), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the first patient has been dosed in cohort 1 of the Company's Phase 1B clinical trial evaluating GR-MD-02 in combination with ipilimumab (Yervoy®) in patients with metastatic melanoma. Providence Portland Medical Center's Earle A. Chiles Research Institute (EACRI), a leader in immunotherapy research and translational clinical trials in melanoma and other cancers, is conducting the study under principal investigator Brendan D. Curti, M.D. The study employs a 3+3 Phase 1 design with dose escalation of GR-MD-02, a galectin inhibitor, in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. Cohort 1, which seeks to enroll at least 3 patients (and up to 6 should there be drug associated adverse events), will utilize 1 mg/kg of GR-MD-02 administered one hour before 3 mg/kg of ipilimumab on days 1, 22, 43 and 65. 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. Tumor volume will be assessed by immune response RECIST criteria. Additional trial details can be found at http://www.clinicaltrials.gov/ct2/show/NCT02117362?term=NCT02117362&rank=1. "Preclinical data have shown that GR-MD-02 holds immense potential for increasing the effectiveness of other therapies and may be an important approach in enhancing cancer immunotherapy," said Dr. Peter G. Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics. "This Phase 1B clinical trial is a significant step in investigating a new treatment option for advanced melanoma, the most deadly form of skin cancer." 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. "Dr. Redmond's preclinical work suggests a role for GR-MD-02 in cancer immunotherapy," said Dr. Curti, the trial's principal investigator, a medical oncologist and director of the Providence Biotherapy Program at EACRI. "This Phase 1B trial will build on this momentum and significantly contribute to our scientific understanding of the effects of GR-MD-02 in combination with ipilimumab in metastatic melanoma." Galectin Therapeutics is providing its proprietary compound GR-MD-02 to EACRI researchers, as well as supplying 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. YERVOY ® is a registered trademark of Bristol-Myers Squibb Company.