GlycoMimetics Doses First Patient in Phase 2 Portion of GMI-1271 Clinical Trial in Relapsed/Refractory Acute Myeloid Leukemia
For the study's Phase 2 portion, the optimal dose has been determined, and clinical investigators will expand the number of patients receiving GMI-1271 to obtain additional safety and efficacy data. Study enrollment is limited to patients at least 18 years old with relapsed or refractory AML and who would be treated with mitoxantrone, etoposide, and cytarabine (‘MEC'). All patients must be eligible to receive this chemotherapy regimen, and will be given GMI-1271 in addition to this combination chemotherapy. During the Phase 1 portion of the study, patients received a single cycle of treatment including GMI-1271. During this Phase 2 portion, certain patients will be eligible to receive an additional cycle of treatment.
"The data from the first cohorts point to both the safety and potential
efficacy of GMI-1271 as a treatment for AML," said
This clinical trial is a multinational open-label study evaluating
endpoints for safety, pharmacokinetics (PK) and efficacy of GMI-1271 in
combination with induction chemotherapy in patients with high-risk AML.
This trial is being conducted at a number of academic medical
institutions in
About GMI-1271
GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with AML 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 using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.
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