MEDIMMUNE BEGINS STUDY OF CYTOGAM IN AIDS PATIENTS
MEDIMMUNE BEGINS STUDY OF CYTOGAM IN AIDS PATIENTS GAITHERSBURG, Md., March 31 /PRNewswire/ -- MedImmune, Inc.
(NASDAQ: MEDI) announced today the start of a combined Phase I/II study of CytoGam (TM), the company's cytomegalovirus (CMV) immune globulin, in patients with HIV infection. Retinitis due to CMV is the major cause of blindness in AIDS patients.
The study, expected to be completed by September 1992, is designed to determine the safety and pharmacokinetics of CytoGam in AIDS patients. The study is intended to provide information on the level and duration of CMV antibodies achieved by CytoGam infusion. These results will be used to select a dosing schedule for CytoGam efficacy trials expected to begin in fall, 1992. CytoGam has been approved by the U.S. Food and Drug Administration for the prevention of primary CMV disease in kidney transplant patients. A multicenter clinical trial using CytoGam to prevent CMV in liver transplant patients was also recently completed and results will be submitted to the FDA to expand label claims. CMV is found in approximately half of the adult population in the United States, typically with no medical significance. In patients that are immune compromised, however, such as organ transplant recipients or AIDS patients, CMV can cause severe pneumonia, digestive tract ulcers and retinitis. In about 30 percent of AIDS patients CMV is recognized as a major contributor to death. MedImmune, Inc. was founded in 1988 to develop, manufacture and market therapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The company's corporate headquarters is in Gaithersburg. -0- 3/31/92 /CONTACT: Franklin H. Top, Jr. M.D., executive vice president and medical director of MedImmune, Inc. 301-417-0770; or Fredric Spar of Kekst and Company, 212-593-2655, for MedImmune/ (MEDI) CO: MedImmune, Inc. ST: Maryland IN: MTC SU:
AH -- NY070 -- 3448 03/31/92 13:20 EST
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|Date:||Mar 31, 1992|
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