>>BRISBANE, Calif., Dec. 16 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that consistent with previous guidance the first patient has been enrolled into the INSPIRE Trial, its pivotal Phase III trial evaluating the efficacy and safety of Actimmune® (interferon gamma-1b) as a treatment for idiopathic pulmonary fibrosis (IPF), a debilitating and deadly lung disease.
Approximately 83,000 patients suffer from this disease in the United States alone. There are currently no drugs approved by the FDA for the treatment of IPF. Survival time from diagnosis is two to five years in patients with IPF.
The INSPIRE Trial is a randomized double-blind, placebo controlled Phase III trial. The trial is designed to evaluate the safety and efficacy of interferon gamma-1b in IPF patients with mild-to-moderate impairment in lung function; the primary endpoint of the trial is survival time. The trial will enroll 600 patients at approximately 70 centers in the United States, Europe and Canada. Patients will be randomized at a ratio of 2:1 to receive either 200 micrograms of interferon gamma-1b three times a week or placebo, respectively. Each patient enrolled will be followed for at least 24 months.
"This trial promises to answer many fundamental clinical questions regarding the use of interferon gamma in IPF, most significantly to further investigate the survival findings from the recently completed GIPF-001 study," said study Co-Chair Talmadge E. King, Jr., M.D., Professor and Vice Chairman, Department of Medicine, University of California San Francisco, San Francisco General Hospital. "The study has been designed to target patients with mild-to-moderate disease and we hope that it will lead to a definitive outcome on which to base future patient treatment."
In conjunction with thought leaders from around the world, InterMune designed the INSPIRE Trial based on information learned from its previously completed 330-patient randomized, double-blind, placebo controlled Phase III (GIPF-001) clinical trial and two other independently conducted, randomized, controlled trials. The INSPIRE Trial seeks to confirm observations from these previous studies that suggest interferon gamma may prolong survival in patients with IPF.
"Much of what we learned in the first Phase III trial could not have been predicted based on our previous knowledge of interferon gamma in IPF, but we were encouraged by the potential survival advantage and welcome the opportunity to study patients with milder disease over a longer observation period," said the other Study Co-Chair Ron M. du Bois, M.D., Professor of Respiratory Medicine, Imperial College of Science, Technology and Medicine, and Consultant Physician, The Royal Brompton Hospital, London. "We are pleased that InterMune is supporting the necessary clinical studies to determine the appropriate role of interferon gamma in this life-threatening disease."
"The INSPIRE Trial will be the largest and most comprehensive clinical trial ever conducted in IPF and demonstrates InterMune's ongoing commitment to finding effective treatments for this debilitating disease," said James E. Pennington, M.D., Executive Vice President of Medical and Scientific Affairs at InterMune. "We are pleased that so many of the world's leading centers and investigators have agreed to participate in this trial to further the investigation of treatments for IPF."
For further information concerning the INSPIRE Trial, those interested should visit www.inspiretrial.com.
About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is the most common form of idiopathic interstitial pneumonia. Once symptoms appear, there is a relentless deterioration of pulmonary function and median survival of two to five years after diagnosis. IPF results in scarring, or fibrosis, of the lungs. Equal numbers of men and women get the illness and most cases of IPF are diagnosed when patients are between the ages of 40 and 70.
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. Enlargement (clubbing) of the fingertips may develop. The patient may also become less able to fight infection. In advanced stages of the illness, the patient may need oxygen all the time.
About Actimmune® (interferon gamma-1b)
Interferon gamma is a naturally occurring protein that stimulates the immune system. InterMune markets Actimmune® for the treatment of two life-threatening congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. The most commons side effects are flu-like symptoms, including fever, headache and chills. InterMune is also conducting a Phase III study of interferon gamma-1b in idiopathic pulmonary fibrosis, a Phase III study of interferon gamma-1b in ovarian cancer and a Phase II study of interferon gamma-1b in severe liver fibrosis, or cirrhosis, caused by hepatitis C virus (HCV). Physicians and patients can obtain additional prescribing information regarding Actimmune®, including the product's safety profile, by visiting www.actimmune.com.<<
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