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Clinical Trials

Date: 2016-09-14

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: GlycoMimetics (USA - Md)

Product: GMI-1271

Action mechanism: E-selectin antagonist. GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with acute myeloid leukemia cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug's potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies, mice with multiple myeloma that were treated with GMI-1271 and bortezomib showed improvement in survival compared to those treated with bortezomib alone. Furthermore, in mice with myeloma resistant to treatment with bortezomib, addition of GMI-1271 restored bortezomib sensitivity. In addition, blood samples from individuals with multiple myeloma showed increases in cell surface expression of E-selectin carbohydrate ligands when cancer had relapsed, indicating E-selectin as a promising target for reducing drug resistance in certain groups of patients who have the disease.

Disease: multiple myeloma

Therapeutic area: Cancer - Oncology

Country: Ireland

Trial details: This study will measure the efficacy, safety and pharmacokinetics of GMI-1271 in combination with chemotherapy among patients who have been diagnosed with multiple myeloma and have not responded well to standard chemotherapy.(NCT02811822)

Latest news:

  • • On September 14, 2016, GlycoMimetics announced it has dosed its first patient in a Phase 1 clinical trial of its E-selectin antagonist, GMI-1271, combined with bortezomib-based chemotherapy, for multiple myeloma. The company anticipates enrolling 24 participants in the trial.
  • The trial marks a second application for GMI-1271, which already is undergoing clinical study as a potential treatment for acute myeloid leukemia.
  • In the Phase 1 study, participants will include individuals who have been diagnosed with multiple myeloma and undergone bortezomib-based therapy with inadequate responses. The patients will receive one of four doses of GMI-1271 in combination with bortezomib, intravenously concurrently with bortezomib treatment. They will be followed after treatment to measure safety endpoints and efficacy.

Is general: Yes