Noxafil Prevents Invasive Fungal Diseases

January 24, 2007

MAINZ, Germany -- A novel antifungal agent has emerged from two randomized trials as effective and safe in preventing invasive fungal disease after chemotherapy or treatment for graft-versus-host disease.

MAINZ, Germany, Jan. 24 -- A novel antifungal agent has emerged from two German randomized trials as effective and safe in preventing invasive fungal disease after chemotherapy or treatment for graft-versus-host disease (GvHD).

In patients under treatment for GvHD after an allogeneic stem-cell transplant, Noxafil (posaconazole) did as well or better at preventing invasive fungal disease than Diflucan (fluconazole), reported Andrew Ullmann, M.D., of the Johannes Gutenberg University here, and colleagues in the Jan. 25 issue of the New England Journal of Medicine.

In the other study, also reported in the Jan. 25 NEJM, Noxafil out-performed both Diflucan and Sporanox (itraconazole) in patients with neutropenia after chemotherapy, according to Oliver Cornely, M.D., of the University of Cologne.

The antifungal was approved by the FDA last September.

Dr. Ullmann and colleagues conducted a randomized double-blind trial of Noxafil and Diflucan as prophylaxis against invasive fungal disease in 600 hematopoietic stem-cell transplant recipients who were also receiving immunosuppressive therapy for GvHD.

Noxafil and Diflucan were equally good at preventing invasive fungal disease overall - the occurrence rate was 5.3% and 9.0%, respectively - but the rate of proven or probable invasive aspergillosis was 2.3% among Noxafil patients, compared with 7.0% among those on Diflucan. The difference was statistically significant at P=0.006.

Overall mortality was similar, Dr. Ullmann and colleagues reported, but the number of deaths from invasive fungal infections was 1% in the Noxafil group compared with 4% in the Diflucan -- a difference that was significant at P=0.046.

Dr. Cornely and colleagues conducted a randomized trial, in which evaluators were unaware of treatment assignment, of Noxafil, Diflucan and Sporanox as prophylaxis among 602 patients with prolonged neutropenia.

The patients got the study drugs with each cycle of chemotherapy until they recovered from neutropenia and had a complete remission, until they had an invasive fungal infection, or for 12 weeks, whichever came first.

The researchers found the rate of proven and probable invasive fungal diseases was 2% among Noxafil patients, compared with 8% for both of the other medications. Also, the rate of invasive aspergillosis with Noxafil was 1%, compared with 7% for the other two, the researchers reported.

Both differences were statistically significant at P

Dr. Cornely and several of his co-authors reported grant support and other financial links to several pharmaceutical companies, including Schering-Plough. Some members of the research team own stock options in Schering-Plough and others are employed by the Schering-Plough Research Institute.

Dr. Ullmann and several of his co-authors reported grant support and other financial links to several pharmaceutical companies, including Schering-Plough. Three members of the research group hold stock options in Schering-Plough.

Both Dr. De Pauw and Dr. Donnelly reported receiving consulting or lecture fees from several pharmaceutical companies, including Schering-Plough.