Tolerx Expands Phase 3 'DEFEND' Trial of Otelixizumab in Europe

Cambridge, Massachusetts (ots/PRNewswire) -

Tolerx, Inc., today announced that DEFEND (Durable Response
Therapy Evaluation For Early or New Onset Type 1 Diabetes), the Phase
3 trial of otelixizumab, an investigational novel targeted
immunotherapeutic, has begun enrollment of new onset autoimmune type
1 diabetes patients in Europe. In DEFEND, preserving beta cell
function subsequent to the administration of otelixizumab is the
primary outcome that is being evaluated. This outcome will be
assessed by measuring C-peptide levels (a surrogate of endogenous
insulin secretion) and by measuring reductions in the amount of
injected insulin used to maintain excellent glycemic control.

DEFEND continues to actively recruit subjects in the United
States, Canada, Sweden, Finland, Germany, Italy, and the UK. Tolerx
anticipates that enrollment will soon commence at clinical sites in
Spain and Denmark.

"Our participation in DEFEND reflects our research priorities to
support the development of innovative immune intervention for type 1
diabetes patients. We have begun dosing otelixizumab in DEFEND and
are excited about its potential to be an effective treatment option
for type 1 diabetics," stated Dr. Paolo Pozzilli, Professor
University Campus Bio-Medico, Rome Italy.

"We are pleased that an increasing number of excellent clinical
researchers in Europe and North America have started DEFEND at their
sites and look forward to their continued participation in this
important effort. We believe that a single short course of
otelixizumab may have the potential to preserve residual beta cell
function and offer people with autoimmune type 1 diabetes improved
disease control" said Dr. Louis Vaickus, Chief Medical Officer of
Tolerx. He continued "We are seeking in DEFEND to conclusively
demonstrate this understanding."

About the DEFEND Study

DEFEND is a randomized, placebo-controlled Phase 3 trial designed
to enroll approximately 240 adult patients, age 18 to 35, with newly
diagnosed autoimmune type 1 diabetes. DEFEND is being conducted at
multiple centers throughout Europe and North America. The trial is
designed to evaluate whether a single course of otelixizumab,
administered not more than 90 days after the initial diagnosis of
autoimmune type 1 diabetes, will reduce the amount of administered
insulin required to control blood glucose levels by inhibiting the
destruction of beta cells. The primary endpoint will be a measurement
of C-peptide, a surrogate measure of beta cell function. For
additional information about DEFEND, please visit
www.DefendAgainstDiabetes.com

About Type 1 Diabetes

Diabetes (medically known as diabetes mellitus) is the name given
to disorders in which the body has difficulty regulating its blood
glucose (sugar) level. There are two major types of diabetes: type 1
and type 2. Type 1, previously known as juvenile diabetes or
insulin-dependent diabetes, is a disorder of the body's immune
system. In type 1 diabetes, the immune system attacks and destroys
the insulin-producing beta cells in the pancreas. As a result of the
decrease in endogenous (natural) insulin production, patients must
monitor their glucose levels frequently and administer insulin
regularly to control their blood glucose levels.

About Otelixizumab

Otelixizumab is a novel monoclonal antibody being developed for
the treatment of type 1 diabetes and other autoimmune diseases.
Otelixizumab targets CD3, a T lymphocyte receptor involved in normal
cell signaling. Otelixizumab has not yet been approved for marketing.
Data suggest that the antibody may work in patients with type 1
diabetes who have residual beta cells by blocking the function of
effector T cells that mistakenly attack and destroy insulin-producing
beta cells, while stimulating regulatory T cells that are understood
to protect against effector T cell damage, thus preserving the beta
cells' normal ability to make insulin. For further information of how
otelixizumab may work, please see www.tolerx.com otelixizumab page
and watch our animation.

About Tolerx

Tolerx is a biopharmaceutical company engaged in the discovery
and development of novel therapies for immune-mediated diseases. The
company's pipeline includes its lead candidate, otelixizumab, an
anti-CD3 monoclonal antibody partnered with GlaxoSmithKline in Phase
3 development for the treatment of type 1 diabetes; a Phase 1
candidate, MTRX1011A, an anti-CD4 antibody that is being developed in
collaboration with Genentech, Inc. for the treatment of autoimmune
indications; and two pre-clinical candidates, TRX518 and TRX385, that
enhance immune responses and are being evaluated for potential
benefit in the treatment of cancer, chronic viral diseases, and as
vaccine adjuvants. Tolerx is a privately held company headquartered
in Cambridge, MA USA. For more information, please visit
www.tolerx.com.

Tolerx Forward-Looking Statements

This press release contains certain statements that are preceded
by, followed by, or that include the words "will," "will be,"
anticipates," "potential," "look forward," or similar expressions or
the negation thereof. Such statements, which are not historical
facts, constitute "forward-looking statements." Statements regarding
the outcomes sought to be realized in the DEFEND and the possibility
that otelixizumab may preserve beta cell function, may be a
potentially effective treatment option, or may constitute an
innovative immune intervention for type 1 diabetes, 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. Tolerx undertakes no obligation
to update or revise any forward-looking statements to reflect events
or circumstances after the date of this press release.

ots Originaltext: Tolerx, Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Jessica Snyder, Corporate Communications of Tolerx, Inc.,
+1-617-452-1300, jsnyder@tolerx.com