co.don AG reaches next milestone on the way to central authorisation
Recruitment phase for Phase II clinical trial successfully completed
Teltow. co.don AG has successfully concluded the recruitment phase of its Phase II clinical trial. In the long-term clinical trial (Trial No. cod 16 HS 14), 75 patients with cartilage defects of 4-10 cm2 in their knee joints were treated with co.don chondrosphere®, an autologous, matrix-associated chondrocyte transplant.
"With these new clinical trials we are in compliance with the changes in the regulatory standards applied by the European Medicines Agency (EMA). The aim is to obtain European marketing authorisation from the EMA" explained Dr Andreas Baltrusch, CEO of co.don AG. co.don AG is currently carrying out two multi-centric, prospective and randomised open-label trials in accordance with the internationally acknowledged standard Good Clinical Practice (GCP). Throughout Germany, 12 centres, including three university clinics, are taking part in the trials.
co.don chondrosphere® is used to treat cartilage defects in knee, ankle, shoulder, elbow and hip joints. The three-dimensional chondrocyte transplants are cultivated by co.don AG in special laboratories exclusively from the patient's own cells. More than 4,500 patients have been treated with co.don AG's patented, regenerative procedure to date.
By healing the damaged cartilage or repairing the cartilage defect it is often possible to obviate the need for a subsequent prosthesis. Another advantage for the patient is the minimally invasive and gentle operation, as orthopaedic surgeons mostly perform the chondrocyte transplantation arthroscopically.
About co.don® AG:
The company is based in Teltow, Brandenburg, and was founded in 1993. Since 2001 the biopharmaceutical specialist has been listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). co.don AG® uses tissue engineering - the cultivation and growth of autologous tissue cells - to develop innovative products and therapeutic concepts for the orthopaedic and neurosurgical markets. The cell-based biological drugs (autologous cell transplants for articular cartilage and intervertebral disks) are produced without the use of antibiotics, growth factors and genetic engineering. The Executive Board of co.don® AG is made up of Dr Andreas Baltrusch (CEO) and Vilma Siodla (COO).
Further information is also available from: www.codon.de
|Gerd J. Gauger|
|Bonner Straße 328|
|Telephone:||+49 221 348 038 10|
|Fax:||+49 221348 038 41|