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TiGenix (NYSE Euronext: TIG) announced today that upon review of the safety data of the first three patients of the second cohort of the company's Phase IIa clinical trial in rheumatoid arthritis (Cx611) it has received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining 20 patients of this cohort and to open the third and final cohort. The Phase IIa trial is based on a three-step dose-finding protocol, where each step starts with a safety review of the first three patients after 40 days of dosing.
"We are very pleased with reaching the next stage in this Phase IIa trial on schedule," said Eduardo Bravo, CEO of TiGenix. "With each positive step forward that we take, in addition to promising results recently reported by other companies and research groups in the stem cell field, we are moving closer to the moment that stem cell therapies will be a mainstay of clinical practice, providing solutions for a wide range of unmet medical needs."
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 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 (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with two marketed products for cartilage repair, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), Cambridge (UK) and Sittard-Geleen (the Netherlands).
Source: TiGenix
Tags: clinical trials
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