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First Cohort Enrolled in GlycoMimetics' Phase 2 Clinical Trial of GMI-1271 in Newly Diagnosed AML.

M2 PHARMA-March 8, 2017-First Cohort Enrolled in GlycoMimetics' Phase 2 Clinical Trial of GMI-1271 in Newly Diagnosed AML


- The first of two patient cohorts has completed enrollment in US-based biotechnology company GlycoMimetics, Inc.'s (NASDAQ: GLYC) Phase 2 acute myeloid leukemia trial of GMI-1271, the company said.

This cohort is comprised of 25 patients 60 years of age or older with newly diagnosed AML.

The study is designed to evaluate the potential of GMI-1271, GlycoMimetics' E-selectin antagonist drug candidate, in combination with chemotherapy, as a treatment for patients with both newly diagnosed and relapsed/refractory AML.

Enrollment in the study's second arm is expected to complete in the middle of this year. The two arms combined will enroll a total of about 90 patients.

GMI-1271 data were presented in 2016 at meetings of the European Hematology Association and the American Society of Hematology, showing high remission rates and lower than expected 30- and 60-day mortality rates in early evaluations of patients with relapsed/refractory AML.

In addition to the ongoing Phase 1/2 trial, clinical investigators are currently evaluating GMI-1271 in an ongoing Phase 1 clinical trial in multiple myeloma. Preclinical data supporting the multiple myeloma study is scheduled to be shared in an oral presentation at the American Association of Cancer Research annual meeting 2017 in April.

Specifically, the newly announced preclinical results show a strong effect on cancer cells in combination with chemotherapy and are supportive of the ongoing Phase 1 clinical studies of GMI-1271 in multiple myeloma.

Acute myeloid leukemia is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults.

Each year in the United States, about 19,900 people (usually older than 45 years of age) are diagnosed, and about 10,400 people die from all forms of the disease, according to the American Cancer Society.

Unlike other cancers that start in an organ and spread to the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow, getting in the way of normal blood cell production.

The lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding).

Current treatment options for AML consist of reducing and eliminating cancer cells mainly through chemotherapy, radiation therapy, and stem cell transplantation.

GlycoMimetics is a clinical-stage biotechnology company focused on cancer and sickle cell disease. GlycoMimetics' most advanced drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer.

The company's wholly-owned drug candidate, GMI-1271, an E-selectin antagonist, is being evaluated in an ongoing Phase 1/2 clinical trial as a potential treatment for AML and in a Phase 1 clinical trial in multiple myeloma.

GlycoMimetics has also recently initiated a clinical trial with a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region.

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Publication:M2 Pharma
Date:Mar 8, 2017
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