GlycoMimetics begins Phase I/II trial of GMI-1271 to treat AML

The trial is designed to evaluate the safety, pharmacokinetics (PK) and efficacy of GMI-1271 when used in combination with chemotherapy in AML patients.

Initially, the company is exploring the clinical use of the drug candidate in hematologic malignancies following the successful completion of a Phase I healthy volunteer trial late last year.

Earlier this month, the company secured orphan drug designation from the US Food and Drug Administration (FDA) for GMI-1271 to treat AML.

GlycoMimetics vice-president of Clinical Development and chief medical officer Helen Thackray said: "We have demonstrated a very attractive preclinical profile for GMI-1271, with research findings presented through four oral presentations and a poster at the 56th ASH Annual Meeting in December 2014.

"These data substantiate the focus on E-selectin as a potential target for blood-related malignancies and for solid tumors at risk of metastasis.

"Based on our preclinical data and on a benign safety profile in Phase I, we believe that GMI-1271 has the potential to be an important new therapy for people with certain blood cancers."

This open-label multicenter Phase I/II trial is designed to determine safety, PK and efficacy of GMI-1271 in combination with chemotherapy in male and female adult patients with AML.

Around 77 subjects will be enrolled at trial sites are located in the US, Australia and Ireland.

The trial’s primary objective is to analyze safety, additional endpoints including mobilization of AML blasts, effect on neutropenia, time to and duration of remission, evaluation of event-free survival and evaluation of the overall survival probability at six- and 12-months.