Schering-Plough Reports Noxafil Meets Primary Endpoint in Clinical Study in Invasive Fungal Infections

KENILWORTH, N.J. -- Schering-Plough Corporation today reported that a Phase III clinical study evaluating Noxafil (posaconazole suspension) in patients with invasive fungal infections successfully met the study's primary endpoint. Posaconazole is a novel, oral broad-spectrum antifungal being developed for the treatment of life-threatening invasive fungal infections, including Aspergillosis, that are resistant to currently available antifungal treatments. These opportunistic fungal infections occur in severely immunocompromised patients, such as organ transplant patients or cancer patients undergoing chemotherapy.

The primary endpoint of the study was a clinical and mycological response from the fungal infection. Based on the results of this study, the company expects to submit new drug applications for Noxafil to the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) seeking marketing approval.

"We are very pleased with the positive results of Noxafil and the implications of this study for potentially advancing the treatment of patients with invasive fungal infections that are refractory or intolerant to currently available treatments," said Cecil B. Pickett, PhD, president of Schering- Plough Research Institute. "At the same time, we are very proud of the work of our dedicated research team and the excellent science behind the development of this potential new therapy," Pickett said.

"There is an unmet medical need worldwide for new treatments for severe invasive fungal infections, especially given the increased incidence of fungal resistance to currently available therapies," said Dr. Issam Raad, chairman, antibiotic task force, and chairman (ad interim), infectious diseases, infection control and employee health department at the M.D. Anderson Cancer Center in Houston, and one of the principal investigators of the study. "The results of this study demonstrate that Noxafil achieved a significant treatment effect in patients with these fungal infections."

The Noxafil study enrolled 337 patients with proven or probable invasive fungal infections documented to be resistant or clinically refractory to standard antifungal therapies, or who were precluded from receiving other antifungal therapies because of potential toxicities or contraindications. The company said that no further details of the clinical study will be available until all data analyses are complete and results are presented in a public, scientific forum.

Source: Schering-Plough Corporation