Monday, 22 April 2013

Tigenix reports positive 6-month results from Phase II trial on patients with rheumatoid arthritis

Tigenix just announced positive 6-month safety results from its ongoing Phase IIa clinical trial on Cx611. Purpose of the trial is to test the drug's safety, efficacy and optimal dose in patients with active refractory rheumatoid arthritis that have failed to respond to at least two biologics products.

The double blind, placebo-controlled trial is conducted in 23 centres. A total of 53 patients, in three different cohorts, have received the Cx611 stem cell therapy (or placebo). Specifically:
  • 20 patients received low dose
  • 20 patients received medium dose
  • 6 patients received high dose
  • 7 patients received placebo treatment

According to the press release, Cx611 was shown to be safe in all three different doses, with only one patient experiencing serious adverse effects. All other side effects were minimal and benign. Additionally, the currently available data indicate some therapeutic activity, resulting from the treatment.

"We are delighted to report the positive outcome of our Phase IIa trial with Cx611 in RA, these results are remarkable, as they constitute the first ever signal of clinical activity of a cell therapy in RA. Moreover, this was achieved in the probably most refractory RA patient population ever evaluated in clinical studies. At the same time the outcome of the study provides unique clinical and laboratory insights to set the stage for further exploration of our eASC platform in RA and in other autoimmune and inflammatory diseases with high unmet medical needs." said Eduardo Bravo, CEO of TiGenix.

Eduardo Bravo talks about Tigenix and Cx611

Cx611 is an allogeneic product containing stem cells harvested from the adipose tissue of consenting donors. The drug is delivered through intravenous injection.

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You can read the official press release here

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