Positive 5-year ChondroCelect follow-up results to be presented at ESSKA
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.'
'It is encouraging to see that the clinical benefit which was gained at 18 to 24 months, was maintained throughout the five-year period following treatment.' says Dr. Johan Vanlauwe: 'It establishes cartilage regeneration using ChondroCelect as a credible solution to achieve meaningful long-term clinical outcomes'.
For more information, please contact:
Gil Beyen
Chief Executive Officer
Koenraad Blot
Chief Medical Officer
Kris Motmans
Corporate Communications
Tel: +32 16 39 60 60
E-mail: investor@tigenix.com
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.
_________________________________________________
1 'Characterized chondrocyte implantation results in better structural repair when treating symptomatic cartilage
defects of the knee in a randomized controlled trial versus microfracture' by D. Saris, J. Vanlauwe et al. AJSM,
Vol. 36, No. 2, pp. 235-246 (February 2008)
2 'Treatment of Symptomatic Cartilage Defects of the Knee: Characterized Chondrocyte Implantation Results in
Better Clinical Outcome at 36 Months in a Randomized Trial Compared to Microfracture' by D. Saris, J.
Vanlauwe et al. AJSM, Vol. 37 - Supplement 1, pp. 10S-19S (November 2009)
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.'
'It is encouraging to see that the clinical benefit which was gained at 18 to 24 months, was maintained throughout the five-year period following treatment.' says Dr. Johan Vanlauwe: 'It establishes cartilage regeneration using ChondroCelect as a credible solution to achieve meaningful long-term clinical outcomes'.
For more information, please contact:
Gil Beyen
Chief Executive Officer
Koenraad Blot
Chief Medical Officer
Kris Motmans
Corporate Communications
Tel: +32 16 39 60 60
E-mail: investor@tigenix.com
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.
_________________________________________________
1 'Characterized chondrocyte implantation results in better structural repair when treating symptomatic cartilage
defects of the knee in a randomized controlled trial versus microfracture' by D. Saris, J. Vanlauwe et al. AJSM,
Vol. 36, No. 2, pp. 235-246 (February 2008)
2 'Treatment of Symptomatic Cartilage Defects of the Knee: Characterized Chondrocyte Implantation Results in
Better Clinical Outcome at 36 Months in a Randomized Trial Compared to Microfracture' by D. Saris, J.
Vanlauwe et al. AJSM, Vol. 37 - Supplement 1, pp. 10S-19S (November 2009)
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