TxCell SA has announced that activity and tolerance data for its second lead product Col-Treg were presented through a poster presentation at the 2015 ARVO Annual Meeting, May 3-7, 2015, in Denver, Colorado, US.
The presentation was delivered by Dr. Hélène Asnagli, Preclinical Pharmacology & Safety Director, in the session entitled ‘AMD immunobiology, autoimmunity, and immunoregulation’. The poster entitled ‘Immunotherapy of Non-Infectious Uveitis using Collagen II-specific regulatory Type 1 (Col-Treg) cells’ presented preclinical efficacy and tolerability results with Col-Treg in the treatment of autoimmune uveitis.
These results include pharmacokinetic and pharmacodynamic data showing a reduction in the severity of uveitis on clinical and histologic measures. In addition, TxCell has also generated GLP toxicology results that indicate a good safety profile for Col-Treg. Col-Treg is set to start a phase I/II placebo-controlled, dose-ranging proof of principle clinical study in autoimmune uveitis mid-2015. Col-Treg received orphan drug designation from the EU in December 2014.
Autoimmune uveitis is a rare debilitating inflammatory condition of the eye, often resulting in permanent vision damage. It is a leading cause of blindness in the developed world, with very limited treatment options.
Because of the relatively poor tolerance profile of the existing therapies and the increased resistance to these drugs, the development of new and safer class of therapeutics to treat autoimmune uveitis is essential.
“Presenting data for Col-Treg, its second lead product from its proprietary ASTrIA platform of cellular immunotherapy, at the 2015 ARVO Annual Meeting is an important milestone for the product and for TxCell. These preliminary efficacy and tolerance data warrant further development at the clinical stage," said Dr. Arnaud Foussat, VP Research and New Products, TxCell. “TxCell is currently working with clinicians and regulatory authorities to prepare the first clinical trial with Col-Treg. There are approximately 30,000 autoimmune uveitis patients per year that are refractory to approved treatments in the US and EU alone and this is a clear unmet medical need.”