BiotechTracker - Actimmune Data at the American Thoracic Society Meeting
May 16, 2003. InterMune’s (NASDAQ: ITMN) Actimmune continues to generate data that will rekindle debate over its clinical and commercial merit. We view its probability for use expansion followed by eventual label expansion into idiopathic pulmonary fibrosis (IPF) as moderately above average. At the American Thoracic Society (ATS) meeting beginning today in Seattle, the most important poster features data from phase III investigation designed to support label expansion into IPF. The study reinforces the idea that statistical and clinical significance can be uncoupled. The lower the number of incident, prevalent, or studied cases, the more likely are statistically insignificant trends to be clinically significant. Conversely, the greater the number of incident, prevalent, or studied cases, the less likely statistical significance conveys clinical significance. Given that magnitudes of therapeutic effects often drive use decisions more so than statistical significance, Actimmune’s therapeutic profile remains reassuring in IPF, especially for survival and to a lesser extent for disease progression. For real-world decision-making, clinicians are more likely to look at these magnitudes of effects (here measured as relative risk reductions), especially as Actimmune is already marketed for other indications. In spite of this positive outlook, an interesting observation from the data to be presented at the ATS meeting is that survival is preserved without an increase in quality of life, ability to breath more comfortably, or ability to decrease reliance on medicinal oxygen. The failure of the study to demonstrate that one’s life, although extended, gets considerably more appealing, is most likely an issue of use ceilings than it is of label expanding potential. The use of Actimmune to extend life without enhancing its quality or reducing specific medical resource burdens will only be acceptable to a limited population of patients, providers, and payors. Also at ATS, a small study from Greece reinforces Actimmune’s therapeutic effect profile, highlighting its potential to compete with colchicine / prednisone combination therapy. Two other posters demonstrate preliminary evidence of the feasibility and safety of aerosolized delivery of the product, including one with an Aradigm (NASDAQ: ARDM) delivery system. Clinical data include: Raghu et al published Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Interferon Gamma-1b (IFN- 1b) in Patients with Idiopathic Pulmonary Fibrosis (IPF) 330 study subjects randomized to Actimmune or placebo SQ thrice weekly for up to 3 years prespecified data cutoff for primary analysis = 48 wk after randomization of the 306th patient Actimmune provided clinically significant advantages in terms of death or disease progression – 46.3% versus 51.8% (11% relative reduction, p=0.53, lacking statistical significance) Actimmune provided clinically significant advantages in terms of death 9.9% versus 16.7% overall (41% relative reduction, p=0.08, lacking statistical significance) 3.3% versus 13.0% of less severely affected patients (forced vital capacity [FVC] > 60% at baseline) (p=0.02) 18.1% versus 21.1% of more severely affected patients (FVC < 60% at baseline)(p=0.75, lacking statistical significance) no significant effects were observed on other secondary endpoints quality of life dyspnea (shortness of breath) oxygen use gas diffusion parameters FVC Antoniou, et al will present Comparison of Interferon Gamma-1b (IFN-) and Colchicines in the Treatment of Idiopathic Pulmonary Fibrosis: Preliminary Results of a Prospective, Multicenter Randomized Study to determine if Actimmune offers a therapeutic advantage to colchicine plus prednisone, currently an option for IPF patients who are refractory to corticosteroids 44 patients randomized to either treatment arm median follow up = 15 months 1 death in the Actimmune group 2 deaths in colchicine / prednisone group 6-month endpoints 53% of patients improved, 30% remained stable, and 17% deteriorated in the Actimmune group 50% remained stable and 50% deteriorated in the colchicine / prednisone group Actimmune recipients tended to experience improved dyspnea (p=0.035) Blanchard heads an InterMune / Aradigm investigative team in the presentation of Lung Deposition of Interferon Gamma-1b Following Inhalation Via AERx System vs. Respirgard II Nebulizer studies the utility of AERx system aerosolization of Actimmune and pulmonary delivery of the drug as an alternative to today’s SQ route of administration randomized, 2-way, crossover study in 15 adults (versus a nebulized system) safety profile has included 5 mild-to-moderate adversities that are possibly related to treatment 1 with the AERx 4 with the nebulized system no severe adverse effects have been observed Kim, et al published Aerosol Interferon-Gamma Treatment in Idiopathic Pulmonary Fibrosis (IPF) 5 patients received Actimmune 500 mcg via nebulizer three times a week 3 patients had finished treatment at abstract submission 1 each demonstrated intra-lung evidence of successful anti-inflammatory effect at the cellular level, neutral effect, and inadequate effect tolerability profile was reassuring.
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