Glycomimetics, Inc. Announces First Patient with Advanced Breast Cancer Receives First Dose in Clinical Trial of GlycoMimetics' GMI-1359
January 30, 2020 at 09:00 am EST
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GlycoMimetics, Inc. announced that Duke University investigators have dosed the first patient in a proof-of-concept Phase 1b study to evaluate GlycoMimetics' novel GMI-1359 drug candidate in patients with advanced breast cancer. The dose-escalating study will enroll up to 12 individuals with metastatic, hormone receptor positive breast cancer with stable or minimally progressive disease, including bone metastasis. GMI-1359 is a dual inhibitor of both E-selectin and CXCR4. The trial is designed to evaluate safety, pharmacokinetics and pharmacodynamic measures of biologic activity, such as increases in circulating tumor cells and mobilization of CD34+ and immune T-cell subsets. GlycoMimetics expects the trial results to be available in late 2020, the conclusions of which the Company will use to inform future development of GMI-1359. Kelly Marcom, M.D., and Dorothy Sipkins, M.D., Ph.D., both of the Duke Cancer Institute, are the trial’s co-principal investigators. This clinical trial builds on published findings from Dr. Sipkins on the key roles of both E-selectin and CXCR4 in the trafficking of metastatic cancer cells and of their establishment as micro-metastases in bone. Dr. Sipkins’ research suggests that both E-selectin and CXCR4 mediate key mechanisms that promote progression and migration of cancer cells to protective niches in the bone marrow micro-environment, and reveals the potential for an E-selectin and CXCR4 inhibitor like GMI-1359 to molecularly excise disseminated breast cancer cells.
GlycoMimetics, Inc. is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML) and for inflammatory diseases. It is developing a pipeline of glycomimetics, which are small molecules that mimic the structure of carbohydrates involved in biological processes, to inhibit disease-related functions of carbohydrates, such as the roles they play in inflammation, cancer and infection. Its drug candidates include Uproleselan, GMI-1687, Galectin Antagonists and GMI-1359. It is developing Uproleselan, a specific E-selectin antagonist, to be used in combination with chemotherapy to treat patients with AML, a life-threatening hematologic cancer, and potentially other hematologic cancers. It has designed an antagonist of E-selectin, GMI-1687, that is suitable for subcutaneous administration. GMI-1359 is a drug candidate that simultaneously targets both E-selectin and a chemokine receptor (CXCR4).