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TiGenix (NYSE Euronext: TIG) Rheumatoid Arthritis P2a study initiates third and last cohort
Go-ahead from the independent Safety Monitoring Board based on safety data
The first 3 patients of the 2nd cohort of the P2a clinical trial in rheumatoid arthritis (Cx611) were dosed while recruiting and dosing the remaining 20 patients will open the 3rd and final cohort.
- This multicentre, placebo-controlled study will involve approximately 53 patients, divided in 3 cohorts with different dosing regimens;
- There are more than 20 centers open and expectation of the final results to be available in the 1st ½ of FY13.
The Bottom Line: The P2a trial on schedule. The P2a trial is based on a 3 step dose-finding protocol, where each step starts with a safety review of the first 3 patients after 40 days of dosing. Cx611 for rheumatoid arthritis … 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 P2a trial is to determine safety, feasibility, tolerance, and optimal dosing.
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