GlycoMimetics Inc. announced that the first healthy volunteer has been dosed in a Phase 1 clinical study designed to evaluate the safety, tolerability and pharmacokinetics of GMI-1271, a novel and proprietary E-selectin antagonist in the company’s pipeline. GlycoMimetics is initially exploring the clinical use of the drug candidate to treat acute myeloid leukemia (AML) following preclinical studies of GMI-1271 for blood cancers and other cancers that are associated with elevated risk of metastasis and thrombosis.
“We have demonstrated a very attractive preclinical profile for GMI-1271, with research findings substantiating the focus on E-selectin as a potential target for blood-related malignancies and for solid tumors at risk of metastasis,” said Helen Thackray, vice president of Clinical Development and Chief Medical Officer at GlycoMimetics. “Advancing this compound into clinical testing marks a significant milestone for GlycoMimetics. We believe that GMI-1271 has the potential to be an important new therapy for people with certain blood cancers as well as for those with high risk of metastasis in certain solid tumors.”
This single-site Phase 1 trial of GMI-1271, is a randomized, double-blind, placebo-controlled, single ascending intravenous dose study designed to evaluate the safety, tolerability and pharmacokinetics of GMI-1271 in 28 healthy adult subjects (three dose levels will be tested). The company anticipates final data being available in the second half of 2014. The company’s next planned study is a Phase 1/2 trial of GMI-1271 as an adjunct to standard chemotherapy in patients with AML.
Date: June 19, 2014