>>BRISBANE, Calif., Jan. 16 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - news) announced today that the Data Safety Monitoring Board (DSMB) for the Company's Phase III clinical trial of Actimmune® (Interferon gamma-1b) injection for the treatment of idiopathic pulmonary fibrosis (IPF) recommended that InterMune continue the study as currently designed. The DSMB's recommendation to maintain the current sample size of the 330-patient study was based upon a one-time, pre-specified sample-size analysis.
In addition, the Company reported that approximately 65% of the trial is complete in terms of patient treatment days. Furthermore, less than 5% of patients have withdrawn from the study prior to meeting the primary endpoint. This strong retention rate is well within the assumptions underlying the statistical power and sample size of the trial.
``We are very pleased by the strong status of our IPF Phase III trial,'' said W. Scott Harkonen, M.D., President and Chief Executive Officer of InterMune. ``As a result of both the DSMB analysis and current patient retention rate, we are confident that we are on track to complete the trial in August 2002 and to announce results of the study by November 2002.''
IPF is a debilitating and usually fatal treatment for which there is no effective therapy. The disease is characterized by progressive scarring, or fibrosis of the lungs, which ultimately leads to respiratory failure. The prognosis is poor for patients with IPF and the median life span is three to five years from the time of diagnosis. There are approximately 50,000 patients in the United States suffering from IPF, which occurs primarily in persons 40 to 70 years old. Actimmune is the first and only drug to have shown promise as a treatment for IPF in a Phase II clinical trial.<<
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