InterMune Initiates Phase II Trial Evaluating Actimmune in the Treatment of Cryptococcal Meningitis

InterMune Initiates Phase II Trial Evaluating Actimmune in the Treatment of Cryptococcal Meningitis

Business Wire - February 2, 2000

PALO ALTO, Calif.--(BW HealthWire)--Feb. 2, 2000--InterMune Pharmaceuticals today announced that it has initiated a Phase II clinical trial evaluating the safety, efficacy and dosing of Actimmune(R) (interferon gamma-1b) in the treatment of cryptococcal meningitis, a life-threatening fungal infection. The study will be conducted at seven medical centers in the U.S. and two centers in Peru, and is expected to enroll 60 patients. Actimmune was approved by the U.S. Food and Drug Administration in 1991 for the reduction in frequency and severity of serious infections associated with chronic granulomatous disease.

"We are excited about the initiation of this clinical trial as it represents a significant step in the development and commercialization of Actimmune(R) for the treatment of serious fungal infections," said W. Scott Harkonen, M.D., President and CEO of InterMune.

Cryptococcal meningitis is a lethal fungal disease affecting the lining of the brain. The incidence of fungal infections including cryptococcal meningitis has increased dramatically over the past decade especially among patients with a compromised immune system such as those infected with the HIV virus. Intravenous amphotericin followed by fluconazole by mouth is now the standard of care, however, immunocompromised patients respond poorly to this regimen. It is believed that the addition of Actimmune(R) may improve the clinical outcome, especially in the first 2 weeks when the mortality rate is the highest.

The combination of interferon gamma with amphotericin has been shown to be more than 35 times more potent at reducing the amount of fungus in an animal model of the disease. A preclinical study in mice with cryptococcal meningitis compared Actimmune in combination with amphotericin to amphotericin alone. Study results showed that more than 95% of mice treated with the combination therapy had no detectable fungus in the brain compared to 20% of mice on amphotericin alone.

The Phase II clinical trial is a multi-center, international, placebo-controlled, dose comparison study evaluating the safety, efficacy, and optimum dose of Actimmune(R) in 60 patients with acute cryptococcal meningitis receiving standard antifungal medications. Patients in the trial may be either HIV positive or HIV negative. Treatment with Actimmune(R) will last 10 weeks and patients will be followed for an additional four weeks. The primary endpoint will be clearance of the infection.

InterMune is also developing Actimmune(R) for other fungal diseases, idiopathic pulmonary fibrosis, multi-drug resistant pulmonary tuberculosis, atypical mycobacteria and cystic fibrosis.

InterMune Pharmaceuticals, Inc. develops and commercializes innovative products for the treatment of serious infectious and pulmonary diseases. The Company currently markets Actimmune(R) (Interferon gamma-1b injection) in the U.S. for the treatment of chromic granulomatous disease (CGD). Earlier this year, InterMune filed a Biologics License Application (BLA) with the FDA for a second congenital disorder, osteopetrosis.

CONTACT: InterMune Pharmaceuticals W. Scott Harkonen, M.D. President and CEO (650) 843-2855 or Burns McClellan Lisa Fern (media) (212) 213-0006
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