CO.DON - successful conclusion of Phase II trial “co.dis” demonstrates efficacy and safety of the EU-authorised pharmaceutical product Spherox

After five years of follow-up observation, CO.DON AG has brought the Phase II clinical trial “co.dis” to a successful close. In the long-term clinical study 75 patients aged between 18 and 50, with cartilage defects in the knee, were treated with the autologous matrix-associated chondrocyte transplants from CO.DON AG in various dosages.

The interim results collected annually over the four-year follow-up period confirm the lasting and significant improvement compared with the baseline. Therapeutic success was partly measured using the KOOS (Knee Injury and Osteoarthritis Outcome Score) and the MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scores. The KOOS score reflects the patient's own weighted 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 MRI images. Lasting improvements were determined in all the scores used, which shows that Spherox indicated to treat cartilage defects of the knee is also sustainably effective and long term safe. 

In early 2018 the year-five follow-up examination was carried out for the last patient, which was followed by final statistical analysis and evaluation.

CO.DON AG develops, produces and markets autologous cell therapies for the minimally-invasive repair of cartilage defects in the knee following traumatic or degenerative defects. Spherox is a cell therapy product that uses only the patient's own cartilage cells ("autologous chondrocytes"). The treatment has been used in over 200 clinics to treat more than 12,000 patients. In July 2017 the company received EU marketing authorisation for Spherox. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Ralf M. Jakobs.

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Matthias Meißner, M.A.

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