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Contacts at NeXstar Pharmaceuticals:
Director, Corporate Communications
Manager, Media Relations
NEW ORLEANS, SEPTEMBER 17, 1996 - Independent European investigators today will present data from two multi-center, phase III comparative clinical trials conducted with AmBisome, NeXstar Pharmaceuticals' liposomal formulation of amphotericin B. The presentations will be made this afternoon in New Orleans during the session "Progress in Antifungal Therapy and Prevention" at the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
NeXstar Pharmaceuticals and its U.S. development and marketing partner Fujisawa USA have decided to include the data from these studies in its U.S. New Drug Application for AmBisome. The two companies expect to complete the NDA filing within the next several weeks.
In the first presentation, A.C.A.P. Leenders, M.D., of the University Hospital Rotterdam, in The Netherlands, will describe the results of a study in which AmBisome was compared to amphotericin B as a treatment for cryptococcal meningitis in HIV- infected patients. Cryptococcal meningitis is a potentially life- threatening infection of the lining that surrounds the brain and of the cerebral spinal fluid (CSF).
In the paper to be presented, the investigators conclude that "[AmBisome] will sterilize the CSF significantly earlier than 0.7 mg/kg [of amphotericin B], that it has at least equal clinical efficacy and a significantly lower rate of nephrotoxicity when used for the treatment of cryptococcal meningitis in HIV infected patients." The mean time to sterilization of the CSF was 14 days for AmBisome, compared to more than 21 days for amphotericin B.
In the second presentation, Michael Ellis, M.D., a member of the European Organisation for the Research and Treatment of Cancer (EORTC), will detail the results of a randomized, multi-center study of low- and high-dose AmBisome therapy in the treatment of invasive aspergillosis. In this study of 119 cancer patients with impaired immune systems, the investigators found that treatment with low-dose AmBisome for a median of 20 days produced a response of 68 percent. In a separate talk at the same session on antifungal therapy, a team of U.S. investigators will present data from a multi-center study showing that the response rate for conventional amphotericin B therapy of invasive aspergillosis was 24 percent.
NeXstar Pharmaceuticals, Inc. is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and marketing of products to treat life-threatening diseases. The Company currently markets two drugs, AmBisome and DaunoXome. The Company has headquarters in Boulder, Colorado; research, development and manufacturing facilities in San Dimas, California; Antwerp, Belgium; Lakewood, Colorado, and Boulder; and marketing subsidiaries worldwide.
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