TiGenix (NYSE Euronext: TIG) Rheumatoid Arthritis P2a study passes Safety Hurdle
The independent Safety Monitoring Board has approved further dosing to recruit and dose the remaining patients of this cohort.
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.
