LAVAL, QC, June 17 /PRNewswire-FirstCall/ - BioSyntech, Inc. (TSX: BSY), a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced statistically significant results from an analysis of patients who completed their 12 month follow-up in the BST-CarGel(R) randomized clinical trial. Specifically, statistically significant evidence of improved repair tissue quality due to BST-CarGel treatment was found during analyses of tissues biopsied from the knees of 22 patients. The ongoing multicenter pivotal trial is evaluating the ability of BST-CarGel to repair cartilage lesions in the knee when applied to a microfractured lesion compared to microfracture alone (control) in 80 patients. Final results on all 80 patients are expected in the first half of 2010.
"We are excited by these positive results, which will be highly supportive in our ongoing discussions with potential orthopedic partners. Although we have not yet completed all facets of this Interim Analysis, we felt obligated to disclose these first histology results as biopsy data is considered the gold standard for assessment of cartilage repair," said Mr. Michel Lagueux, Chairman of the Board.
Using histological methods (i.e. analyses by microscope) to process and analyze the biopsied tissues from 13 BST-CarGel patients and 9 microfracture patients, and using third parties to perform the statistical analysis, statistically significant improvements were identified for critical tissue characteristics following BST-CarGel treatment compared to microfracture alone. In particular, after applying the International Cartilage Repair Society's (ICRS) histological scoring systems I and II to the biopsies in a blinded manner, several parameters were found to be statistically significant between treatment groups at p(less than)0.05. First, the Overall ICRS II score was significantly better for the BST-CarGel group than for the microfracture group (p=0.045), with scores of 64.5 and 36.9 respectively. Considered to be the most important parameter within the ICRS II scoring system, the ICRS II Overall score assimilates all the parameters listed in the grading system to generate an overall assessment of tissue repair. Other statistically significant improvements were found in the assessments of Cell Morphology, Cell Viability and Superficial Zone morphology in the biopsies. Furthermore, Surface Architecture, collagen structure as observed by Polarized Light Microscopy, and repair tissue thickness measurements demonstrated improvement in favour of BST-CarGel. Macroscopic grading of the cartilage repair by the surgeon at the time of biopsy, which included the extent of lesion filling, tissue surface characteristics and integration with surrounding tissue, was also significant (p=0.016).
Dr. Kenneth Zaslav, an orthopaedic Key Opinion Leader from Richmond Virginia, was one of three independent experts who reviewed the data. He commented, "This randomized controlled study performed under good clinical practice guidelines is a well run study with robust data that will have an impact on scaffold directed cartilage repair in the coming years. I congratulate the Company on this early stage histological data and the rigor of the study design."
Dr. Matthew Shive, Chief Scientific Officer, added, "These compelling findings, particularly their statistical significance, provide a clear indication as to the positive effect of BST-CarGel in the treatment of cartilage lesions in the knee compared to the standard of care and affirm the value of BST-CarGel as a unique, single-stage product that has the potential to dramatically improve the outcome of cartilage repair procedures."
Analysis of other data for the primary endpoint of the trial, cartilage repair at 12 months, will be defined by the quantity and quality of the repaired tissue as measured by quantitative magnetic resonance imaging (MRI), and is still ongoing for the Interim Analysis. Secondary endpoints of safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire are also being compiled for the Interim Analysis. All of this end point data and analysis continues to form part of the ongoing Interim Analysis and results are expected in the next few months.
About the Canadian-European BST-CarGel trial
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 patients aged 18 to 55 years of age with focal cartilage lesions less than 10 cm(2) located on the femoral condyles of the knee. Patients 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. A previous interim analysis demonstrated the safety of BST-CarGel to be comparable to the Microfracture control on the first 23 patients at 6 months.
BioSyntech is a medical device company specialized in the development, manufacturing and commercialization of advanced biotherapeutic thermogels for regenerative medicine (tissue repair) and therapeutic delivery. BioSyntech's platform technology is a family of hydrogels called BST-Gel(R), some of which are liquid at low temperature and solid at human body temperature. These gels can be injected or applied to a specific local site and offer beneficial properties for the local repair of damaged tissue such as cartilage, bone and chronic wounds and provide the benefit of avoiding invasive surgery. For additional information, visit www.biosyntech.com.
This press release contains forward-looking statements and information which are subject to material risks and uncertainties. Such statements are not historical facts and are based on the current expectations of management. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking information. These risks include, but are not limited to, those associated with our capacity to finance our activities, the adequacy, timing, and results of our clinical trials, the regulatory approval process, competition, securing and maintaining corporate alliances, market acceptance of the Company's products, the availability of government and insurance reimbursements for the Company's products, the strength of intellectual property, the success of research and development programs, reliance on subcontractors and key personnel, and other risks and uncertainties detailed from time-to-time in our filings with the Canadian securities commissions.
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|SOURCE BioSyntech, Inc.|
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