INTERMUNE DISCONTINUES STUDY OF ACTIMMUNE FOR IPF

InterMune has discontinued its Phase III INSPIRE clinical trial evaluating Actimmune in patients with idiopathic pulmonary fibrosis (IPF) based on the recommendation of the study's independent data monitoring committee (DMC).

In a planned interim analysis that included a total of 115 deaths, the DMC found the overall survival result crossed a predefined stopping boundary for lack of benefit of Actimmune (interferon gamma-1b) relative to placebo, InterMune said. Among the 826 randomized patients, there was not a statistically significant difference between treatment groups in overall mortality (14.5 percent in the Actimmune group compared with 12.7 percent in the placebo group). Based on a preliminary review of the interim safety data, the adverse events associated with Actimmune therapy appear generally consistent with prior clinical experience, including constitutional symptoms, neutropenia and possibly pneumonia.

INSPIRE was a double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Actimmune in IPF patients with mild to moderate impairment in lung function. The primary endpoint was survival time. The lack-of-benefit stopping boundary was developed to allow for early study termination if interim data were statistically inconsistent with a clinically meaningful treatment effect of Actimmune. InterMune said it plans to submit the data from the trial for presentation at an appropriate medical meeting and for publication in a peer-reviewed journal.

Actimmune is a synthesized version of interferon gamma, a naturally occurring protein believed to stimulate the immune system. InterMune currently markets Actimmune for the treatment of chronic granulomatous disease and severe, malignant osteopetrosis.