BioSyntech, Inc., a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced that it will conduct an interim analysis of the available clinical data from 40 subjects who have completed their 12 month follow-up in the 80 subject trial for its cartilage repair device, BST-CarGel®. The Company expects to have the results from this analysis available in the second quarter of 2009.
“BioSyntech is in a situation where we can gain much earlier access to quality 12 month outcome data that will be of significant interest to potential orthopaedic partners, investors and stakeholders. This is a full interim analysis of safety and effectiveness derived from 40 subjects after a 12 month follow-up, which represents half of the study population and should provide a good indication as to the effect of BST-CarGel®in thetreatment of cartilage lesions in the knee compared to the standard of care,” said Michel Lagueux, Chairman of the Board of Directors. ”To ensure the integrity of the study, the data will be handled, analyzed and reported by third parties whom will remain blinded throughout the process along with our Clinical Investigators. It is our plan to complete the trial and carry out the final clinical analysis on the 80 subjects to maintain the scientific validity of the trial. The final clinical results should be available in the first half of 2010.”
The ongoing, randomized BST-CarGel® pivotal trial compares the treatment of cartilage lesions using BST-CarGel® applied following microfracture to treatment with microfracture alone as a control. The trial enrolled 80 subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm2 located on the femoral condyles of the knee. Subjects were further stratified by their lesion type, either characterized as acute (i.e. traumatic) or chronic (i.e. degenerative). The primary endpoint for this trial is cartilage repair at 12 months, defined by the quantity and quality of the repaired tissue as measured with quantitative magnetic resonance imaging (MRI). Secondary endpoints are safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. Results from this study are intended to support marketing applications in Canada and Europe. Final results of the trial are anticipated in the first half of 2010.