Clinical-stage biotechnology firm GlycoMimetics has commenced a Phase I/II clinical trial, which has been designed to assess the safety, pharmacokinetics (PK) and efficacy of the new E-selectin antagonist, GMI-1271, for acute myeloid leukaemia (AML).
The company has enrolled first patient in the multicentre study, which will determine safety, PK and efficacy of GMI-1271 in combination with chemotherapy in male and female adult patients with AML.
GlycoMimetics had completed a Phase I healthy volunteer study of the drug in late 2014. The US Food & Drug Administration (FDA) granted orphan drug status to GMI-1271 to treat AML.
GlycoMimetics chief medical officer and clinical development vice-president Dr 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 tumours at risk of metastasis."
The company will enrol around 77 patients in the study that is being carried out in the US, Australia and Ireland.
The primary objective of the study is to analyse safety and additional endpoints comprise mobilisation 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.
According to the company, the trial will comprise dose escalation phase followed by expansion of the study once the dose for the Phase II portion has been selected.
Image: Bone marrow aspirate showing acute myeloid leukaemia. Photo: courtesy of VashiDonsk.