Navigation Links
Tolerx Initiates Dosing of Otelixizumab, a Novel Type 1 Diabetes Agent, in DEFEND, a Phase 3 Clinical Trial

Milestone achievement triggers $15 million payment from collaborator


CAMBRIDGE, Mass., Aug. 6 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today announced the initiation of a pivotal Phase 3 clinical trial that is evaluating otelixizumab in autoimmune new onset type 1 diabetes. As a result of the initiation of patient dosing in DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), Tolerx will receive a $15 million milestone payment from GlaxoSmithKline.

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 in North America and Europe. The trial will 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. Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer hypoglycemic events, and a reduction in long-term disease complications in established type 1 diabetics in the Diabetes Control and Complications Trial (DCCT).

"We are excited to have dosed the first patient in DEFEND and look forward to continued patient enrollment in this Phase 3 clinical trial. The initiation of DEFEND represents the culmination of a methodical, dose-ranging development plan, including the successful outcome from an end-of-Phase 2 meeting at FDA. We believe otelixizumab has the potential to provide an important new treatment option for patients with newly diagnosed autoimmune type 1 diabetes," said Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx.

For additional information about DEFEND, please visit

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. The decrease in endogenous (natural) insulin production means that patients must monitor their glucose levels frequently and take insulin regularly to control their blood glucose levels.

About Otelixizumab

Otelixizumab is a monoclonal antibody that binds to CD3, a T lymphocyte receptor involved in normal cell signaling. Otelixizumab is thought to work by blocking the function of effector T cells that attack the body's tissues and cause autoimmune disease while inducing a subset of T cells known as regulatory T cells. It is thought that the regulatory T cells may protect against effector T cell damage well after the antibody has been eliminated from the body. In addition to DEFEND, Tolerx is also continuing to evaluate otelixizumab in subjects with type 1 diabetes in its ongoing Phase 2 study, TTEDD (TRX4 Therapeutic Evaluation of Different Dosing Regimens). A principal purpose of TTEDD is to evaluate different dosing regimens in an effort to reduce side effects and to acquire additional information about otelixizumab's clinical activity. Tolerx has conducted dose optimization studies in type 1 diabetes and has identified a dosing regimen that thus far has significantly reduced side effects while maintaining important biological activity. This dosing regimen is being used in DEFEND. For more information on DEFEND, please see

Tolerx Collaboration with GlaxoSmithKline

In October 2007, Tolerx and GlaxoSmithKline (GSK) entered into a global alliance to develop and commercialize otelixizumab in numerous indications, including type 1 diabetes. Under the terms of the agreement, Tolerx is responsible for conducting the Phase 3 clinical program for type 1 diabetes in the US and if successful, for submitting the biologics license application (BLA) to the FDA. Tolerx has the option to co-promote otelixizumab in type 1 diabetes in the US with GSK while GSK has exclusive rights to develop and commercialize otelixizumab in all other indications worldwide, including pediatric type 1 diabetes.

About Tolerx

Tolerx is a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases. Tolerx currently has two antibodies in clinical development: otelixizumab and a modified version of TRX1, MTRX1011A. MTRX1011A is a humanized anti-CD4 monoclonal antibody being developed in collaboration with Genentech, Inc. Tolerx is also engaged in preclinical development of new monoclonal antibody product candidates that engage the body's immune system and promote and enhance immune responses. These antibodies are being assessed for potential benefit in the treatment of cancer, chronic viral diseases, and as an adjunct to vaccines. For more information, please visit

Tolerx Forward-Looking Statements

This press release contains certain statements that are preceded by, followed by, or that include the words "will evaluate," "will," "look forward," "believe," and "has the potential to," 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 (the "Reform Act"). Statements regarding the outcomes sought to be realized in the Phase 3 clinical trial, the possibility that otelixizumab may have the potential to change type I diabetes treatment paradigms, the anticipated progress and development of otelixizumab, in type 1 diabetes and other disease indications, 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 impact management's expectations and affect the forward-looking statements shall include but not be limited to results of DEFEND and other future clinical studies, the ability to obtain regulatory approval for otelixizumab for type 1 diabetes or any other indication, the continuation of the collaboration with GSK, the introduction of competing therapies by other companies, and changes in the company's business plan or objectives. These statements reflect the view of Tolerx as of the date of this press release and should not be relied upon as reflecting the company's views at any date subsequent to this release. 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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Tolerx Achieves Milestone with Completion of Phase Ib Clinical Study of TRX1 in Cutaneous Lupus Erythematosus
2. Tolerx Advancing Novel Type 1 Diabetes Agent into Phase III Clinical Trial Program Following End of Phase II FDA Meeting
3. Tolerx Announces Achievement of Milestones upon anti-CD4 Antibody Program Advancement and Initiation of Phase 1 Clinical Trial
4. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
5. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
6. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
7. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
8. MedImmune Initiates Phase 2a Multi-Dose Study in Patients with Asthma
9. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
10. Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
11. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
Post Your Comments:
(Date:11/25/2015)... AVIV, Israel , November 25, 2015 ... (NASDAQ: KTOV ) (TASE: KTOV), a biopharmaceutical company ... simultaneous treatment of various clinical conditions, today announced the ... 3,158,900 American Depository Shares ( ADSs ), each representing ... purchase up to 3,158,900 ADSs. The ADSs and warrants ...
(Date:11/25/2015)... -- Trovagene, Inc. (NASDAQ: TROV ), a developer of ... Antonius Schuh, Ph.D., is scheduled to present a corporate ... Healthcare Conference. th Annual Piper Jaffray ... New York on Tuesday, December ... be available for one-on-one meetings during the conference. The ...
(Date:11/25/2015)... DUBLIN , Nov. 25, 2015 ... global pharmaceutical company, and Rugen Therapeutics, a start-up ... treatments for unmet CNS disorders and funded by ... that they have entered into an exclusive collaboration ... therapies for Autism Spectrum Disorders (ASD) and Obsessive ...
Breaking Medicine Technology:
(Date:11/24/2015)... Mississauga, ON (PRWEB) , ... November 24, 2015 , ... ... Deborah Williams without a referral for dental implants at her Mississauga, ON ... qualified and experienced in the placement of dental implants. , Missing teeth can ...
(Date:11/24/2015)... ... November 24, 2015 , ... ThirdLove, the fast-growing ... a week early, offering 40% off select bras and underwear styles, now through ... both mobile fit technology and the latest fashion, quickly becoming the next generation ...
(Date:11/24/2015)... ON (PRWEB) , ... November 24, 2015 , ... DMG ... with Ed Begley Jr., airing first quarter 2016 via Discovery Channel. Dates and show ... of the Province, and is in the business of producing and supplying medical marijuana ...
(Date:11/24/2015)... ... November 24, 2015 , ... It takes only three ... business, it is critical that the first impression be positive and reflects business values. ... likely to buy anything or want to return. They will also share their thoughts ...
(Date:11/24/2015)... FL (PRWEB) , ... November 24, 2015 , ... In ... a growing epidemic as deaths from prescription opioids in the United States grew 400 ... cocaine. In 2013 alone, opioids were involved in 37 percent of all fatal drug ...
Breaking Medicine News(10 mins):