GlycoMimetics Doses First Patient in Phase 2 Portion of Clinical Trial of GMI-1271 in Newly Diagnosed Acute Myeloid Leukemia
For the study's Phase 2 portion, the optimal dose of GMI-1271 has been determined, and in this arm of the study clinical investigators will study the effects on newly diagnosed patients receiving the drug candidate to obtain additional safety and efficacy data. Study enrollment in this arm is limited to patients at least 60 years of age who have been newly diagnosed with AML and are eligible to receive treatment with the chemotherapy agents cytarabine and idarubicin (‘7+3'). All patients must be eligible to receive this intensive 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 additional cycles 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.
About
Forward-Looking Statements
This press release contains forward-looking statements regarding
GlycoMimetics' planned activities with respect to the clinical
development of its drug candidate GMI-1271. Actual results may differ
materially from those indicated by such forward-looking statements as a
result of various important factors, including the availability and
timing of data from ongoing clinical trials, the uncertainties inherent
in the initiation of future clinical trials, whether interim results
from a clinical trial will be predictive of the final results of the
trial or results of early clinical trials will be indicative of the
results of future trials, expectations for regulatory approvals,
availability of funding sufficient for GlycoMimetics' foreseeable and
unforeseeable operating expenses and capital expenditure requirements,
other matters that could affect the availability or commercial potential
of GlycoMimetics' drug candidates and other factors discussed in the
"Risk Factors" section of GlycoMimetics' Annual Report on Form 10-K that
was filed with the
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