This article is more than 5 years old. Information may no longer be current.
FDA grants breakthrough therapy designation to GMI-1271 for AML
Click Here to Manage Email Alerts
The FDA granted breakthrough therapy designation to GMI-1271 for the treatment of adults with relapsed or refractory acute myeloid leukemia, according to the agent’s manufacturer.
GMI-1271 (GlycoMimetics), a novel and proprietary E-selectin antagonist, is being evaluated in the phase 2 portion of an ongoing phase 1/phase 2 trial designed to assess the drug in combination with chemotherapy for patients with relapsed or refractory AML, and for patients aged 60 years or older with newly diagnosed disease.
Early evaluations of both groups showed patients treated with GMI-1271 achieved higher-than-expected remission rates, as well as lower-than-expected 30- and 60-day mortality rates, according to a company-issued press release.
The phase 2 portion of the trial completed enrollment in March.
GlycoMimetics will present additional data from both patient populations at the ASCO Annual Meeting, which will be held June 2-6 in Chicago.
“The FDA’s granting to GMI-1271 of breakthrough therapy designation will further help GlycoMimetics to accelerate the development of GMI-1271 as a treatment for this very difficult-to-treat patient population,” Helen Thackray, MD, chief medical officer of GlycoMimetics, said in the release. “We believe GMI-1271, when combined with chemotherapy, has the potential to address an unmet therapeutic need for individuals living with AML. We are encouraged by our clinical results to date, and look forward to working closely with the FDA to bring this novel therapy to patients as quickly as possible.”
The FDA previously granted orphan drug designation and fast track status to GMI-1271 for this indication.