TiGenix : positive Phase IIa study results in refractory rheumatoid arthritis with allogeneic stem cell product Cx611

Regulated information April 22, 2013

TiGenix reports positive Phase IIa study results in refractory rheumatoid arthritis with allogeneic stem cell product Cx611

Management will conduct a conference call to discuss the results today at 4pm CET, 10am EST Dial-in numbers are provided at the end of this press release

Leuven (BELGIUM) - April 22, 2013 - TiGenix (NYSE Euronext: TIG), the European leader in cell therapy, today announced positive 6-month safety data of its Phase IIa study of Cx611 in rheumatoid arthritis (RA), as well as a first indication of therapeutic activity on standard outcome measures and biologic markers of inflammation for at least three months after dosing.

The multicenter, randomized, double blind, placebo-controlled Phase IIa trial enrolled 53 patients with active refractory rheumatoid arthritis (mean time since diagnosis 15 years), who failed to respond to at least two biologics (mean previous treatment with 3 or more disease-modifying antirheumatic drugs and 3 or more biologics). The study design was based on a three-cohort dose-escalating protocol. For both the low and medium dose regimens 20 patients received active treatment versus 3 patients on placebo; for the high dose regimen 6 patients received active treatment versus 1 on placebo. Patients were dosed at day 1, 8, and 15 and were followed up monthly over a six-month period. Follow-up consisted of a detailed monthly workup of all patients measuring all pre-defined parameters. The aim was to evaluate the safety, tolerability and optimal dosing over the full 6 months of the trial, as well as exploring therapeutic activity.

Only one patient suffered serious adverse events that led to discontinuation of the treatment. All other side effects were mild and transient. Importantly, the first results show no signs of hematological side effects or thrombosis.

Measured clinical activity scores were ACR20(1), ACR50(1), ACR70(1), EULAR(2) response rates, and the disease activity score DAS28(3). To gain a first insight into the therapeutic activity, these parameters were evaluated every month for six months. The below tables reflect cumulated results in percentages of all three active treatment arms at months 1 (M1), 2 (M2), 3 (M3), and "final visit" (FV). A more detailed analysis is currently ongoing.

For all graphs, N=46 for Cx611 and N=7 for placebo.

Please click on the link at the bottom of the message to see the table ("Table1").

"This Phase IIa cell therapy trial is a landmark study that gives us a first indication of the potential of cell therapy in rheumatoid arthritis. The positive safety results combined with a new mechanism of action are promising, and warrant further clinical investigation," said Dr. Jos Mara lvaro-Gracia, MD, PhD, Head of the Biological Therapies Unit at the Hospital Universitario de La Princesa, Madrid, Spain, and Principal Investigator of the study.

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TiGenix : positive Phase IIa study results in refractory rheumatoid arthritis with allogeneic stem cell product Cx611

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