Novartis PAH Glivec trial misses Ph II endpoint

Basel, Switzerland-headquartered Novartis presented data from a Phase II proof-of-concept study for Glivec/Gleevec (imatinib) in the treatment of pulmonary arterial hypertension that failed to meet its primary endpoint, at the European Respiratory Society conference in Berlin, Germany.

The trial was a 59-patient, multicenter, double-blind, placebo-controlled clinical evaluation of imatinib 400mg in patients who had previously failed to respond to standard therapy with prostanoids, endothelin antagonists or PDE-5 inhibitors. Improvements in the six-minute walk test, the primary endpoint of the study, approached, but did not reach, statistical significance.