TiGenix announced today that it has received the go-ahead from the independent Safety Monitoring Board to move into the randomized stage of the company’s Phase IIa clinical trial in rheumatoid arthritis (Cx611). This decision is based on the analysis of the safety data from patients treated in the study’s first cohort.
“We are very pleased with achieving this milestone,” said Eduardo Bravo, CEO of TiGenix. “This confirms our position at the forefront of the stem cell field in Europe. We believe our platform holds great promise for treating a wide range inflammatory and immune disorders.”
About Cx611 for rheumatoid arthritis
Cx611 is a suspension of expanded allogeneic adult stem cell product derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or ‘eASCs’) that is delivered through intra-venous injection for the treatment of rheumatoid arthritis. The objective of the Phase Ib/IIa trial is to determine safety, feasibility, tolerance, and optimal dosing. This multicentre, placebo-controlled study will involve approximately 53 patients, divided in 3 cohorts with different dosing regimens. There are more than 20 centres open and the company expects the final results to be available in the first half of 2013.
TiGenix NV is a leading European cell therapy company with two marketed products, ChondroCelect and ChondroMimetic, and a strong pipeline with clinical stage adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium), and Madrid (Spain), and has facilities in Cambridge (UK) and Sittard-Geleen (the Netherlands).
For more information please visit www.tigenix.com.