BTG plc: Tolerx initiates dosing of otelixizumab in a phase III clinical trial in type 1 diabetes

Tolerx to pay milestone of $7.5 million to BTG

08-Aug-2008

BTG plc notes the announcement by Tolerx, Inc. that it has initiated a pivotal phase III clinical trial of otelixizumab (TRX4) in patients with new onset type 1 diabetes. Initiation of the DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes) triggers a milestone payment by Tolerx to BTG of $7.5m.

The DEFEND trial, which is being conducted at multiple centres in North America and Europe, will enrol approximately 240 people aged 18-35 who have been newly diagnosed with type 1 diabetes. It will evaluate whether a single course of TRX4, administered no later than 90 days after the diagnosis of autoimmune type 1 diabetes, can inhibit the destruction of pancreatic beta cells and thereby reduce the amount of administered insulin required to control blood glucose levels. The primary endpoint will be a measurement of C-peptide, which is a surrogate measure of beta cell function.

BTG granted Tolerx worldwide rights to develop and commercialise TRX4 in September 2001. In October 2007, Tolerx entered into an agreement with GlaxoSmithKline to develop and commercialise TRX4 in a range of autoimmune and immune-mediated inflammatory diseases. Under the terms of that collaboration, Tolerx may earn development and sales milestone payments of up to $525m and BTG is entitled to receive 50% of the development and sales milestones paid to Tolerx.

https://www.bionity.com/en/news/85549/btg-plc-tolerx-initiates-dosing-of-otelixizumab-in-a-phase-iii-clinical-trial-in-type-1-diabetes.html