In collaboration with Protein Design Labs, Inc., the CRPRC conducted two studies this past year to further their research in the area of developing antibodies for clinical use in humans. The antibody tested in the first study is currently being evaluated in clinical trials for CMV retinitis treatments in human AIDS patients. Eighteen rhesus macaques were used to compare pharmacokinetics of three formulations of the antibody. Pharmacokinetic testing of the formulations on rhesus was necessary to assure product equivalency, allowing the human clinical trials to continue uninterrupted. The second study characterized the pharmacokinetics of several different antibodies directed at E- and P-Selectin, with the goal of developing a potential therapeutic for many human inflammatory conditions. Twenty-five rhesus were used to determine the serum half-life of the antibodies, as well as the best dosing regime to use in planned efficacy studies with these same antibodies in baboons. The rhesus is an essential model for these antibody characterizations, since the rhesus cross-reacts with the fully humanized antibodies and has also been used in previous antibody studies by Protein Design Labs.
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