GlycoMimetics Completes Enrollment of Newly Diagnosed AML Patient Cohort in Phase 2 Clinical Trial of GMI-1271

On March 7, 2017 GlycoMimetics, Inc. (NASDAQ:GLYC) reported that the first of two patient cohorts in its Phase 2 acute myeloid leukemia (AML) trial of GMI-1271 has completed enrollment (Press release, GlycoMimetics, MAR 7, 2017, View Source [SID1234518028]). 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.

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"At the ASH (Free ASH Whitepaper) meeting in December, we showed that GMI-1271 was well-tolerated and demonstrated a high remission rate among the patient volunteers who were enrolled early in the study," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. "We are enthusiastic about that data, and as such, we look forward to opportunities later in the year to report initial treatment outcomes for this study."

GMI-1271 data were presented in 2016 at meetings of the European Hematology Association (EHA) (Free EHA Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper), 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 (AACR) (Free AACR Whitepaper) 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.

About AML

Acute myeloid leukemia (AML) 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.