Wednesday, 19 December 2012

Tigenix announces excellent interim safety results of its Phase IIa Clinical Trial on Rheumatoid Arthritis

Today, Tigenix announced positive interim safety results of its Phase IIa study of Cx611 in patients with rheumatoid arthritis. Cx611 is an allogeneic product the company has been developing for the past years. It contains expanded stem cells extracted from the adiposal tissue of consenting donors.

The  hase IIa RA clinical trial is conducted at 23 centers with 53 patients participating. The trial is placebo controlled, and aims to assess safety, tolerance and optimal dosing of the drug. Tigenix researchers believe that the findings of the study may be useful for other autoimmune disorders as well.

The published interim results cover the first three months of the Phase IIa's six-month follow-up. According to the data, Cx611 seems to be safe in all three different doses that were checked for safety. As of now, only four patients (4%) have shown severe side effects and only one needed to discontinue the stem cell treatment. All the other recorded side effects were benign and brief.

Eduardo Bravo, Ceo of Tigenix, said:

"We are delighted to report that the safety profile of Cx611 appears to be excellent,"

And added that safety alone is not enough as they still need to prove the drug's efficiency.

"We have recruited patients who have failed at least two biologicals. If, in addition to this promising safety data, we can demonstrate a first indication of efficacy in this difficult to treat patient population, we will have a strong rationale to move forward with this product."

The study's results will be available at the end of April 2013.

Tigenix is a Spanish cell therapy company with a commercial product and an advanced clinical stage pipeline of adult stem cells programs. The company is particularly known for its ChondroCelect treatment, which is the first cell-based product to successfully complete the entire development track from research to clinical development in order to gain approval by the European Medicines Agency as an Advanced Medicinal Therapy Product.

Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder that mainly affects joints. Symptoms include swelling, stiffness and pain in the affected joint. It is estimated that around 1% of the world's population has rheumatoid arthritis.

Video about Rheumatoid Arthritis


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