A Phase I/II clinical trial of Protein Design Labs (PDL) Inc.'shuman antibody for the treatment of chronic active hepatitis Binfection has yielded positive results, according to thecompany.
The study evaluated the safety and preliminary antiviraleffects of PDL's (NASDAQ:PDLI) Human Anti-Hepatitis BAntibody in 12 patients. Participants were treated at theUniversity of Texas Medical Branch at Galveston and theUniversity of Miami Medical School with one of three doselevels (0.5, 1.0 or 2.0 mg/kg of body weight). They were givenseven to nine doses of antibody during a 35-37 day period.
Investigator David Paar of the University of Texas MedicalBranch reported that levels of key markers for hepatitis Bdisease declined 50 percent or more in most patients in thestudy who had elevated levels before treatment. This includeddecreases in enzymes that are released into the blood byinfected liver cells (in five of 10 patients), in hepatitis B surfaceantigen (in 10 of 12 patients) and in hepatitis B DNA (in five ofnine patients).
PDL of Mountain View, Calif., next plans to conduct Phase IItrials to study the effect of longer courses (several months) ofthe treatment.
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