GAITHERSBURG, Md. — GlycoMimetics Inc. (Nasdaq: GLYC) announced that the University of Michigan has dosed the first healthy volunteer in a Phase 1 clinical trial of GMI-1271, a cancer drug that is now being tested to treat a blood-clotting disorder that produces life-threatening blood clots in the legs and lungs.
“We believe that GMI-1271 may have broad applications beyond acute myeloid leukemia and other blood cancers,” said Helen Thackeray, M.D., vice president of clinical developemnt and chief medical officer of GlycoMimetics. “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. Since thrombosis is also a problem in many cancer patients, this study will complement our evaluation of GMI-1271 in hematologic malignancies.”
UM announced a year ago that the National Institutes of Health’s National Heart Lung and Blood Institute had awarded the university $1.7 million to collaborate with GlycoMimetics to study GMI-1271 as a potential new class of anticoagulant to help millions of Americans at risk for a blood-clotting disorder called venous thromboembolic disease. The goal of the grant is to evaluate potential therapies that could treat and prevent blood clots with reduced risk of bleeding. Suman Sood, M.D., a hematologist at the UM Comprehensive Cancer Center, and Thomas Wakefield, M.D., head of vascular surgery at the UM Frankel Cardiovascular Center, are co-principal investigators of the study.
This first UM 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 the movement within the body of GMI-1271 in a Phase 1 single ascending dose study in healthy volunteers. Secondary objectives include evaluating the incidence of bleeding and other adverse events, and to evaluate the effects of GMI-1271 on biomarkers of coagulation, cell adhesion and leukocyte and platelet activation.
Sood noted that VTE includes deep vein thrombosis and pulmonary embolism, and may affect up to 900,000 patients per year in the United States alone, with over 300,000 deaths per year. He added that there’s an increasing frequency of VTE as the population ages.
“Given that current treatment options for VTE are far from perfect, this clinical study and further evaluation of GMI-1271 as a potential new treatment option are very important for both the medical community and the people who may face the threat of VTE,” Sood said.
In November 2014, GlycoMimetics announced that it had completed the first Phase 1 trial with GMI-1271 in healthy volunteers. The company is initially exploring clinical use of the drug candidate to treat acute myeloid leukemia following preclinical studies of GMI-1271 for blood cancers and other cancers that are associated with elevated risk of metastasis and thrombosis. The company’s next planned study is a Phase 1 and 2 trial of GMI-1271 as an adjunct to standard chemotherapy in patients with AML.
VTE can happen after a major operation, or severe illness such as heart attack, stroke and some cancers. It refers to both pulmonary embolism and deep vein thrombosis, 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 a 2012 medical conkference, 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.
The 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). GlycoMimetics selected AML as the initial target disease indication for the compound and announced the completion of the first Phase 1 clinical study during November of 2014. GlycoMimetics has conducted preclinical studies to explore the compound’s use in blood cancers and other cancers that are also associated with elevated risk of metastasis and thrombosis.
More at www.glycomimetics.com.