BUSINESS WIRE; Wednesday, December 10, 1997
AmBisome is cleared for use in the United States as empirical therapy in the treatment of presumed systemic (blood borne) fungal infections in patients with weakened immunity because of lowered white blood cell counts, such as patients receiving cancer-fighting therapies, or those with HIV-infection.
Several abstracts on AmBisome were presented and others were displayed as posters during the annual meeting for the American Society of Hematology (ASH), December 5-9, in San Diego. One study showed the benefits of AmBisome treatment in patients who had received a bone marrow transplant (BMT) including a subset of patients who had received an allogeneic BMT (a type of transplant where the bone marrow of a related donor is used). Such a class of patients is at higher risk for fungal infections as well as nephrotoxicity (kidney toxicity or damage to kidney cells) because their immune systems have been suppressed due to the concurrent use of immunosuppressant drugs.
The AmBisome abstract, titled "Improved Safety and Efficacy of AmBisome (liposomal amphotericin B) compared with amphotericin B in the Empirical Treatment of Febrile Neutropenic Patients Undergoing Bone Marrow Transplantation," by Pablo J. Cagnoni, assistant professor, Cancer Center of the University of Colorado Health Sciences Center, provided new analysis in a subset of patients from the pivotal, phase III study on AmBisome, conducted by Fujisawa USA, with lead investigator Thomas Walsh, M.D., of the National Cancer Institute, Section of Infectious Diseases.
This report focused on a subset of patients from the pivotal, phase III, double-blind, randomized study of AmBisome vs. amphotericin B, conducted with 687 patients. The subset consisted of 315 BMT patients who received at least one dose of AmBisome (154 patients) or amphotericin B (161 patients). Of the 315 patients, 103 received an allogeneic BMT. Of the 103 patients, 53 received AmBisome and 50 received traditional amphotericin B. Results showed that the number of emergent fungal infections (new proven infections developed while on study drug) in the overall group of 315 patients was lower in the AmBisome group (1.9 percent) vs. the amphotericin B group (5.6 percent). The difference in the allogeneic patient group was as follows: the AmBisome group reported 1.9 percent, and the amphotericin B group reported 14 percent. Results showed that the number of presumed fungal infections in the overall group of 315 patients was slightly higher in the AmBisome group (3.9 percent) vs. the amphotericin B group (3.7 percent). The difference in the allogeneic patient group was as follows: the AmBisome group reported 5.7 percent and the amphotericin B group reported 2 percent. The authors reported their conclusion that AmBisome appeared to be more effective in preventing emergent fungal infections in the overall group of 315 patients.
AmBisome was associated with less nephrotoxicity than amphotericin B (35 percent). However, nephrotoxicity was still reported in 20 percent of the patients that received at least one dose of AmBisome. In the allogeneic BMT group of patients, nephrotoxicity was reported in 32 percent of the AmBisome patients and 66 percent of the amphotericin B patients. Patients treated with AmBisome had a lower incidence of chills (8 percent for AmBisome vs. 39 percent for amphotericin B), fever (5 percent vs. 21 percent), dyspnea (shortage of breath) (6 percent vs. 11 percent) and hyperbilirubinemia (an excessive amount of the pigment bilirubin in the blood) (7 percent vs. 10 percent). Patients treated with amphotericin B had a lower incidence of diarrhea (4 percent for amphotericin B vs. 7 percent for AmBisome) and respiratory failure (4 percent vs. 6 percent).
NeXstar Pharmaceuticals Inc. is a commercial pharmaceutical company engaged in the discovery, development, manufacturing and marketing of products to treat serious and life-threatening illnesses. The company currently markets two drugs in the United States and around the world, AmBisome and DaunoXome. Based in Boulder, Colo., NeXstar Pharmaceuticals maintains additional research, development and manufacturing facilities in San Dimas, Calif., and marketing subsidiaries worldwide.
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.
Note to Media: This release can be obtained from our Internet homepage at http://www.nexstar.com/Press_Releases/PR97.htm .
CONTACT: NeXstar Pharmaceuticals Inc. Michael Hart, 303/546-7613 Katy Doherty, 303/546-7889 or Fujisawa USA Inc. Mark Wanda, 847/317-1256
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