GlycoMimetics has dosed the first patient in a Phase III clinical trial to evaluate uproleselan (GMI-1271) for the treatment of adults with acute myeloid leukaemia (AML).
The trial is the second in a series of trials designed to evaluate uproleselan. It is being conducted under the support of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI).
In November last year, GlycoMimetics dosed the first patient in the initial Phase III clinical trial to evaluate uproleselan in combination with mitoxantrone, etoposide and ara-C (MEC) or fludarabine, ara-C and idarubicin (FAI).
Sponsored by NCI, the latest trial is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML.
The European HOVON consortium is planning to conduct a third trial, which is expected to initiate later this year.
GlycoMimetics Clinical Development senior vice-president and chief medical officer Helen Thackray said: “The initiation of the NCI-sponsored trial is an important milestone for our uproleselan programme, a drug candidate with the potential to address significant unmet treatment needs across the spectrum of AML.
“Along with our global pivotal Phase III clinical trial testing the investigational drug in patients with relapsed/refractory acute myeloid leukemia, this trial will facilitate our growing understanding of how uproleselan may fit into the continuum of care for individuals living with AML.”
GlycoMimetics will conduct the trial in partnership with the NCI and the Alliance for Clinical Trials in Oncology.
The trial’s primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after enrolment of the first 250 patients in the study.
Uproleselan has been designed to block E-selectin from binding with blood cancer cells and was evaluated in a Phase I/II clinical trial in both newly diagnosed elderly and relapsed / refractory patients with AML.
The E-selectin inhibitor secured a Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of adult AML patients with relapsed/refractory (R/R) disease.