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TiGenix (NYSE Euronext: TIG) announced today that upon review of the safety data of the first three patients of the third 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 patients of this 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.
"With this last step, we have reached a key milestone in our Phase IIa trial in RA," said Eduardo Bravo, CEO of TiGenix. "The fact that the highest dose has proven safe is of major importance. In RA it ensures that we will not be held back by any dose-limiting factors and we will be able to move forward with the optimal treatment dose. But of almost equal importance is that, if required, we can expand the dosing range in other indications that we are exploring as well. With 6 months of follow-up, the current RA trial in 53 patients is expected to report meaningful results in H1 2013."
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 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 a marketed product for cartilage repair, ChondroCelect®, 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), and Sittard-Geleen (the Netherlands).
Tags: clinical trials