Novartis pursues pulmonary hypertension indication for Glivec
pharmafile | October 10, 2008 | News story | Sales and Marketing |
Novartis says new data on Glivec shows it has potential to treat a life-threatening heart condition, despite failing to meet the trial's primary endpoint.
Early data from an exploratory study suggested patients suffering from pulmonary arterial hypertension (PAH) showed clinical improvement after treatment with Glivec (imatinib).
But the drug did not reach the trial's primary endpoint – to show an improvement in the six-minute walk test.
Despite this, Novartis will further explore its potential in PAH, which is an incurable blood vessel disease where current treatment options are limited.
Chief executive of Novartis Oncology David Epstein said: "There is a high unmet need for new treatments that address the underlying mechanisms of PAH. These early findings support exploring the potential of imatinib in PAH in a larger randomised clinical trial."
Preliminary results from phase II trials involving 59 patients showed Glivec had a beneficial effect on two areas used to monitor disease progression – pulmonary vascular resistance and cardiac output, but the improvements narrowly failed to reach statistical significance.
Undeterred Professor Ardeschir Ghofrani, head of the Pulmonary Hypertension Division at University Hospital Giessen und Marburg, said the trial suggested Glivec holds promise as a treatment for PAH.
"The outcomes of this trial are clinically important given the rapid progression of PAH and the poor prognosis for these patients," Prof Ghofrani added.
PAH involves a marked and sustained increase in blood pressure in the pulmonary artery, and affects up to 260,000 people worldwide.
There is no known cure and the prognosis for many PAH patients is similarly to that of some advanced cancers, with a five-year survival rate of 50%.
Glivec is currently licensed in the EU and US to treat all phases of Philadelphia-chromosome-positive chronic myeloid leukaemia, and as a treatment for gastrointestinal tumours.
Novartis had been conducting early-stage research with Glivec into another non-oncology disease called idiopathic pulmonary fibrosis (IPF), a condition where the lungs become scarred over time making it increasingly difficult to breathe.
But early trial results for this indication didn't show a significant benefit for Glivec over a placebo, and clinical trials have been halted.
