BioSyntech Receives Approval for Canadian BST-Cargel'R' Pivotal Clinical Trial.LAVAL, Quebec -- BioSyntech, Inc. ("BioSyntech" or "the Company") (TSX VENTURE:BSY) announced today that it has received approval from Health Canada, Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. , Medical Devices Bureau, to begin its pivotal clinical trial for BST-CarGel(R). The Company expects the data from this trial to support Canadian and European regulatory approval of BST-CarGel(R), a medical device for cartilage repair designed to regenerate cartilage in a process called In Situ ChondroInduction (ICI (language) ICI - An extensible, interpretated language by Tim Long with syntax similar to C. ICI adds high-level garbage-collected associative data structures, exception handling, sets, regular expressions, and dynamic arrays. ). Subject enrolment and surgery will commence immediately and treatment will proceed according to surgical facility availability. "Historically, treatment of cartilage damage has been a problematic area for orthopaedics due to a continued lack of technological breakthroughs. This has left many patients without viable options, and many of these patients may eventually require total knee replacement," said Mr. Claude LeDuc, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of BioSyntech. "We believe that BST-CarGel(R) is a potential solution to this growing need to repair cartilage damage and, to that end, have initiated a controlled and randomized clinical trial randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. with a strong scientific design. Our trial data will not only support Canadian and European approval, but may be instrumental in gaining regulatory approval in the United States." The BST-CarGel(R) trial will be a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , comparative study of the treatment of focal cartilage lesions located on the medial femoral femoral /fem·o·ral/ (fem´or-al) pertaining to the femur or to the thigh. fem·o·ral adj. Of or relating to the femur or thigh. condyle condyle /con·dyle/ (kon´dil) a rounded projection on a bone, usually for articulation with another bone.con´dylar con·dyle n. in 80 subjects from 18 to 50 years of age. Treatment with BST-CarGel(R) applied to a microfractured cartilage lesion varying from 4 to 10 cm2 will be compared to microfracture alone applied to similar lesions. Subjects will be randomized between the BST-CarGel(R) group and the microfracture group, and further stratified stratified /strat·i·fied/ (strat´i-fid) formed or arranged in layers. strat·i·fied adj. Arranged in the form of layers or strata. to their lesion type, either characterized as acute (i.e. traumatic) or chronic (i.e. degenerative). Following surgery, all subjects will follow the same 12 week physiotherapy regimen, which utilizes assisted passive motion and common strengthening exercises, and calls for a 6 week period of non-weightbearing. The primary endpoint for this trial will be cartilage repair at 12 months, defined as a composite of the quantity and quality of the repair tissue measured through validated, advanced magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. ). Other major endpoints at 12 months include knee-related pain, stiffness and function, as well as overall quality of life assessed through subject-filled questionnaires. For the MRI component of this trial, the Company has retained Rochester, NY-based VirtualScopics, LLC, the premier provider of innovative imaging solutions utilizing biomarkers for product development and clinical trials. VirtualScopics has extensive clinical experience in musculoskeletal radiology using patented analytical techniques which detect, measure and analyze specific biological structures from MR imaging. This expertise coincides well with this trial's cartilage repair objective. These scans, which include both screening of potential subjects as well as 12 month endpoint assessments, will be carried out at one pre-qualified MRI clinic at each site, followed by blinded data analysis at VirtualScopics. As previously announced, critical study initiation steps, monitoring and reporting will be managed by Cato Research Ltd., a contract research organization (CRO) who will ensure that the protocol and the study conduct adhere to regulatory requirements to ensure that the outcomes are accepted by regulatory agencies. Sites involved in this trial are located in Winnipeg, Halifax, Calgary, Montreal and Toronto. BioSyntech will add sites, if needed, according to enrolment rates. About BST-CarGel(R) BST-CarGel(R) is a promising new therapeutic approach for repair of localized cartilage lesions. Applied during minimally-invasive surgery, it acts in situ as a 3-dimensional scaffold and may guide the repair of the damaged cartilage. About BioSyntech BioSyntech is a biotechnology company specializing in the discovery, development and manufacturing of innovative cost-effective and physician-friendly therapeutic thermogels for regenerative medicine and therapeutic delivery. BioSyntech's Quality Management System is registered to ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001:2000 standards. For additional information, visit www.biosyntech.com. NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS RELEASE. THE TSX VENTURE EXCHANGE TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. BioSyntech Inc. (TSX VENTURE:BSY) |
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion