co.don Aktiengesellschaft: further positive three-year data of the Phase II trial 'co.dis'
co.don AG: further positive three-year data of the Phase II trial "co.dis"
+ Interim results provides evidence of the product's safety profile and significant improvements to patient well-being
Berlin / Teltow, 22 November 2016 - co.don AG has received further interim results from the Phase II clinical trial "co.dis", which demonstrate the safety and therapeutic benefits three years after treatment.
In the long-term clinical study 75 patients aged between 18 and 50, with cartilage defects in the knee of 4 to 10 cm2, were treated with the autologous matrix-associated chondrocyte implants co.don condrosphere(R) in various dosages.
Results of the KOOS and MOCART scores have now been analysed three years after treatment. The KOOS score is a subjective metric that reflects the patient's own assessment of categories including: Knee-related statement on quality of life, knee function in sport and leisure and pain. The MOCART score shows the clinical success of the treatment using MRT images.
The results confirm the lasting and significant improvement compared with the status quo before treatment.
In particular, the therapy is also effective for defects which are comparatively difficult to treat. So cartilage defects on the back of the kneecap were treated with above-average success.
Currently co.don AG is conducting another multi-centric, prospective, randomised open-label Phase III trial in line with the internationally acknowledged Good Clinical Practice (GCP) standards, which has also been in the follow-up observation period since December 2014.
These trial data strongly support co.don to meet regulatory requirements of the European Medicines Agency (EMA) to obtain EU marketing authorisation. The company anticipates EU market approval in the fourth quarter 2017. Co.don has held sales approval for the German market for many years.
Dirk Hessel, CEO of co.don AG said: "Receiving marketing authorisation in the European Union in addition to the German market will open up enormous potential for us. In order to exploit this potential, we are working to prepare the European product launch. Now these interim results of the trial encourage us to pursue these efforts with all our strength."
About co.don AG: Berlin-based co.don AG develops, produces and markets in Germany autologous cell therapies for the minimally invasive repair of cartilage damage to joints following traumatic or degenerative defects. co.don condrosphere(R) is a cell therapy product that uses only the patient's own cartilage cells ("autologous chondrocytes"). co.don condrosphere(R) has been approved by the German federal agency PEI in accordance with Section 4b of the German Pharmaceuticals Act (AMG) and is currently undergoing Phase II and III clinical trials to obtain European marketing authorisation. co.don condrosphere(R) has been used for more than 10 years in over 120 clinics to treat more than 10,000 patients. In Germany the statutory health insurance companies have paid for the treatment of knee and hip joints since 2007 and for the treatment of vertebral joints since 2008. The shares in co.don AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Dirk Hessel (CEO), Ralf M. Jakobs (CFO). Further information can be found at www.ihre-zellzuechter.de or www.codon.de
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Language: English Company: co.don Aktiengesellschaft Warthestraße 21 14513 Teltow Germany Phone: 03328 43460 Fax: 03328 434643 E-mail: email@example.com Internet: www.codon.de ISIN: DE000A1K0227 WKN: A1K022 Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Stuttgart, Tradegate Exchange End of News DGAP News Service