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| |  Zenapax/CellCept Combination Shows Fewer Rejections NUTLEY, N.J., and MOUNTAIN VIEW, Calif., May 14, 1997 -- Positive results were announced yesterday of a clinical trial evaluating Zenapax (dacliximab; SMART(TM) Anti-Tac) in combination with a standard drug regimen of CellCept (mycophenolate mofetil), cyclosporine and corticosteroids in kidney transplant patients. The data from the Phase I/II randomized, double-blind placebo-controlled study, looking at the safety, pharmacokinetics and preliminary efficacy of the combination regiment were presented at the Annual Scientific Meeting of the American Society of Transplant Physicians (ASTP) in Chicago. A total of 75 evaluable patients at five centers in the U.S. received the standard regimen including CellCept and 50 of the patients also received Zenapax. Zenapax was developed by Protein Design Labs, Inc., (PDL) who licensed exclusive worldwide rights to dacliximab to F. Hoffmann-La Roche Ltd., Basel, Switzerland, and Hoffmann-La Roche Inc., Nutley, NJ. The Clinical Trial Results Results show that the Zenapax/CellCept combination was well tolerated. There was a 12 percent incidence of acute rejection episodes within six months of transplantation in the patients receiving Zenapax and CellCept, compared with 20 percent in the control group receiving standard triple drug therapy. The latter rate was consistent with previous studies of CellCept. Roche is now planning clinical studies to evaluate the use of Zenapax and CellCept to reduce or eliminate the need for cyclosporine in kidney transplant recipients. "The four drug regimen including Zenapax and CellCept appears to achieve a very low incidence of rejection episodes that has not previously been obtained with other drugs and has an excellent safety profile," said Robert L. Kirkman, M.D., Chief, Division of Transplantation at Brigham and Women's Hospital in Boston. Dr. Kirkman presented the data and was one of the investigators of the trial. "We anticipate that Zenapax and CellCept together will become an important part of the standard regimen for the prevention of transplant rejection," said Franz B. Humer, Ph.D., Chief Operating Officer and Head of the Pharmaceutical Division of F. Hoffmann-La Roche Ltd. SMART Anti-Tac (dacliximab) is a humanized monoclonal antibody that is the active ingredient of Zenapax. SMART Anti-Tac binds to the alpha subunit of the high affinity interleukin-2 receptor (IL-2R) which is expressed on activated T cells. Zenapax inhibits binding of IL-2 to the high affinity IL-2 receptor, thus suppressing T cell activity against allografts. If approved by regulatory authorities, Zenapax will be marketed by Roche worldwide and Protein Design Labs will receive royalties based on sales. During 1996, PDL received fundamental U.S. and European patents covering humanized antibodies including dacliximab, and a U.S. patent for dacliximab. About Roche The Roche Group is a world leader in research-based health care with principal businesses in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. Roche has a long tradition of innovative breakthroughs in drug development and is a pioneer in medical applications of genetic engineering. About Protein Design Labs Protein Design Labs, founded in 1986, is developing human and humanized antibodies to prevent or treat a variety of autoimmune and inflammatory conditions, cancers and viral infections. PDL currently has three potential antibody products in clinical development in addition to Zenapax. PDL's human and computer-designed SMART (humanized) antibodies have a longer half-life and are less immunogenic than mouse antibodies, and PDL believes they will therefore be more useful as human therapeutics.
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