Hovon Researchers to Study GlycoMimetics' GMI-1271 and Decitabine in Patients with AML and MDS.
M2 PHARMA-February 12, 2018-Hovon Researchers to Study GlycoMimetics' GMI-1271 and Decitabine in Patients with AML and MDS
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- Rockville, Maryland-based biotechnology company GlycoMimetics, Inc. (NASDAQ: GLYC) has entered into an agreement with the Dutch-Belgian cooperative clinical trial group Haemato Oncology Foundation for Adults in the Netherlands (Hovon) to initiate clinical trial startup activities in which Hovon researchers will evaluate GlycoMimetics' drug candidate, GMI-1271, in adults with newly diagnosed acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy, as well as in patients with myelodysplastic syndrome (MDS) with a high risk of leukemia, the company said.
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.
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.
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.
GMI-1271 is designed to block E-selectin, an adhesion molecule on cells in the bone marrow, from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.
Hovon's focus is in hematology oncology, with a clinical development program in leukemia, malignant lymphomas, and multiple myeloma.
Hospitals in the Netherlands participate in Hovon trials, and each hospital is in contact with a consultant affiliated to a hematological intensive care center participating in Hovon. In addition, the group works with several other countries in Europe.
GlycoMimetics is focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role.
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|Date:||Feb 12, 2018|
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