Leuven (BELGIUM) – June 8, 2010 – TiGenix NV (NYSE EURONEXT: TIG) announces
that the 5-year follow-up results of the ChondroCelect® TIG/ACT/01/2000 pivotal
clinical study will be presented this week at the 14th ESSKA Congress in Oslo,
Norway. The results confirm the durability of the therapeutic effect of ChondroCelect
and clearly illustrate that early treatment results in superior long-term clinical
outcomes.
In 2002, TiGenix initiated a multi-centre prospective randomized controlled trial to assess
ChondroCelect’s efficacy as a first-line treatment for symptomatic cartilage defects of the
knee, by comparison with a current treatment option, microfracture. One hundred and
twelve patients were treated in this randomized controlled study, which has shown that
ChondroCelect treatment results in significantly superior structural cartilage repair at one
year follow-up1 and better clinical outcome2 at three years as compared to microfracture.
Prof. Dr. Daniël Saris (University Medical Center Utrecht, The Netherlands), one of the lead
investigators of the study, will present the 5-year follow-up data of this study on Thursday,
June 10 at 17h40 at the 14th congress of the European Society of Sports Traumatology,
Knee Surgery and Arthroscopy (ESSKA) in Oslo, Norway. The study’s principal
investigator, Dr. Johan Vanlauwe (University Hospitals Leuven, Belgium), will also discuss
the new data in his presentation on long-term outcomes of autologous chondrocyte
implantation during a TiGenix satellite symposium on Friday, June 11, starting at 12h30.
The new follow-up data confirm that the therapeutic effect and the clinical benefit of
ChondroCelect are maintained up to at least five years after the cartilage repair intervention.
The data also confirm the benefit of early intervention in cartilage lesions. Early treatment
with ChondroCelect resulted in a superior clinical benefit over microfracture and a lower
failure rate. Conversely, patients who had experienced symptoms for five years or more
prior to treatment did not derive substantial long-term benefit from either treatment.
“The results from this controlled clinical study confirm what a growing number of experts in
the field had come to understand: it is necessary to treat patients with cartilage lesions as
soon as possible in order to derive the greatest clinical benefit.” says Prof. Dr. Daniël Saris:
“Several years after the damage and with progressive wear and tear, the knee joint and the
underlying bone may be too damaged for treatments to be effective. The environment in the
joint is disturbed and cell transplantation becomes less successful.”
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that
focuses on ‘Regenerating Motion’. The company is exploiting the power of Regenerative Medicine to
develop durable treatments, validated through controlled clinical trials, for damaged and diseased
skeletal tissues.
TiGenix is developing a portfolio of products that address specific musculoskeletal problems. The
lead indication among these is cartilage damage, which is a debilitating affliction affecting the mobility
and functioning of patients. Western societies are characterised by ageing populations that place an
increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems
represent a large and growing unmet medical need. Current therapies do not provide satisfying, longterm
durable repair and TiGenix therefore believes there is a need for more effective treatments for
cartilage damage.
About ChondroCelect®
ChondroCelect®, the company’s lead product for cartilage regeneration in the knee, is an
implantation suspension of characterised viable autologous cartilage cells expanded in vivo and
expressing specific marker proteins. The product is administered to patients in an autologous
chondrocyte implantation procedure (ACI), a surgical procedure to treat cartilage defects, in
conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement
of a biological membrane, preferentially a collagen membrane) and rehabilitation.
ChondroCelect is indicated for the repair of single symptomatic cartilage defects of the femoral
condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults with or
without concomitant asymptomatic cartilage lesions (ICRS grade I or II).
Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of
ChondroCelect in patients with lesions between 1-5 cm2. In the randomised controlled trial, the most
common adverse reactions were arthralgia (47.1%), cartilage hypertrophy (27.4%), joint crepitation
(17.6%) and joint swelling (13.7%). Most of the reported adverse reactions were expected as related
to the open-knee surgical procedure. The most frequently occurring reactions reported immediately
after surgery include joint swelling, arthralgia and pyrexia. These were generally mild and
disappeared in the weeks following surgery. Cartilage hypertrophy occurred only at a rate of 1.8% in
the 370-patient Compassionate Use Program, where a collagen membrane instead of a periosteal
flap was used to seal the defect. Please consult full prescribing information (www.emea.eu) for
details on appropriate use and safety information.
ChondroCelect is the first cell-based product that successfully completed the entire development
track from research, over clinical development to central European registration as a medicinal
product. On October 5, 2009 ChondroCelect received European marketing authorisation as the first
approved Advanced Therapy Medicinal Product (ATMP).
Forward-looking information
This document contains forward-looking statements and estimates with respect to the anticipated
future performance of TiGenix and the market in which it operates. Certain of these statements,
forecasts and estimates can be recognised by the use of words such as, without limitation,
“believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue”
and similar expressions. They include all matters that are not historical facts. Such statements,
forecasts and estimates are based on various assumptions and assessments of known and unknown
risks, uncertainties and other factors, which were deemed reasonable when made but may or may
not prove to be correct. Actual events are difficult to predict and may depend upon factors that are
beyond the Company's control. Therefore, actual results, the financial condition, performance or
achievements of TiGenix, or industry results, may turn out to be materially different from any future
results, performance or achievements expressed or implied by such statements, forecasts and
estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of
such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements,
forecasts and estimates only speak as of the date of the publication of this document. TiGenix
disclaims any obligation to update any such forward-looking statement, forecast or estimates to
reflect any change in the Company’s expectations with regard thereto, or any change in events,
conditions or circumstances on which any such statement, forecast or estimate is based, except to
the extent required by Belgian law.
