BTG Drug Developed By Glaxo And Tolerx Misses Study End Point
March 11 2011 - 11:04AM
Dow Jones News
GlaxoSmithKline PLC (GSK) and U.S. partner Tolerx, Inc. said
Friday their experimental drug otelixizumab failed to achieve its
target in a late-stage clinical trial for Type 1 diabetes.
The two companies in a joint statement said otelixizumab, an
investigational anti-CD3 monoclonal antibody for treating adults
with newly diagnosed Type 1 diabetes, did not meet the primary
endpoint set for a Phase III study named DEFEND-1.
Glaxo said it plans to explore additional dosing regimens in the
light of the outcome. New recruitment and dosing in a second
similar clinical study named DEFEND-2 has been suspended pending
review of the results.
Otelixizumab is being developed in collaboration with Glaxo and
Tolerx. The drug candidate is licensed in from U.K.-based BTG PLC
(BGC.LN).
Louise Makin, BTG's chief executive, said in a statement that
"the result of the DEFEND-1 study is obviously disappointing,
though we note that GSK is continuing development of otelixizumab
in autoimmune diseases."
Glaxo and Tolerx in Oct. 2007 set up alliance to develop and
commercialize otelixizumab for a range of autoimmune and
immune-mediated inflammatory diseases, including type 1
diabetes.
Under the deal, Tolerx is responsible for the clinical and
regulatory activities for otelixizumab in type 1 diabetes in the
U.S. and has the option to co-promote otelixizumab in type 1
diabetes in the U.S. with Glaxo, while the U.K. drug maker has
exclusive rights to develop and commercialize otelixizumab in all
other indications in the rest of the world. Glaxo also has the
exclusive right to develop the pediatric indication for type 1
diabetes in the U.S.
-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292;
sten.stovall@dowjones.com
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