Schering-Plough study finds Noxafil better at treating fungal infection than fluconazole

New York, Oct. 25 - Schering-Plough Corp. said Tuesday that a new clinical study demonstrated its investigational antifungal agent Noxafil (posaconazole) oral suspension significantly reduced the incidence of aspergillosis, a serious fungal infection associated with a high rate of mortality, as well as serious invasive fungal infections overall during treatment, in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease compared to treatment with fluconazole.

Noxafil showed decreased deaths due to invasive fungal infections compared to fluconazole. Both drugs were well tolerated, the study found.

The results of the study were presented at the Trends in Medical Mycology meeting in Berlin. Schering-Plough said it was the first randomized, double-blind, controlled long-term study of antifungal prophylaxis (preventive treatment) in patients suffering from severe cases of immunological attack by transplanted cells against the cells or tissue of the host after receiving stem cells from another person.

Invasive fungal infections are a leading cause of death in hematopoietic stem cell transplant recipients, with mortality rates varying between 60% and 90%.

Schering-Plough said Noxafil has demonstrated broad-spectrum activity covering both yeasts (such as Candida) and molds (such as Aspergillus) responsible for serious invasive fungal infections.

"There is an urgent need to prevent serious invasive fungal infections in patients, including infections that are resistant to other therapies or caused by emerging pathogens that can be difficult to diagnose and treat," lead study investigator Andrew J. Ullmann, attending physician for infectious diseases and hematology/oncology at Medical Hospital and Healthcare Center of Johannes Gutenberg University, Mainz, Germany, said in a news release. "The results of this study demonstrate that Noxafil may be an option for long-term preventive treatment, allowing these seriously ill patients to recover."

The study covered 600 patients from 90 centers.

Schering-Plough is a Kenilworth, N.J., health care company.

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