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news.Galectin Therapeutics has announced that the US Food and Drug Administration (FDA) has agreed that a Phase IB clinical trial of the galectin inhibitor GR-MD-02 in combination with Yervoy (ipilimumab) in patients with metastatic melanoma may proceed.
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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 IB study under principal investigator Dr Brendan D Curti. The study will employ a 3+3 Phase I 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.
Galectin Therapeutics president, CEO and chief medical officer Dr Peter G Traber noted 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.
"We expect the trial to begin enrollment in March. Future communications will outline expected milestone timings for the study," Dr Traber added.
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 Dr William L. Redmond 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.
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.
Yervoy is a registered trademark of Bristol-Myers Squibb.