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Single Short Course of Tolerx’s Otelixizumab Provides Prolonged Preservation of Beta Cell Function
Four -Year
Follow-Up Study of Otelixizumab Published in Diabetologia Is the First
Placebo-Controlled Demonstration of Long Term Data
CAMBRIDGE, MA – March 16, 2010 - Tolerx, Inc., today announced the publication in Diabetologia, the journal of the
European Association for the Study of Diabetes, of the four-year follow-up clinical
data from new onset type 1 diabetes (T1DM) patients (age 12-39) who received a single
short course of therapy with otelixizumab (ChAglyCD3). In this clinical study conducted by the Juvenile
Diabetes Research Foundation (JDRF) Center for Beta Cell Therapy in Diabetes
based in
The
study results reported in Diabetologia were obtained through a collaboration
between clinical and laboratory researchers in
“The availability of four year efficacy and safety data with otelixizumab further advances our clinical development program in type 1 diabetes,” said Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx. “Tolerx is grateful to all the patients, caregivers, clinical trial investigators, and the JDRF for conducting and funding this study. Tolerx is excited to be continuing the development of otelixizumab, and we look forward to very shortly initiating our second Phase 3 trial (DEFEND-2) in new onset autoimmune type 1 diabetes.”
Dr.
Daniel Pipeleers, Director of the JDRF Center Brussels commented “Our data
provide strong support to a novel disease modifying treatment for new-onset
T1DM patients. The data showed that
immune modulation by otelixizumab dampen the autoimmune destruction process
thereby preserving residual beta cells and their contribution to glycemic
control.”
In this reported study, otelixizumab administration was associated with transient symptoms during dosing including flu-like syndrome and transient perturbation of Epstein Barr Virus (EBV). During the 48 months of follow-up there were no EBV related symptoms, no higher incidence of infections, and no lymphoproliferative or other types of cancer observed. Following the 18 month efficacy results of the present study, Tolerx has optimized the otelixizumab dosing regimen to minimize adverse events, with encouraging data on clinical effect. This optimized dosing regimen is now being fully evaluated in a Phase 3 clinical study called DEFEND-1, which completed enrollment in January 2010, and will be confirmed in a second pivotal study, DEFEND-2. DEFEND-2 is intended to begin in the first half of 2010.
About the Study
The multicenter study included 80 patients with new onset diagnosed with type 1 diabetes. Patients in the study were randomly assigned to receive either otelixizumab (then called ChAglyCD3) or placebo for six consecutive days. During the 48 months following treatment, patients were monitored for daily insulin needs and endogenous insulin production as assessed by measuring C-peptide release induced by an intravenous glucose infusion. At 6, 12, 18, 24, 36 and 48 months, beta cell function was more effectively maintained in otelixizumab-treated subjects than in placebo-treated patients. Data on the first 18 months have been published in N Engl J Med, 23, 2598, 2005. The 48 months data has been published in Diabetologia, 53, 614-623, 2010 (www.diabetologia-journal.org).
About DEFEND
DEFEND-1 is a randomized, placebo-controlled Phase 3 study
that has achieved its target enrollment of 240 patients, age 12 to 45, with
newly diagnosed autoimmune type 1 diabetes.
DEFEND is being conducted at over 100 centers throughout Europe and
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 involving 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 targeted T cell immunomodulator 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' ability to make insulin.
About Tolerx
Tolerx, Inc., a world leader in the understanding of T
cell function, is developing novel therapies intended to treat autoimmune
diseases, diabetes, and cancer by specifically modulating T cell
activity. The company’s pipeline includes its lead candidate,
otelixizumab, a targeted T cell immunomodulator in Phase 3 development for the
treatment of type 1 diabetes that is partnered with GlaxoSmithKline. TRX1, a Phase 1 candidate, is a nonlytic anti-CD4
antibody that is being developed for the treatment of aberrant or untoward immune
responses, and there are three pre-clinical candidates, TRX518, TRX585 and
TRX385, that enhance immune responses and as such are being evaluated for
potential benefit in the treatment of cancer and chronic infections. Tolerx
is a privately held company headquartered in