GlycoMimetics has announced the dosing of the first patient in a Phase Ib clinical trial to assess GMI-1359 for the treatment of advanced breast cancer.
The trial is being conducted at Duke University.
Designed to target tumour and bone marrow microenvironment, GMI-1359 is a dual inhibitor of E-selectin and CXCR4, which are adhesion molecules linked to tumour trafficking and metastasis.
According to preclinical findings, inhibition of E-selectin and CXCR4 with one compound could improve efficacy in some cancer types, including breast and prostate.
GMI-1359 was previously studied in a Phase I trial in healthy volunteers.
The new Phase Ib trial is designed to determine an effective dose of GMI-1359 and obtain initial biomarker data on its activity.
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It will assess the drug candidate’s safety, pharmacokinetics, and pharmacodynamics in up to 12 metastatic, hormone receptor-positive breast cancer patients with stable or minimally progressive cancer, including bone metastasis.
GlycoMimetics Clinical Development senior vice-president and chief medical officer Helen Thackray said: “The initiation of enrolment is an important milestone in our exploration of GMI-1359 and its potential as a novel approach to treating metastatic cancer.
“We’re pleased to have such distinguished researchers at Duke University begin to explore the use of this investigational therapy and look forward to learning more about its potential impact as clinical study advances.”
The company is set to report data from the Phase Ib trial later this year. This data is expected to inform the future development of the drug candidate.
Last April, GlycoMimetics started dosing in a Phase III study to evaluate uproleselan (GMI-1271) for the treatment of adults with acute myeloid leukaemia (AML). Uproleselan is designed to block E-selectin from binding with blood cancer cells.