Tolerx Achieves Milestone with Completion of Phase Ib Clinical Study of TRX1 in Cutaneous Lupus Erythematosus

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, results in hyporesponsiveness, or tolerance, to antigens. In a preclinical study in a primate model, administration of TRX1 during the development of a primary immune response to a foreign protein, or antigen, resulted in longstanding and specific tolerance to that antigen. This type of suppression of the immune system may have therapeutic benefit in treating autoimmune diseases that occur when the human immune system mistakenly identifies the components of the human body as foreign.

About Tolerx

Tolerx is a biopharmaceutical company engaged in the discovery and development of novel therapies for the treatment of patients with immune- mediated diseases. In addition to the development of TRX1, Tolerx is currently developing otelixizumab, an anti-CD3 MAb, in type 1 diabetes with its collaboration partner, GlaxoSmithKline. Tolerx is also engaged in preclinical development of new MAb product candidates that engage the body's immune system and further promote and enhance immune responses. This type of therapy is being researched for the treatment of cancer and chronic viral diseases.

Safe Harbor Statement

This press release contains certain statements that are preceded by, followed by, or that include the words "if," "will receive," "is expected to," "may have" or similar expressions or the negation thereof. Such statements, which are not historical facts, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements regarding Genentech's activities with respect to further development of TRX1, the potential value of payments that may be received by Tolerx pursuant to the agreement with Genentech, and the anticipated progress and development of TRX1 are all forward-looking statements. Such forward- looking statements involve risks, uncertainties and other factors that may cause the actual performance or achievements of Tolerx to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Factors and risks that may affect the forward-looking statements include the results of future clinical studies, the ability to obtain regulatory approvals for TRX1 and the introduction and impact of competing therapies by other companies. These statements reflect the view of Tolerx as of the date of this press release, and Tolerx undertakes no obligation to update or revise any forward-looking statements to reflect events or circumstances after the date of this press release.

SOURCE Tolerx, Inc.

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