TiGenix completes recruitment of multinational Phase III clinical trial for cartilage repair

LEUVEN (BELGIUM) – January 10, 2005 – TiGenix announced today that it has successfully completed patient recruitment for its ChondroCelect® landmark trial: a prospective randomised multi-centre clinical trial comparing ChondroCelect® to the current standard of care (microfracture) in the repair of symptomatic cartilage defects of the knee.

ChondroCelect® is an innovative product for the functional repair of cartilage defects of the knee. It is an autologous cell therapy product characterised by its capacity to generate stable hyaline-like cartilage in vivo. The product is applied through Autologous Chondrocyte Implantation (ACI), a surgical procedure to treat cartilage defects. A cartilage biopsy is taken from a healthy part of the patient’s damaged knee and after expansion in TiGenix’ GMP (Good Manufacturing Practice) laboratory, the cells are implanted back into the cartilage defect, where they can form new cartilage.

“At TiGenix we are very proud of this landmark clinical trial, designed to establish ChondroCelect® as a first line therapy for the treatment of symptomatic cartilage defects of the knee”, says Gil Beyen, CEO.

TiGenix’ Phase III clinical trial (“TIGACT 01”) is the world’s first prospective, controlled, randomised, multinational and multi-centre study in the repair of difficult to treat cartilage defects in the knee enrolling such a large patient population.

The anticipated target enrolment of 112 patients has been overachieved: since the beginning of the study, 118 patients have been recruited in 12 hospitals in Belgium, Croatia, France, Germany and the Netherlands. The study is blinded for the primary endpoint and results will only be released when all patients will have reached the one year postoperative endpoint. A longterm yearly follow-up is planned over a five year period. The trial is monitored by the in-house TiGenix clinical staff with the support of Quintiles.

“To the best of my knowledge this is the world’s first prospective randomised study of this size and quality in joint resurfacing procedures and the repair of articular cartilage defects. The trial data will be available early 2006, and we are looking forward to see those results”, says Professor Johan Bellemans, one of the principal investigators, from the University Hospitals in Leuven.

About TiGenix
TiGenix was founded in 2000 as a spin-off of the Universities of Leuven and Gent. The company operates at the cutting edge of regenerative medicine and focuses on the development of innovative local treatments for damaged and osteoarthritic joints. Joint surface damage and osteoarthritis are affecting a very large population and are the leading cause of disability at older age. Cartilage is a tissue with limited spontaneous healing capacity. A defect in the cartilage surface in a joint will not heal in most cases, but slowly lead to the degeneration of the joint.

TiGenix has developed new therapeutic approaches aiming at repairing the articular cartilage by implanting well-defined and characterized cartilage-forming cells, derived from the patients’ own tissues. The company has discovered specific molecular markers, which are used to select and deliver a cell population capable of forming stable hyaline-like cartilage in vivo, resistant to bone and blood vessel formation. TiGenix’ lead product, ChondroCelect® is based on this discovery and aims to be the first product to claim durable repair of full thickness cartilage defects.

In September 2003, TiGenix closed a series A financing of € 12 million with four leading European venture capital funds (ING Private Equity, Auriga Venture Partners, Fagus-Fortis Private Equity and Capricorn Venture Partners).

For more information you can visit our website www.tigenix.com  or contact Gil Beyen, CEO, at info@tigenix.com or on + 32 (0)16 39 60 60.