Cambridge, Massachusetts (ots/PRNewswire)
- Tolerx, Inc.,
today announced the completion of patient enrollment in its Phase 3
clinical study DEFEND-1, which is evaluating the safety and efficacy
of otelixizumab, a targeted T cell immunomodulator, in patients with
new-onset autoimmune type 1 diabetes.
The DEFEND-1 (Durable Response Therapy Evaluation For Early or
New-Onset Type 1 Diabetes) study enrolled 240 patients, aged 12-45
years with newly diagnosed autoimmune type 1 diabetes. The DEFEND-1
study is investigating the ability of otelixizumab to preserve beta
cell function, which may reduce the risk of both short- and long-term
complications of the disease. Patients will be monitored during the
12-month follow-up period and c-peptide levels (a surrogate measure
of beta cell function) will be measured as the primary endpoint.
Secondary endpoints will evaluate the patient's ability to maintain
excellent glycemic control as measured by HbA1c levels and the amount
of daily injected insulin required.
Dr. Paolo Pozzilli, Professor of Endocrinology & Metabolic
Diseases at the University Campus Bio-Medico in Rome, Italy, and a
DEFEND-1 investigator commented: "Reaching full enrollment in
DEFEND-1 is a major accomplishment for the type 1 diabetes community
and furthers the development of innovative immunomodulating therapies
for our patients. We will continue to work with Tolerx to further
otelixizumab's clinical development and to validate its promise of
beta cell preservation in new-onset autoimmune type 1 diabetes
Peter A. Gottlieb, MD, Associate Professor of Pediatrics and
Medicine at the Barbara Davis Center at the University of Colorado at
Denver, known for his involvement in many types of clinical trials
for the prevention and treatment of diabetes, noted that, "The
continuous otelixizumab dose regimen optimization efforts have been a
major translational research focus. These important research efforts
are enabling us, in the DEFEND development program, to evaluate the
potential ability of otelixizumab to provide a long-term immunologic
remission after a short course of therapy. If successful in the
clinic, this would be a significant step forward."
Tolerx also announced today its intention to conduct a second
confirmatory Phase 3 study of otelixizumab in new-onset autoimmune
type 1 diabetes. Further details of the design and timing of the
study, to be named DEFEND-2, will be forthcoming.
"The on-time completion of patient enrollment in DEFEND-1
represents a major milestone for Tolerx," said Dr. Douglas J.
Ringler, President and Chief Executive Officer of Tolerx. "We are
very grateful for the dedication of the patients, their caregivers
and our clinical trial investigators for making it possible to reach
our enrollment target. As part of our clinical development program to
reach regulatory approval for otelixizumab, we will now quickly
transition to the launch of DEFEND-2, a confirmatory study, to
maintain enrollment momentum and enthusiasm generated to date in the
type 1 diabetes community."
About the DEFEND-1 Study
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 study centers throughout Europe and North
America. The study 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 preserve beta cell
function as measured by c-peptide, a surrogate measure of beta cell
function. The primary endpoint is measurement of c-peptide. For more
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.
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.
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 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
ots Originaltext: Tolerx, Inc.
Im Internet recherchierbar: http://www.presseportal.ch
CONTACT: Jessica Johnson of Tolerx, Inc., +1-617-452-1356