(Adds details on trial, drugs, halted development of MK-6592)
LOS ANGELES Nov 20 Vertex Pharmaceuticals Inc
(VRTX.O) said Merck & Co Inc (MRK.N) halted enrollment on
trials of their investigational leukemia drug MK-0457 due to a
potential heart safety issue in one patient.
Vertex and Merck said they suspended trials involving
MK-0457, also known as VX-680, pending a full analysis of
efficacy and safety data after preliminary data showed that one
patient experienced QTc prolongation.
QTc prolongation is a disorder of the heart's electrical
system that can result in an irregular heartbeat and is
associated with increased risk of sudden cardiac death.
MK-0457 is the lead Aurora kinase inhibitor drug from the
companies' development collaboration.
The drug is being studied in a Phase 2 trial in patients
with treatment-resistant chronic myelogenous leukemia, or
Philadelphia chromosome-positive acute lymphoblastic leukemia.
The companies also suspended a newly launched Phase 1 trial
of MK-0457 in combination with dasatinib in those same patient
MK-0457 is also being studied in an ongoing Phase 1 trial
in patients with advanced leukemias.
Vertex and Merck said patients currently enrolled in trials
may continue to be treated with MK-0457, with additional
monitoring for QTc prolongation.
The companies also said they discontinued development of
their Aurora kinase inhibitor MK-6592, or VX-667, after the
investigational drug failed to meet pharmacokinetic objectives
in a Phase 1 trial.
(Reporting by Lisa Baertlein; editing by Braden Reddall and