![]() The Kaplan Meier estimate of survival at five years was 77.8% andġ6.7% in the Actimmune and control groups, respectively (p = 0.009). Open-label trial of Actimmune, in which 16 patients received one or more doses of Actimmune following study completion. Well tolerated with the most common side effects reported being flu-like symptoms.ĭata appear to confirm long-term follow-up data, reported earlier this year at the ATS meeting, which involved 18 patients from a randomized, controlled, Were also trends later in the course of the study in favor of Actimmune in terms of improved breathing (i.e., dyspnea) and reduced need for supplemental oxygen. The placebo group (16.4%), representing a 70% decrease in mortality in favor of Actimmune versus placebo (p = 0.004). Further, of the 254 patients with mild to moderate disease (FVC >= 55 percent), there were 6/126 deaths in the Actimmune-treated group In the overall population, there were 16/162 deaths in the Actimmune-treated group (9.9%) compared to 28/168 deaths in the placebo group (16.7%), representing a 40% decrease in mortality While this endpoint did not reach statistical significance, there was a trend in favor of Actimmune-treated patients, representing anĪpproximately 10% relative reduction in the rate of progression-free survival versus placebo.Īctimmune also demonstrated a strong positive trend in increased survival in the overall patient population, and a statistically significant survival benefit in patients with mild to The primaryĮndpoint was progression free survival time defined as either one of the following: (i) a decrease in forced vital capacity (FVC) of >10 percent, (ii) an increase inĪ-a gradient of 5 mmHg, or (iii) death. All patients remained in the trial until the last patient received 48 weeks of therapy. Of Actimmune injected subcutaneously three times per week. Patients received either placebo or 200 micrograms Total of 330 patients were randomized into this double-blind, placebo-controlled trial conducted at 58 centers around the United States and Europe. These results would indicate that Actimmune should be used early in the course of this disease in order to realize the most favorable long-term survival benefit." "Interferon gamma-1b is the first treatment ever to show any meaningful clinical impact in this disease in rigorous clinical trials, and Phase III study's lead principal investigator. Mortality benefit is very compelling and represents a major breakthrough in this difficult disease," said Ganesh Raghu, M.D., Professor of Medicine, University of Washington in Seattle, and the Use of Actimmune and lead to peak sales in the range of $400-$500 million per year, enabling us to achieve profitability in 2004 as planned." "Actimmune is the only available treatment demonstrated to have clinical benefit in IPF, with improved survival data in two controlled clinical trials. Scott Harkonen, M.D., President and CEO of EDT today to discuss these results (details below).Īre extremely pleased with these results, which indicate Actimmune may extend the lives of patients suffering from this debilitating disease," said W. There was alsoĪpproximately a 10% relative reduction in the rate of progression-free survival associated with Actimmune versus placebo, the trial's primary endpoint, but this was not a statisticallyĬompany will hold a conference call at 9:00 a.m. These data confirm the survival benefit seen in the Phase II trial presented earlier this year at the 98 th Annual Conference of the American Thoracic Society. (Nasdaq: ITMN) announced today that preliminary data from its Phase IIIĬlinical trial of Actimmune® (Interferon gamma-1b) injection for the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and usually fatal disease for which thereĪre no effective treatment options, demonstrate a significant survival benefit in patients with mild to moderate disease randomly assigned to Actimmune versus control treatment (p = 0.004). Reduces Mortality by 70% in Patients with Mild to Moderate DiseaseīRISBANE, Calif., August 28, 2002InterMune, Inc. Investor contact: Myesha Edwards, InterMune, Inc., 41, contact: Jim Weiss, InterMune, Inc., 41, ANNOUNCES PHASE III DATA DEMONSTRATING SURVIVAL BENEFIT OF ACTIMMUNE IN IPF QuickLinks - Click here to rapidly navigate through this document
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