared with a net loss applicable to common stock of $10.9 million or $0.72 per share basic and diluted for 2012. The increase in net loss applicable to common stock is largely due to an $8.8 million or $0.53 per share one-time, non-cash charge related to modification of certain warrants recorded in the second quarter of 2013 and an unrelated one-time, non-cash stock compensation charge of $1.0 million or $0.06 per share recorded in the third quarter of 2013. Total operating loss was $12.104 million against $9.899 million a year ago.

Galectin Therapeutics, Inc. and Providence Portland Medical Center Receive Approval from FDA to Proceed with Phase 1B Clinical Trial in Metastatic Melanoma

Galectin Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has agreed that a Phase 1B clinical trial of the galectin inhibitor GR-MD-02 in combination with Yervoy(R) (ipilimumab) in patients with metastatic melanoma may proceed. Providence Portland Medical Center filed the IND in late December 2013. Providence Portland Medical Center's Earle A. Chiles Research Institute (EACRI) will conduct the Phase 1B study under principal investigator Brendan D. Curti, M.D. The study will employ a 3+3 Phase 1 design with dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. Researchers will assess the effects of GR-MD-02 with ipilimumab on melanoma response by inducing proliferation, activation and memory function of CD8+ T cells. In addition to monitoring for toxicity and clinical response, blood samples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition. GR-MD-02 is Galectin Therapeutics' proprietary molecule that binds to and inhibits galectin proteins, predominantly galectin-3. These findings suggest a role for GR-MD-02 in cancer immunotherapy. Galectin Therapeutics will provide its proprietary compound GR-MD-02 to EACRI researchers, as well as supply researchers with supporting analysis of the pharmacokinetics of GR-MD-02 and the right to reference the Company's open IND on GR-MD-02.

Galectin Therapeutics Inc. and SBH Sciences, Inc. Announce the Formation of Galectin Sciences, LLC, a Collaborative Venture to Research and Develop Galectin Inhibitors for Oral Administration

Galectin Therapeutics Inc. and SBH Sciences, Inc. jointly announced the establishment and formation of Galectin Sciences, LLC, a collaborative venture to research and develop small organic molecule inhibitors of galectin-3 for oral administration. Using computer molecular modeling techniques coupled with in vitro screening of a variety of compound libraries, SBH Sciences recently identified several small organic molecules with promising galectin-3 inhibitory activity in vitro. Galectins, a class of proteins made by many cells in the body, are known to be markedly increased in a number of diseases including scaring of organs and cancers of many kinds. Galectin Sciences, a Georgia-based LLC jointly owned by Galectin Therapeutics and SBH Sciences, will allow the companies to collaborate in further development of these unique organic molecule inhibitors of galectin-3 as drug candidates as well as discovery of additional candidates. Galectin Sciences will build on the scientific body of knowledge amassed by SBH Sciences, coupled with Galectin Therapeutics' knowledge and expertise of galectins' pathological role and mechanism of action in inflammation, fibrosis and many cancers. The long-term goal of this effort is to identify and develop drug candidates that are highly specific galectin inhibitors which may be formulated for oral administration. The intermediate term goal is the development of small molecule inhibitors of galectin-3 which exhibit activity in vivo preclinical disease models of fibrosis and cancer in which galectins play a key role.


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