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BioSyntech receives approval for Canadian BST-DermOn(R) pivotal clinical trial |
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25 Aug 2006 |
LAVAL, Canada | Aug 24, 2006 | BioSyntech Inc. (TSX-V: BSY) announced today that it has received approval from Health Canada, Therapeutic Products Directorate, Medical Devices Bureau, to begin enrolling subjects in its pivotal clinical trial for BST-DermOn®, a medical device designed to repair chronic wounds. Entitled “ A multicenter, prospective, randomized comparison study of BST-DermOn versus standard of care in the treatment of diabetic foot ulcers,” this trial is expected to provide data needed to support Canadian and European regulatory approvals of BST- DermOn® .
“The treatment of chronic wounds is a major drain on health systems worldwide, and despite a number of existing options, there remains a real need for a more effective solution," said Claude LeDuc, President and CEO of BioSyntech. “We believe that BST- DermOn® could be a first-line hydrogel treatment for this large market. The trial data will not only support Canadian and European approvals, but will be instrumental in confirming our regulatory strategy for the United States.”
BioSyntech has consulted with leading clinicians and regulatory and marketing experts to produce a strong scientific protocol design which addresses current clinical concerns as well as regulatory requirements. The BST-DermOn® trial will be used to treat chronic diabetic foot ulcers located on the mid or forefoot of 130 subjects between 18 and 80 years of age. Subjects with wounds varying from 1 to 10 cm2 will be randomized between BST-DermOn® and standard of care (65/group). The primary endpoint for this trial will be the percentage of closed wounds at 12 weeks, defined clinically as complete re-epithelialization. Secondary endpoints will be the reduction of wound size at 20 weeks, measured by computer planimetry of wound outlines, as well as safety.
Dr. Gary Sibbald, an internationally recognized leader in the field of dermatology and wound repair, has accepted the responsibility of Principal Investigator for this trial. Dr. Sibbald will recruit subjects at 2 sites: the WoundRepairCenter at Women’s College (Toronto, ON) and the Mississauga Dermatology Centre (Mississauga, ON). BioSyntech plans to open 10-15 sites in Canada, and is currently in the process of conducting site qualification and training visits. An Investigator’s Meeting is scheduled for late October, and subject enrolment will begin shortly thereafter.
As previously announced, critical study initiation steps, monitoring and reporting will be managed by MedQualis Inc., a Montreal-based contract research organization (CRO) which will ensure that the trial adheres to regulatory requirements and that the outcomes are accepted by regulatory agencies.
About BST-DermOn®
BST-DermOn is a first-line spread-on treatment for chronic wounds used in conjunction with a semi-occlusive secondary dressing. As a hydrogel, it provides a moist healing environment while simultaneously distributing chitosan over the wound surface, bringing chitosan’s unique blend of potential wound healing characteristics to the repair environment.
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 9001:2000 standards. For additional information, visit www.biosyntech.com .
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SOURCE: BioSyntech, Inc. |
