University of Michigan to Study GlycoMimetics' GMI-1271 as Potential Treatment for Serious Blood-Clotting Disorder
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"We believe that GMI-1271 may have broad applications beyond acute
myeloid leukemia and other blood cancers. The U-M study of our drug
candidate as a potential treatment for a serious blood-clotting disorder
is an important example of a potential additional indication," said
U-M announced last December that the
This first U-M study of GMI-1271 is a randomized, partially blinded, active placebo-controlled trial expected to last approximately 10 months. The primary objective of the study is to evaluate the safety and PK profile of GMI-1271 in a Phase 1 single ascending dose (SAD) study in healthy volunteers. The secondary objectives include: 1) to evaluate the incidence of bleeding and other adverse events, and 2) to evaluate the effects of GMI-1271 on biomarkers of coagulation, cell adhesion and leukocyte and platelet activation.
"VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism
(PE), may affect up to 900,000 patients per year, with over 300,000
deaths per year in the U.S., and an increasing incidence as our
population ages," said
In
Preclinical data for GMI-1271 will be presented in four oral presentations during the 2014 ASH Annual Meeting this month, including one presentation entitled "E-Selectin Inhibitor GMI-1271 Works in Combination with Low-Molecular Weight Heparin to Decrease Venous Thrombosis and Bleeding Risk in a Mouse Model."
About VTE
VTE, which can happen after a major operation, or severe illness such as heart attack, stroke and some cancers, refers to both pulmonary embolism and deep vein thrombosis (DVT), blood clots that form in large veins of the legs. The clots become dangerous when they break loose and affect blood flow to the heart and lungs. A mainstay of VTE prevention and treatment are anticoagulants that reduce blood clotting, but the medicines are associated with a significant risk of hemorrhage and for the most part do not decrease the inflammation that comes with VTE. Based upon preclinical study with data presented at the 2012 ASH Annual Meeting ("Novel E-Selectin Antagonist GMI-1271 Decreases Venous Thrombosis without Increased Bleeding Potential in a Mouse Model"), it appears that GMI-1271 may lead to reduced bleeding risk and reduction in inflammation. Studies have shown that inflammation and thrombosis are interrelated, and that inflammation contributes to the thrombotic process.
About GMI-1271
E-selectin antagonist GMI-1271 has the potential to be used in
combination with chemotherapy to improve outcomes in cancer patients. It
is being evaluated to determine if it can improve response rates and
overall survival. It may also address both metastasis (cancer's spread)
and thromboembolic complications (those occurring when a blood vessel is
blocked by a blood clot dislodged from its site of origin).
About
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 on Forward-Looking Statements
The statements in this press release that are not historical facts
constitute "forward-looking statements" that involve risks and
uncertainties and are made pursuant to the Private Securities Litigation
Reform Act of 1995. These forward-looking statements may be identified
by their use of terms and phrases such as "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project,"
"target," "potential," "will," "would," "could," "should," "continue,"
and similar expressions, or the negative of such terms, and include, but
are not limited to, GlycoMimetics' expectations regarding potential
payments under its collaboration with Pfizer and its planned activities
with respect to the clinical development of GMI-1271. Actual results may
differ materially from those expressed or implied by these
forward-looking statements as a result of a number of 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" sections of the
company's quarterly Report on Form 10-Q that was filed with the
bhahn@glycomimetics.com
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