>>BRISBANE, Calif., March 30 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced the publication of results from an exploratory Phase II clinical trial investigating the effects of Actimmune® (interferon gamma-1b) on the expression of biological markers associated with idiopathic pulmonary fibrosis (IPF), a disease characterized by progressive scarring or fibrosis of the lungs, which ultimately results in death.
The results provide clues to the molecular mechanisms through which interferon gamma-1b may affect patients with IPF. The study will be published in the American Journal of Respiratory and Critical Care Medicine. The paper has been published, ahead of print, on the Journal's website at www.ajrccm.atsjournals.org.
"This is the first study to provide evidence in humans that interferon gamma-1b alters expression of blood and lung biomarkers considered to play a central role in the pathogenesis of IPF," said lead author Robert M. Strieter, M.D., Professor of Medicine and Pathology, Chief, Division of Pulmonary and Critical Care Medicine, and Vice Chair of the Department of Medicine at the David Geffen School of Medicine at University of California Los Angeles. "This study suggests that mortality in these patients could potentially be altered by interferon gamma-1b through multiple mechanisms of action and therefore may support its potential utility for the treatment of IPF."
The goal of the trial was to gain insight on the effects of interferon gamma-1b on multiple disease pathways believed to be involved in IPF disease progression, including fibrosis, angiogenesis, inflammation and antimicrobial defense.
The randomized, double blind, placebo-controlled Phase II clinical trial enrolled 32 IPF patients at 15 medical centers across the United States. Patients received either 200 micrograms of interferon gamma-1b subcutaneously three times weekly, or placebo, for six months.
The primary endpoints were changes in mRNA gene expression for the growth factors, transforming growth factor-beta (TGF-beta) and connective tissue growth factor (CTGF). Other endpoints in the study included changes in mRNA and protein biomarkers for profibrotic molecules, cytokines, chemokines, antimicrobial peptides and additional growth factors, clinical measures of lung function and patient safety.
After treatment for six months with interferon gamma-1b, no significant difference was observed for the changes in mRNA transcription levels for TGF-beta and CTGF. Synthesis of I-TAC/CXCL11, a CXC chemokine with known immunomodulatory, antimicrobial, and anti-angiogenic properties was markedly increased. Interferon gamma-1b appeared to influence a number of biomarkers that may be relevant in the pathogenesis of IPF. No statistically significant changes were observed in clinical measures of lung function. Interferon gamma-1b was generally well-tolerated. Side effects were consistent with flu-like symptoms.
Financial support for this study was provided by InterMune, Inc and a National Institutes of Health Specialized Centers of Research grant (HL67665).
About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is the most common form of idiopathic interstitial pneumonia, affecting approximately 83,000 people in the United States alone. Median survival time is two to five years after diagnosis in patients with IPF. Once symptoms appear, there is a relentless deterioration of pulmonary function. Early symptoms of IPF are usually similar to those of other lung diseases. Very often, for example, patients suffer from a dry cough and dyspnea (shortness of breath). As the disease progresses, dyspnea becomes the major problem. Day-to-day activities such as climbing stairs, walking short distances, dressing, and even talking on the phone and eating become more difficult and sometimes nearly impossible. The patient may also become less able to fight infection. IPF results in scarring, or fibrosis, of the lungs. Most cases of IPF are diagnosed between the ages of 40 and 70. There are currently no drugs approved by the FDA for the treatment of IPF.<<
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