Protein Design Labs, Inc. (PDL), is planning a phase II study to evaluate the ability of its SMART Anti-CD3 Antibody to prevent acute rejection in kidney transplantation.
The company will test the antibody in up to 40 patients in an open-label, multiple-dose, multicenter study. Patients also will receive standard immunosuppressive therapy, which generally will include tacrolimus, mycophenolate mofetil, and steroids. Investigators plan to study the safety of the antibody and the incidence of acute rejection episodes three and six months following transplantation.
The SMART Anti-Cd3 Antibody targets the CD3 antigen on lymphocytes, and it "differs from the marketed mouse anti-CD3 antibody in that it is humanized and has been modified using proprietary PDL technology to avoid the potentially serious cytokine release syndrome associated with the mouse antibody," PDL said in a statement.
"The phase I and phase I/II clinical trials … have shown that it provides profound, reversible T-cell depletion even at very low doses without causing serious adverse events," said Robert L. Kirkman, MD, of PDL.
The company also is evaluating the antibody in a phase I/II trial in severe psoriasis and in an investigator-sponsored trial for the treatment of acute graft versus host disease following bone marrow transplantation.
In other news, PDL and Hoffmann-LaRoche, Inc., have announced an agreement under which PDL will assume worldwide responsibility for the clinical development of Zenapax (daclizumab) for the treatment of autoimmune diseases. Zenapax is currently used to fight acute kidney rejection.
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