GlycoMimetics, Inc., a clinical stage biotechnology company, focuses on the discovery and development of glycomimetic drugs to address unmet medical needs resulting from diseases in the United States. The company is developing its lead product candidates include rivipansel, a pan-selectin antagonist, which is in Phase III clinical trials for the treatment of vaso-occlusive crisis, a debilitating and painful condition that occurs periodically throughout the life of a person with sickle cell disease; and GMI-1271, an E-selectin antagonist to treat acute myeloid leukemia and other hematologic cancers. Its GMI-1359, a combined CXCR4 and E-selectin antagonist, being readied for the clinical devel...
9708 Medical Center Drive
Rockville, MD 20850
Founded in 2003
GlycoMimetics, Inc. Doses First Patient in Phase 2 Portion of Clinical Trial of GMI-1271 in Newly Diagnosed Acute Myeloid Leukemia
Jun 28 16
GlycoMimetics, Inc. announced dosing of the first patient with newly diagnosed acute myeloid leukemia (AML) in the Phase 2 portion of its ongoing Phase 1/2 study evaluating its novel E-selectin antagonist, GMI-1271, combined with chemotherapy. Earlier this month, the company announced it had received Fast Track designation from the U.S. Food and Drug Administration (FDA) for GMI-1271 for treatment of adult patients with relapsed or refractory AML and elderly patients aged 60 years or older with AML. In addition, GlycoMimeticsrecently announced that the first patient with relapsed or refractory AML has been dosed in the other arm of the Phase 2 portion of this study. 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. 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. 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 the United States, Ireland, and Australia. While the primary objective is to assess safety, additional endpoints include overall response rate, biomarkers of activity, durability of response and overall survival. This Phase 2 portion of the study in newly diagnosed patients is expected to include approximately 25 participants.
GlycoMimetics, Inc.(NasdaqGM:GLYC) added to Russell 2000 Index
Jun 27 16
GlycoMimetics, Inc. has been added to Russell 2000 Index.
GlycoMimetics, Inc.(NasdaqGM:GLYC) added to Russell 3000 Index
Jun 27 16
GlycoMimetics, Inc. has been added to Russell 3000 Index.