Galectin Therapeutics Reports First Patient Dosed in Cohort 1 of Phase 1B Clincial Trial of GR-MD-02 in Combo with Ipilimumab in Metastatic Melanoma

Galectin Therapeutics Inc.(Nasdaq: GALT), the leading developer of therapeutics that target galectinproteins to treat fibrosis and cancer, today announced that the first patienthas been dosed in cohort 1 of the Company's Phase 1B clinical trial evaluatingGR-MD-02 in combination with ipilimumab (Yervoy®) in patients with metastaticmelanoma. Providence Portland Medical Center's Earle A. Chiles ResearchInstitute (EACRI), a leader in immunotherapy research and translationalclinical trials in melanoma and other cancers, is conducting the study underprincipal investigator Brendan D. Curti, M.D.The study employs a 3+3 Phase 1 design with dose escalation of GR-MD-02, agalectin inhibitor, in conjunction with the standard therapeutic dose ofipilimumab in patients with advanced melanoma for whom ipilimumab would beconsidered standard of care. Cohort 1, which seeks to enroll at least 3patients (and up to 6 should there be drug associated adverse events), willutilize 1 mg/kg of GR-MD-02 administered one hour before 3 mg/kg of ipilimumabon days 1, 22, 43 and 65. Researchers will assess the effects of GR-MD-02 withipilimumab on melanoma response by inducing proliferation, activation andmemory function of CD8+ T cells. In addition to monitoring for toxicity andclinical response, blood samples will be obtained to assess immunologicmeasures relevant to galectin biology and ipilimumab T-cell check-pointinhibition. Tumor volume will be assessed by immune response RECIST criteria.Additional trial details can be found athttp://www.clinicaltrials.gov/ct2/show/NCT02117362?term=NCT02117362&rank=1."Preclinical data have shown that GR-MD-02 holds immense potential forincreasing the effectiveness of other therapies and may be an importantapproach in enhancing cancer immunotherapy," said Dr. Peter G. Traber,President, Chief Executive Officer and Chief Medical Officer, GalectinTherapeutics. "This Phase 1B clinical trial is a significant step ininvestigating a new treatment option for advanced melanoma, the most deadlyform of skin cancer."GR-MD-02 is Galectin Therapeutics' proprietary molecule that binds to andinhibits galectin proteins, predominantly galectin-3. A preclinical study ledby tumor immunology expert William L. Redmond, Ph.D., of EACRI found thatGR-MD-02 increased tumor shrinkage and enhanced survival in immune competentmice with prostate and breast cancers when combined with one of the immunecheckpoint inhibitors, anti-CTLA-4 or anti-PD-1. These findings suggest a rolefor GR-MD-02 in cancer immunotherapy."Dr. Redmond's preclinical work suggests a role for GR-MD-02 in cancerimmunotherapy," said Dr. Curti, the trial's principal investigator, a medicaloncologist and director of the Providence Biotherapy Program at EACRI. "ThisPhase 1B trial will build on this momentum and significantly contribute to ourscientific understanding of the effects of GR-MD-02 in combination withipilimumab in metastatic melanoma."Galectin Therapeutics is providing its proprietary compound GR-MD-02 to EACRIresearchers, as well as supplying researchers with supporting analysis of thepharmacokinetics of GR-MD-02 and the right to reference the Company's open INDon GR-MD-02.YERVOY ® is a registered trademark of Bristol-Myers Squibb Company.