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Galectin Therapeutics And Providence Portland Medical Center Receive OK From FDA To Proceed With Phase 1B Clinical Trial In Metastatic Melanoma

NORCROSS, Ga., Feb. 3, 2014 (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 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® (ipilimumab) in patients with metastatic melanoma may proceed. Providence Portland Medical Center, a leader in immunotherapy research and translational clinical trials in melanoma and other cancers, 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.

"The FDA's IND agreement to proceed with the clinical trial is a critical step in seeking a new treatment option for metastatic melanoma, a devastating diagnosis for tens of thousands of Americans each year," said Dr. Peter G. Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics. "We expect the trial to begin enrollment in March. Future communications will outline expected milestone timings for the study."

GR-MD-02 is Galectin Therapeutics' proprietary molecule that binds to and inhibits galectin proteins, predominantly galectin-3. A preclinical study led by tumor immunology expert William L. Redmond, Ph.D., of EACRI found that GR-MD-02 increased tumor shrinkage and enhanced survival in immune competent mice with prostate and breast cancers when combined with one of the immune checkpoint inhibitors, anti-CTLA-4 or anti-PD-1. These findings suggest a role for GR-MD-02 in cancer immunotherapy.

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