BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Thursday, 7 November 1996.
The data, presented today at the 16th Chemotherapy Foundation Symposium in New York City, included 14 patients whose disease was resistant to conventional chemotherapy or who had relapsed after prior therapy. DaunoXome is NeXstar Pharmaceuticals' proprietary liposomal formulation of the anthracycline chemotherapy agent daunorubicin.
Patients included in this study received 100 mg/m2 of DaunoXome every three weeks. Of the 14 patients treated, 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. The data were presented by Anil Tulpule, M.D., assistant professor of clinical medicine in the Division of Hematology at the University of Southern California School of Medicine. Dr. Tulpule is co-principle investigator of this study, which is being conducted at six sites nationwide.
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. Three of these patients had received prior anthracycline chemotherapy. An additional three patients (21 percent) achieved stable disease status, defined as stable tumor mass or an 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.
Dr. Tulpule also stated that, "there were no grade 3 or grade 4 non-hematological toxicities, and though there were some instances of grade 3 or grade 4 neutropenia, none were long-lasting." Dr. Tulpule also stated that, "to date, the disease has not progressed in any of the patients showing response or stable disease have started progressing."
Other sites participating in this ongoing study include Northwest Kaiser Permanente in Portland, Ore.: North Shore University Hospital in Manhasset, N.Y.; Scripps Memorial Hospital in La Jolla, Calif.; Northwestern University Medical School in Chicago; and the Denver Medical Health Center.
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, glioma and HIV-associated lymphoma.
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, Colorado; research, development and manufacturing facilities in San Dimas, California; Antwerp, Belgium; Lakewood, Colorado, and Boulder; and marketing subsidiaries worldwide.
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CONTACT: NeXstar Pharmaceuticals Joseph Alper, Director, Corporate Communications, (303) 546-7717 or Katy Doherty, Manager, Media Relations, (303) 546-7889 or http://www.nexstar.com
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