PDL REPORTS RESULTSProtein Design Labs Inc. (PDL) reported Thursday that itshuman anti-cytomegalovirus (CMV) antibody was safe andwell-tolerated in Phase I/II trials on AIDS patients with CMVretinitis.
The Mountain View, Calif., company (NASDAQ:PDLI) presentedthe clinical trial results at the Ninth International AIDSConference in Berlin.
None of the 17 patients enrolled in the trial showed evidence ofan immune response to the antibody, which was administeredin doses ranging from 0.25 to 5.0 milligrams per kilogram ofbody weight.
Patients were treated intravenously every two weeks for up to16 weeks with antibody combined with either ganciclovir orfoscarnet, the FDA-approved drugs for treating CMV retinitis.About 20-25 percent of people with AIDS develop theinfection, which often results in blindness.
The combination therapy delayed disease progression abouttwice as much as either approved drug alone. The median timeto progression to disease for either drug when administeredalone was 60-100 days, based on historical controls (clinicaltrial data on a total of 234 patients published in the NewEngland Journal of Medicine in 1992), explained Laurence Korn,PDL's president and chief executive officer.
But adding the antibody extended that time to 202 days, Kornadded.
Protein Design Labs expects to begin a Phase II/III trial on theMSL-109 antibody, which it acquired from SandozPharmaceuticals Corp. in April, for CMV retinitis in the firsthalf of 1994, Korn told BioWorld. -- JVB
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