CAMBRIDGE, Mass., June 3 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today announced that two abstracts from its otelixizumab program have been accepted and will be presented at the American Diabetes Association 68th Scientific Sessions (ADA) in San Francisco, CA.
Michael Rosenzweig, DVM, Ph.D., Senior Director of Preclinical Research at Tolerx, will present "PD Parameters that Measure Alterations in T Cell Populations are Predictors of the Therapeutic Benefit of Anti-CD3 Therapy in Diabetic NOD Mice" Abstract #271-0R in the oral presentation session "Therapeutic Interventions in Type 1 Diabetes" at 9:30 a.m. (Pacific) on June 9, 2008.
Additionally, Daron Forman, Ph.D., Senior Scientist at Tolerx, will present "Otelixizumab Induces Expansion of Human CD4+FoxP3+ Cells in vitro and in vivo" Abstract # 518-P: Category 01-D Clinical Therapeutics/New Technology - Pharmacologic Treatments of Diabetes or its Complications in the poster session beginning June 7, 2008 continuing through June 9, 2008.
Otelixizumab is a monoclonal antibody that binds to CD3, a T lymphocyte receptor involved in normal cell signaling. Tolerx is currently evaluating otelixizumab in subjects with new-onset type 1 diabetes in a phase 3 clinical trial referred to as DEFEND (Durable-response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes). Additionally, Tolerx is continuing the evaluation of multiple dose regimens and administration duration of otelixizumab in an ongoing phase 2 study referred to as TTEDD (TRX4 Therapeutic Evaluation of Different Dosing Regimens) in subjects with type 1 diabetes.
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, which is being developed in collaboration with GlaxoSmithKline and TRX1. TRX1 is a humanized anti-CD4 monoclonal antibody being developed in collaboration with Genentech, Inc. Tolerx is also engaged in preclinical development of new product candidates that circumvent immune system tolerance. These product candidates are being evaluated for the treatment of cancer or chronic viral diseases. For more information, please visit www.tolerx.com.
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. Pursuant to that arrangement, 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.
Tolerx Forward-Looking Statements
This press release contains certain statements that are preceded by, followed by, or that include the words "will be," "if successful" 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 outcomes sought to be realized in the clinical trials or preclinical development, 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. There can be no certainty that Tolerx will advance any clinical candidate or other component of its pipeline to the clinic, to the next regulatory step or to commercialization. Factors and risks that may impact management's expectations and affect the forward-looking statements include but are not be limited to results of TTEDD or DEFEND and other future clinical studies, results of pre-clinical studies, the ability to obtain regulatory approval for advancement of any product candidate, the continuation of the collaborations with GSK and Genentech, 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.