USA-based drug major Merck & Co has suspended enrollment in clinical trials of its lead investigational Aurora kinase inhibitor MK-0457 (VX-680), which was licensed from collaborator Vertex Pharmaceuticals, pending a full analysis of all efficacy and safety data. The decision was based on preliminary safety findings of QTc prolongation in one patient. The two firms have a broad R&D program underway to evaluate Aurora kinase inhibitors as novel approaches to targeted cancer treatment. As part of Merck's strategy to develop multiple drug candidates in different tumor types and treatment combinations, the drug major plans to initiate a Phase I trial of VX-689 in patients with advanced and/or refractory solid tumors in early 2008. MK-0457 is being investigated in a Phase II trial in treatment-refractory chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia with the T315I mutation, as well as an ongoing Phase I clinical study in advanced leukemias. Patients currently enrolled in these trials may continue to be treated with MK-0457, with additional monitoring for QTc prolongation, Merck noted.
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