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TcLand Expression Launches the "PRINT" International Clinical Trial to Validate its Blood Biomarker RA-INF-Dx and Announces the Recruitment of its First Patient


2/22/2011 9:41:01 AM

Nantes (France), February 22nd, 2011 - TcLand Expression SA, a leading company focused on gene expression biomarkers in immunology and personalized medicine, today announced the launch of the PRINT trial ("Predicting non-response to infliximab therapy") and the recruitment of its first patient in a French rheumatology center. PRINT is a prospective, international, multicenter trial seeking to validate the blood-based biomarker RA-INF-Dx as a predictive, multigene molecular diagnostic for identifying rheumatoid arthritis patients who are unlikely to respond to infliximab (Remicade®), a monoclonal antibody targeting tumor necrosis factor (TNF). In all, 200 patients will included in the study by around 25 investigating centers in 7 European countries.

"The RA-INF-Dx predictive blood test will constitute a major step forward in the management of rheumatoid arthritis patients. RA-INF-Dx will help to optimize treatment with infliximab by identifying non-responder patients prior to the initiation of anti-TNF therapy. This will enable clinicians to offer patients the most suitable treatment option, reduce the incidence of potential short- and long-term side effects and thus positively influence quality of care and overall healthcare costs", emphasized Patrick Larcier, Vice President of Clinical and Regulatory Affairs at TcLand Expression.

The PRINT study will meet stringent regulatory requirements and the results will reinforce the company’s assets in the field of autoimmune diseases and its potential for collaboration with a range of healthcare players. TcLand expects the RA-INF-Dx test to be commercialized in 2012.

The early prediction of patient responses to biologics is a major challenge in autoimmune disease in general and in rheumatology in particular. This type of decision support will enable treatments to be matched to an individual patient's disease status.

About rheumatoid arthritis

The chronic, progressive, debilitating auto-immune disease rheumatoid arthritis is a major public health concern and affects approximately 1% of the population worldwide. Despite significant progress in the treatment of rheumatoid arthritis over the last 10 years, many patients remain partial responders and true remission is rarely achieved. A major goal in the field is prediction of the treatment response to prior to initiating a new therapy, with a view to optimizing patient care, reducing the risk of adverse effects or joint destruction and positively influencing overall healthcare costs.

About TcLand Expression

TcLand Expression is a recognized pioneer in the discovery, development and validation of gene expression biomarkers for unmet medical needs in immunology. The company benefits from an exceptional scientific and clinical environment. For more information, please visit our website: www.tcland-expression.com

Contacts

Alain Huriez, CEO TcLand Expression Phone: +33 2 40 35 89 99 ahuriez@tcland-expression.com

ine Carmagnol RP 6 64 18 99 59 caroline@alizerp.com ophie Cosquéric 42 68 86 41 / anne-sophie@alizerp.com



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