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BioSyntech, Inc. today announced it has received positive preliminary results from a prospectively planned six-month interim analysis of its Canadian-European pivotal clinical trial for BST-CarGel(R)
LAVAL, Quebec | March 17, 2008 | BioSyntech, Inc. (“BioSyntech” or “the Company”) (TSX: BSY), a biotechnology company developing novel products in regenerative medicine, today announced it has received positive preliminary results from a prospectively planned six-month interim analysis of its Canadian-European pivotal clinical trial for BST-CarGel®. Results drawn from a 20 subject subset of the trial indicate evidence of a positive effect of BST-CarGel®treatment on cartilage structure when compared to the surgical control. The interim analysis also showed the safety of BST-CarGel® to be comparable to the control. The sole purpose of this interim analysis was to obtain pilot data for submission to the U.S. Food and Drug Administration (FDA) as a pilot study in support of an Investigational Device Exemption (IDE) for a U.S. pivotal trial for this medical device.
Dr. William Stanish, Professor of Surgery at Dalhousie University in Halifax, Nova Scotia, and Principal Investigator for the trial commented, "I do not have access to interim analysis data, but it came as no surprise when BioSyntech told me that the evidence for BST-CarGel® appears to be positive. The fundamental science behind the product is strong and is what led me to participate in this initiative." Dr. Stanish treated several of the subjects included in the interim analysis.
“Evidence of a positive effect of BST-CarGel®on both the quantity and quality of the regenerated cartilage tissue is important at this six month interim point, since these parameters comprise the primary endpoints of the study,” said Claude LeDuc, CEO of BioSyntech, “These results are in line with our published animal studies demonstrating similar positive outcomes, as well as anecdotal data in humans treated under Health Canada’s Special Access Program. Furthermore, this data supports our belief that BST-CarGel® could be a cost-effective, off-the-shelf surgical alternative that could dramatically improve cartilage repair over traditional methods in a minimally invasive manner. We expect to confirm safety and efficacy of BST-CarGel® in the longer 12 month analysis of the entire sample population of 80 subjects.”
About the Canadian-European BST-CarGel® trial
The ongoing BST-CarGel® clinical trial is a randomized, comparative study of the treatment of focal cartilage lesions located on the medial femoral condyle in 80 subjects (40/group) from 18 to 55 years of age. Treatment with BST-CarGel® applied to a microfractured cartilage lesion under 10 cm2, is being compared to microfracture alone applied to similar lesions. Subjects are randomized to treatment by either BST-CarGel® or microfracture, and further stratified to 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 through the quantity and quality of the repair tissue measured with quantitative magnetic resonance imaging (MRI). Secondary endpoints are safety and knee-related pain, stiffness and function measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire.
Subject enrolment currently stands at over 50% for this pivotal trial and extensive efforts are underway to complete enrolment in 2008.
About BioSyntech
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®, 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. The Company’s two lead, late-stage products, BST-CarGel® and BST-DermOn™, are currently undergoing Canadian and European pivotal trials. For additional information, visit www.biosyntech.com.
Forward-Looking Statements
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.
Readers should not place undue reliance on the forward-looking information, given that (i) our actual results could differ materially from a conclusion, forecast or projection in the forward-looking information, and (ii) certain material factors or assumptions which were applied in drawing a conclusion or making a forecast or projection as reflected in the forward-looking information, could prove to be inaccurate. Additional information about (i) the material factors that could cause actual results to differ materially from the conclusion, forecast or projection in the forward-looking information, and (ii) the material factors or assumptions that were applied in drawing a conclusion or making a forecast or projection as reflected in the forward-looking information, is contained in the Company’s annual report and other documents filed from time to time with the Canadian securities commissions which are available at www.sedar.com. These statements speak only as of the date they are made, and we assume no obligation to revise such statements as a result of any event, circumstance or otherwise, except in accordance with law.
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SOURCE: BioSyntech, Inc. |
