BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Friday, 6 December 1996.
DaunoXome, the Company's liposomal formulation of the anticancer agent daunorubicin, has been approved in the U.S. and 14 other countries as a first-line therapy for the treatment of advanced HIV-associated Kaposi's sarcoma. AmBisome, the Company's liposomal formulation of the antifungal agent amphotericin B, has been approved in 24 countries as a therapy for life-threatening fungal infections. The U.S. Food and Drug Administration is now reviewing a New Drug Application (NDA) for AmBisome.
In the first presentation, Marc Boogaerts, M.D., of the University of Leuven, Belgium, will present data showing that AmBisome, when used to treat fungal infections in children, is "slightly more cost-effective than starting with amphotericin B, despite the fact that AmBisome itself is more expensive than generic amphotericin B."
In adults, AmBisome therapy was only 13 percent more expensive than was amphotericin B therapy. According to Dr. Boogaerts, cost savings on AmBisome therapy came from shorter hospital stays for patients treated with AmBisome, compared to conventional amphotericin B, and from reduced cost of ancillary treatment related to side effects caused by conventional amphotericin B therapy.
To conduct this analysis, Dr. Boogaerts and his colleagues used data from two European phase III studies comparing the efficacy and safety of AmBisome and conventional amphotericin B therapy in the treatment of febrile neutropenia (FUO) in adults in children. These studies had three treatment arms in which patients received conventional amphotericin B therapy at the standard 1 mg/kg dose or AmBisome at either 1 milligram per kilogram (mg/kg) of body weight or 3 mg/kg. The data from these studies were included in the AmBisome NDA.
According to Dr. Boogaerts, "An intention-to-treat analysis of first-line treatment demonstrated that, in adults, efficacy rates are 46 percent, 49 percent and 64 percent for amphotericin B, AmBisome 1 mg/kg, and AmBisome 3 mg/kg respectively. In children, efficacy rates are 51 percent, 64 percent and 63 percent for amphotericin B, AmBisome 1 mg/kg, and AmBisome 3 mg/kg respectively. The incidence of severe drug-related adverse events in all patients receiving AmBisome was 1 percent."
In the second presentation of the weekend, Anil Tulpule, M.D., of the University of Southern California School of Medicine, presented data from a phase II study in which DaunoXome was evaluated as a treatment for low-grade and intermediate-grade non-Hodgkin's lymphoma.
Of the 14 patients treated with 100 mg/m2 of DaunoXome every three weeks, 11 (79 percent) had stage 4 disease with bone marrow involvement. Eight patients (57 percent) had failed two or more prior chemotherapy regimens, and the remaining six had failed one prior regimen. Five patients had received an average of 350 mg/m2 of anthracycline in prior treatments.
Dr. Tulpule stated that following treatment with DaunoXome, six patients (43 percent) had a partial response, defined as a greater than 50 percent reduction of tumor mass lasting at least four weeks. Three of these patients had received prior anthracycline chemotherapy. On average, partial responses were seen after three cycles of therapy, and the average duration of response is nine weeks and increasing, with all patients still responding.
An additional three patients (21 percent) achieved stable disease status, defined as stable tumor mass or a slight increase in existing disease without appearance of any new lesions. Of these patients, one had received previous anthracycline therapy. Two of the five patients who did not respond died of their disease before receiving a second cycle of therapy, but were included in the intention-to-treat analysis.
DaunoXome is currently approved as a primary therapy for advanced HIV-associated Kaposi's sarcoma in the U.S., Canada, and 13 European countries. NeXstar Pharmaceuticals is currently conducting clinical trials in non-Hodgkin's lymphoma and various other forms of cancer, including breast cancer, leukemia and glioma.
NeXstar Pharmaceuticals, Inc., is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and marketing of products to treat life-threatening diseases, including cancer and infectious diseases. The Company currently markets two drugs, AmBisome and DaunoXome. The Company has headquarters in Boulder, Colo.; research, development and manufacturing facilities in San Dimas, Calif.; Antwerp, Belgium; Lakewood, Colo., and Boulder; and marketing subsidiaries worldwide.
Note for editors: This press release is available on our Web site at http://www.nexstar.com/Press_Releases/PR96.htm. After viewing the press release at this site you can save it as a text file for further use.
CONTACT: NeXstar Pharmaceuticals Inc., Boulder Joseph Alper, 303/546-7717 Katy Doherty, 303/546-7889 web site at http://www.nexstar.com
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