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Tolerx Achieves Milestone with Completion of Phase Ib Clinical Study of TRX1 in Cutaneous Lupus Erythematosus
Date:1/15/2008

CAMBRIDGE, Mass., Jan. 15 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for the treatment of immune-mediated diseases, announced today the successful completion of a Phase Ib clinical study of TRX1, a novel humanized anti-CD4 monoclonal antibody (MAb), in subjects with refractory cutaneous lupus erythematosus (CLE). The Phase Ib study was designed to assess the safety, tolerability, and pharmacokinetics of TRX1. Tolerx has received a milestone payment from Genentech, Inc. in conjunction with the completion of this study.

Tolerx and Genentech entered into a collaboration in 2002 to develop and commercialize certain anti-CD4 monoclonal antibodies, including TRX1. Pursuant to this arrangement, Genentech may undertake the further development, manufacturing, and commercialization of those anti-CD4 molecules in any indication. The agreement provides for Tolerx to potentially receive development and regulatory milestone payments. In addition, Tolerx can receive royalties on worldwide net sales of those anti-CD4 antibodies and has the option to participate in a loss and profit sharing arrangement with Genentech in the United States.

Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx, commented, "This is an exciting next step in our effort to define new treatment paradigms for patients afflicted with immune-mediated diseases. The clinical data from the Phase Ib study provides us with optimism for the continued advancement of our anti-CD4 antibody programs, and we remain excited about our collaboration with Genentech."

About TRX1

TRX1 is a novel humanized monoclonal antibody (MAb) that binds to the CD4 receptor found on both T effector cells and T regulatory cells. TRX1 is expected to block the activation and function of T effector cells and to favor dominance of T regulatory cells. This process, referred to as down regulation of the immune system, r
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SOURCE Tolerx, Inc.
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