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A new liposomal antifungal agent is as effective and safer than conventional therapy for the treatment of presumed fungal infections in immunocompromised patients, according to data presented here today at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
In the double-blind trial, 687 adult and pediatric patients with neutropenia (a depressed level of infection-fighting white blood cells) and persistent fever that did not resolve with antibiotic treatment were randomized to receive either conventional amphotericin B or AmBisome. Therapeutic success -- measured by a combination of factors including, among others, resolution of fever, absence of emergent fungal infection, and patient survival for at least seven days after therapy -- was equivalent between the two groups.
In August, the U.S. Food and Drug Administration (FDA) granted clearance to market AmBisome for use as empirical therapy for presumed fungal infections in patients with depressed immune function and fever of unknown origin. AmBisome also received marketing clearance from the FDA for the treatment of patients with confirmed infections caused by various fungal species (Aspergillus, Candida and Cryptococcus) who are refractory to or intolerant of conventional amphotericin B therapy. In addition, AmBisome is indicated for the treatment of visceral leishmaniasis (a parasitic infection).
Results of the study show that overall AmBisome(R), the first true liposomal formulation of amphotericin B, was associated with a therapeutic success rate equivalent to conventional amphotericin B, but was significantly more effective in the prevention of proven breakthrough fungal infections (11 or 3.2% vs 27 or 7.8%). Effectiveness in prevention of both proven and presumed emergent fungal infections was equivalent between the two groups. In addition, among patients treated with AmBisome compared with patients treated with conventional amphotericin B, there was a significant reduction in the incidence of infusion-related fever (17% vs 44%), chills/rigors (18% vs 54%), cardiorespiratory events (19.5% vs 51.1%), and the development of nephrotoxicity (19% vs 34%). Patients treated with amphotericin B had a lower incidence of diarrhea (27% for amphotericin B vs 30% for AmBisome) and nausea (39% vs 40%). Anaphylaxis has been reported with products containing amphotericin B, including AmBisome. Overall there was a lower incidence of adverse events associated with the use of AmBisome as compared to amphotericin B. As anticipated, the liposomal AmBisome was less likely than conventional amphotericin B to cause kidney damage.
"The improved safety in AmBisome is a welcome therapeutic advance in the empirical treatment of systemic fungal infections," said John M. Hiemenz, M.D. of the Walt Disney Memorial Cancer Institute in Orlando, Florida, and one of the study investigators. "This study showed clearly that AmBisome is as effective but safer than amphotericin B." The study was conducted by the Mycoses Study Group and the Empirical Antifungal Study Group.
Patients at risk for systemic fungal infections include those with compromised immune systems, such as patients receiving cancer treatment, HIV-infected individuals, and bone marrow transplant patients. Patients afflicted with systemic fungal infections typically exhibit low levels of infection-fighting white blood cells and fever that does not resolve with antibiotic treatment.
Amphotericin B, introduced in the 1960s, is an antifungal agent which has long been considered the standard of care. AmBisome is the first and only amphotericin B product to be indicated for empirical therapy for presumed fungal infections in febrile, neutropenic patients.
Fujisawa licenses the AmBisome marketing and distribution rights in the United States and Canada from NeXstar Pharmaceuticals, Inc. NeXstar will co-promote AmBisome in the United States and will also be responsible for manufacturing the product. AmBisome is currently approved and marketed by NeXstar in 29 other countries.
Fujisawa USA, Inc., headquartered in Deerfield, Ill., is a manufacturer of proprietary and multi-source pharmaceutical products and a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical, founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its operations not only in Japan but on a global scale, particularly in North America, Europe and Asia. Additional information on Fujisawa USA, Inc. can be found at www.fujisawausa.com.
NeXstar Pharmaceuticals, Inc. is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and globalization of products to treat life-threatening diseases, including cancer and infectious diseases. Based in Boulder, Colo., NeXstar Pharmaceuticals' additional research, development and manufacturing facilities are located in San Dimas, Calif., and Lakewood, Colo.; marketing subsidiaries are located worldwide. (http://www.nexstar.com/press_releases/pr97.htm).
Contact: NeXstar Pharmaceuticals Michael E. Hart, 303/546-7613 Katy Doherty, 303/546-7889 or Fujisawa USA, Inc. Mark J. Wanda, 847/317-1256
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