InterMune, Inc., a biopharmaceutical company, announced the publication, in The New England Journal of Medicine, of previously presented results of the company's initial randomized, double-blind, placebo-controlled Phase III trial (GIPF-001) evaluating the efficacy and safety of Actimmune (interferon gamma-1b) for the treatment of patients with idiopathic pulmonary fibrosis (IPF), a debilitating and deadly lung disease.
The findings from the GIPF-001 trial form the basis for the company's recently initiated, 600 patient, INSPIRE Trial, a randomized, double-blind, placebo-controlled pivotal phase III trial. The first patient was enrolled in this trial in December 2003.
"The data from the GIPF-001 study are sufficient to warrant further investigation in a larger and longer clinical trial," said Talmadge King, Jr., MD, senior author of the New England Journal of Medicine publication, INSPIRE study co-chair, professor and vice chairman, Department of Medicine, University of California San Francisco, San Francisco General Hospital. "The ongoing INSPIRE Trial is designed to treat patients with mild-to-moderate disease. We are hopeful that this trial will lead to a definitive outcome on which to base future patient treatment."
The INSPIRE Trial will be the largest and most comprehensive clinical trial conducted to date in patients with IPF. 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 clinical trial (GIPF-001) and two other independently conducted, randomized, controlled trials.
This randomized double-blind, placebo-controlled Phase III trial was 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 centres 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 subcutaneously, three times per week or placebo, respectively. Each patient enrolled will be followed for at least 24 months.
Idiopathic pulmonary fibrosis (IPF) is the most common form of idiopathic interstitial pneumonia affecting approximately 83,000 people in the US alone. 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. 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 between the ages of 40 and 70. There are currently no drugs approved by the US Food and Drug Administration for the treatment of IPF. Median survival time from diagnosis is two to three years in patients with IPF.