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GlycoMimetics, HOVON enter agreement to initiatie trial startup activities.

GlycoMimetics announced that it has entered into an agreement with the Haemato Oncology Foundation for Adults in the Netherlands group to initiate clinical trial startup activities. In the planned clinical trial, HOVON researchers will evaluate GlycoMimetics' drug candidate, GMI-1271, in adults with newly diagnosed acute myeloid leukemia but who cannot tolerate intensive chemotherapy, as well as in patients with myelodysplastic syndrome with a high risk of leukemia. The HOVON Central Office has already approved a protocol concept, and this agreement enables HOVON to commit staff to the planned trial in order to finalize the protocol, start regulatory and ethics reviews, and begin development of the database. Separately, GlycoMimetics said it plans to announce the design details for its company-sponsored Phase 3 trial in relapsed/refractory AML patients as part of its fourth-quarter and year-end 2017 earnings call scheduled for March 6, 2018. The HOVON trial will be the first to evaluate GMI-1271 together with decitabine in this underserved population of AML and MDS patients, who are not considered by their physicians to be candidates for intensive chemotherapy; these two populations represent a significant potential label expansion opportunity for GMI-1271. HOVON intends to enroll approximately 140 patients in the clinical trial, including a control arm. Key efficacy endpoints will include complete remission rate, disease-free survival, and overall survival. The trial is expected to start this year and will be conducted in five countries across Europe.

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Publication:The Fly
Date:Feb 8, 2018
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