TiGenix (NYSE Euronext: TIG) Rheumatoid Arthritis P2a study passes Safety Hurdle
The safety data of the 1st 3 patients of the 3rd cohort of the P2a clinical trial in rheumatoid arthritis (Cx611) has received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining patients of this cohort.
- 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.
The Bottom Line: A key milestone, the higher dose in the P2a trial in RA is safe. TIG will not be held back by any dose-limiting factors and will be able to move forward with the optimal treatment dose. But of almost equal importance is the dosing range can be expanded in other indications. 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 P2a 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 with the expectation of final results to be available in the first half of 2013.