Tolerx, Inc., a
biopharmaceutical company engaged in the discovery and development of novel
therapies for the treatment of immune-mediated diseases, announced
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.
Tolerx, Inc.
tolerx