GlycoMimetics Announces Positive Top-Line Results from Phase 1 Study of GMI-1271 in Healthy Volunteers
GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that healthy volunteers in a Phase 1 clinical study of GMI-1271 tolerated the drug candidate well, and that the pharmacokinetics for the drug candidate were as predicted based on preclinical data. The findings represent positive top-line results from a Phase 1 trial designed to evaluate the safety, tolerability and pharmacokinetics of GMI-1271, the GlycoMimetics-discovered novel and proprietary E-selectin antagonist. Based on these data, GlycoMimetics is planning a Phase 1/2 trial of GMI-1271 as an adjunct to standard chemotherapy in patients with acute myeloid leukemia (AML).
“Data from this Phase 1 study support moving GMI-1271 into a clinical trial to treat patients with AML. We anticipate that the first patient in that Phase 1/2 study will be dosed in the first quarter of 2015,” said Helen Thackray, M.D., Vice President of Clinical Development and Chief Medical Officer at GlycoMimetics.
The single-site Phase 1 trial of GMI-1271 was a randomized, double-blind, placebo-controlled, single ascending intravenous dose study that evaluated the safety, tolerability and pharmacokinetics of GMI-1271. Twenty-eight healthy adult subjects were enrolled in cohorts to receive study drug at three dose levels.
GlycoMimetics previously announced that preclinical data on GMI-1271 will be highlighted in four oral presentations and one poster presentation at the 2014 American Society of Hematology Annual Meeting in San Francisco in December 2014.
Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults, and it is estimated that there will be over 18,000 new cases and over 10,000 deaths from the disease in the U.S. in 2014. 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 and in most cases move into the blood, getting in the way of normal blood cell production. The lack of normal blood cells can cause some of the symptoms of acute myeloid leukemia, 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.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. Pfizer is the company’s development partner for rivipansel, a GlycoMimetics-discovered investigational therapy for pain crisis associated with sickle cell disease, and is preparing to conduct a Phase 3 clinical study. A GlycoMimetics wholly-owned candidate therapy (GMI-1271) for acute myeloid leukemia (AML) and other blood disorders is also in clinical trials. Glycomimetics are molecules that mimic the structure of carbohydrates involved in important biological processes. Using its expertise in carbohydrate chemistry and knowledge of carbohydrate biology, GlycoMimetics is developing a pipeline of glycomimetic drug candidates that inhibit disease-related functions of carbohydrates, such as the roles they play in inflammation, cancer and infection. Learn more at www.glycomimetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the clinical development of GMI-1271. Actual results may differ materially from those in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company’s quarterly report on Form 10-Q that was filed with the U.S. Securities and Exchange Commission on October 31, 2014, and other filings the Company makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.
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