Monday December 17, 5:12 pm Eastern Time
Press Release
SOURCE: InterMune, Inc.
InterMune Announces Positive Phase II Results of Actimmune(R) For the Treatment of Cryptococcal Meningitis
Data Show Significant Advance in the Treatment of Life-Threatening Fungal Infection
CHICAGO and BRISBANE, Calif., Dec. 17 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN - news) today announced positive results from its Phase II clinical trial investigating Actimmune (Interferon gamma-1b) as adjunctive therapy to conventional anti-fungal treatment of cryptococcal meningitis, a life-threatening fungal infection of the central nervous system. The current standard of care is treatment with amphotericin B (AmB) followed by fluconazole. The addition of Actimmune to the standard regimen showed a strong trend toward more rapid clearance of cryptococcus fungus from cerebral spinal fluid (CSF), when compared with conventional anti-fungal therapy alone. These data will be presented tomorrow at the 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago.
In the study, 70 patients with acute cryptococcal meningitis were randomized to receive 100 mcg of Actimmune, 200 mcg of Actimmune or placebo three times per week for ten weeks in addition to conventional anti-fungal therapy. After two weeks, fungal cultures in the CSF were negative in 38% of patients who received Actimmune as adjunctive therapy as compared to 18% of placebo recipients. Adverse events were similar in all three treatment groups.
``This is the first randomized controlled study of adjunctive Actimmune treatment for an invasive fungal infection,'' said James Pennington, MD, Executive Vice President of Medical and Scientific Affairs for InterMune. ``These data indicate that Actimmune has the potential to improve clinical outcomes when added to conventional anti-fungal therapy. We plan to accelerate the development of Actimmune through a Phase III program in cryptococcal meningitis and additional Phase II trials in other types of systemic fungal infections, such as aspergillosis.''
``These Phase II Actimmune data, along with the Phase III trial results of oritavancin in Gram-positive infections also being presented at ICAAC today, demonstrate InterMune's strong infectious disease program,'' said W. Scott Harkonen, MD, President and CEO of InterMune. ``Our goal is to develop Actimmune for a broad range of fungal infections, representing a potential market opportunity of up to $500 million.''
The strong trends observed in the clinical trial further validated the results achieved in a study published in the September 2000 Journal of Antimicrobial Chemotherapy, which showed that, in a mouse model of cryptococcal infection, combination therapy using Actimmune and AmB cured 78% of mice infected with cryptococcal fungus, while AmB alone cured only 10%.
``These results are exciting because they support the hypothesis that the immunomodulatory properties of interferon gamma can supplement the treatment of current anti-fungal treatment,'' said Peter Pappas, M.D., Professor of Medicine at the University of Alabama, Birmingham, and principal investigator for the study. ``The potential ability of adjunctive therapy with Actimmune to accelerate CSF clearance may reduce treatment duration and hospitalization in patients with cryptococcus and other invasive fungal infections.''
Cryptococcal meningitis is associated with a compromised immune system, often caused by HIV infection, cancer, chemotherapy and organ transplantation. In such immunocompromised hosts, infection by the fungus frequently leads to invasion of the central nervous system, resulting in meningitis, increased intracranial pressure, and permanent neurologic damage.
About InterMune
InterMune is a commercial-stage biotechnology company dedicated to developing innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune has three marketed products, growing product revenues and advanced-stage clinical programs addressing a range of diseases with attractive commercial markets. For additional information about InterMune, please visit intermune.com . |
