MedImmune Inc. said it has started a Phase I/II trial of itsCytoGam cytomegalovirus immune globulin in patients withHIV.
CMV is found in about half of the U.S. adult population,typically with no medical significance, according toMedImmune. It can cause severe pneumonia, digestive tractulcers and retinitis in immune-compromised patients, such asorgan transplant recipients and AIDS patients. Retinitis due toCMV is the major cause of blindness in AIDS patients.
The trial, which the company expects to complete bySeptember, is designed to determine the safety andpharmacokinetics of CytoGam in AIDS patients.
CytoGam received FDA approval in 1991 for the prevention ofprimary CMV disease in kidney transplant patients. It has beenmarketed in the U.S. by Connaught Laboratories Inc. ofSwiftwater, Pa., since last December.
CytoGam has orphan drug status for the kidney transplantindication, and MedImmune (NASDAQ: MEDI) will probablyapply orphan designation for the AIDS indication, according toFranklin Top, executive vice president and medical director atthe Gaithersburg, Md., company.
The stock closed at $31.75, up 25 cents. -- Steve Usdin
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