Late last year Rockville, MD-based GlycoMimetics turned up at ASH to report out an early snapshot of some positive outcomes from the first stage of a Phase I/II study of GMI-1271, its E-selectin antagonist, for a small group of patients with acute myeloid leukemia. And with another batch of data being readied for ASCO in a couple of weeks, the biotech says that the FDA has helpfully provided a breakthrough drug designation to help them accelerate the development work through to a potential marketing application.
Now in the Phase II portion of the study, investigators for the company have been recruiting two groups of AML patients: Treatment resistant subjects and newly diagnosed patients over the age of 60. The drug is designed to target pathways tumors use to defend against therapies, heightening the effect of chemo.
Last December investigators noted that for 33 study participants with relapsed or refractory disease in one arm of the trial, the complete response rate was 45%. For 11 newly diagnosed study participants 60 or more years of age in the second arm of the trial, the CR rate was 73%.
BTD status for this therapy follows orphan and fast-track status from the FDA, which has been wide open to pushing through accelerated approvals in the oncology field, transforming development work for new cancer drugs.
“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,” said Helen Thackray, the CMO of GlycoMimetics, in a prepared statement. “We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for individuals living with AML.”
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