AmBisome compassionate use protocol initiated.BOULDER, Colo.--(BUSINESS WIRE)--March 5, 1996--NeXstar Pharmaceuticals, Inc., (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :NXTR) announced today that a compassionate use protocol for AmBisome, the company's liposomal formulation of the antifungal agent amphotericin B, has begun enrolling patients. Previously, the U.S. Food and Drug Administration had accepted the Company's protocol design and agreed that the Company could initiate a protocol for the compassionate use of AmBisome (liposomal amphotericin B) for the treatment of invasive fungal infections. The protocol, designed by NeXstar Pharmaceuticals and development partner Fujisawa USA, is open to patients of any age who have failed, cannot tolerate or have a high risk for toxicity from amphotericin B. There will be no limit on the number of centers or number of patients eligible to participate in this open-label program. Patient enrollment is being coordinated by BioPharm, a contract research organization administering the protocol. Those eligible for the protocol include patients immunosuppressed from bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. , active chemotherapy for cancer, or the administration of other immunosuppressive agents; patients with AIDS, premature and newborn infants; or patients otherwise compromised, including those with diabetes, who may be susceptible to opportunistic fungal infections. Patients with a wide range of fungal infections, including candidiasis candidiasis (kăn'dĭdī`əsĭs), infection of the mucous membranes caused by the fungus Candida albicans. Other terms for candidiasis are yeast infection, moniliasis (after a former name of the fungal genus), and thrush, the , aspergillosis Aspergillosis Definition Aspergillosis refers to several forms of disease caused by a fungus in the genus Aspergillus. Aspergillosis fungal infections can occur in the ear canal, eyes, nose, sinus cavities, and lungs. , cryptococcosis cryptococcosis: see fungal infection. , and histoplasmosis histoplasmosis: see fungal infection. , are eligible for treatment. Physicians interested in obtaining AmBisome can call BioPharm at 1-800-787-8268. 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 in Europe, AmBisome and DaunoXome. The Company has headquarters in Boulder, Colorado; research, development and manufacturing facilities in San Dimas, California San Dimas is a city located in Los Angeles County, California. As of the 2004 census, the city had a total population of 36,200. History Don Palomares received a 15,000 acre (61 km) ; Antwerp, Belgium; Lakewood, Colorado, and Boulder; and marketing subsidiaries worldwide. CONTACT: NeXstar Pharmaceuticals, Inc., Boulder Joseph Alper, 303/546-7717 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion