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Abelcet More Effective Than AmBisome In Leukemia Patients With Fungal Infections SAN DIEGO, CA -- March 19, 1999 -- Comparative head-to-head data on The Liposome Company, Inc.’s Abelcet(R) (Amphotericin B Lipid Complex Injection) versus a competitive liposomal amphotericin B product, NeXstar Pharmaceutical Inc.’s AmBisome(R) (liposomal amphotericin B) found Abelcet to be statistically more effective than AmBisome for use in patients with leukemia who had diagnosed or suspected fungal infection. The study, which was presented at the ninth annual Focus on Fungal Infections meeting, also documented a lower incidence of hepatic toxicity for Abelcet. The study was conducted by The University of Texas, M.D. Anderson Cancer Center in Houston. The prospective, open-label, randomised study compared the two lipid based formulations of amphotericin B in the treatment of leukemia patients with either suspected or confirmed fungal infections. The 75 patients developed 82 febrile episodes that were unresponsive to antibacterial therapy and were prospectively randomised to receive either Abelcet or AmBisome. Both drugs were dosed as follows: 3 mg/kg/day for fever of unknown origin (FUO), 4-5 mg/kg/day for pneumonia of unknown pathogen (PUP), and 5 mg/kg/day for definite fungal infections (DFI). On an intent-to-treat basis, the overall response to therapy was 27/43 (63 percent) for Abelcet and 15/39 (39 percent) for AmBisome. Response rates for subcategories of infection were FUO (100 percent versus 75 percent), PUP (80 percent versus 56 percent), DFI (30 percent versus 29 percent), Abelcet versus AmBisome, respectively. The response to therapy was higher for Abelcet despite the fact that AmBisome-treated patients received higher median daily doses (4 mg/kg/day for AmBisome versus 3 mg/kg/day for Abelcet) and were treated with longer courses of therapy (15 day median course for AmBisome versus a 10 day median course for Abelcet). Patients randomised to receive Abelcet were more likely to be neutropenic at baseline (93 percent versus 79 percent) and therefore at greater risk of having a poor outcome. Although AmBisome-treated patients had a lower incidence of acute infusion-related toxicities (70 percent versus 36 percent), severe infusion-related toxicities requiring discontinuation of therapy occurred in only three patients (one Abelcet and two AmBisome). The overall median increase in serum creatinine was 37.5 percent for Abelcet and 24.3 percent for AmBisome. A persistent increase in serum bilirubin of greater than 1.5 times baseline was 38 percent for Abelcet-treated patients versus 59 percent for AmBisome-treated patients. Abelcet is marketed in the United States for the treatment of severe, systemic fungal infections in patients who are refractory to or intolerant of conventional therapy. In general, the adverse events most commonly reported with Abelcet are transient chills and/or fever during infusion of the drug. Abelcet is contraindicated in patients who have shown hypersensitivity to amphotericin B or any other component in the formulation. Related Links: Abelcet, The Liposome Company, Inc., AmBisome E-mail this page to a friend or colleague! To print, use this version