BioSyntech announces start of patient recruitment into BST-DermOn(TM) pivotal clinical trial
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- Published on Friday, 09 February 2007 02:00
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LAVAL, Canada | Feb 08, 2007 | BioSyntech Inc. (TSX: BSY) announced today the start of recruitment into its Canadian pivotal clinical trial for BST-DermOn(TM), a medical device designed to repair chronic wounds and based on the natural polysaccharide chitosan. Dr. Gary Sibbald, an internationally recognized leader in the field of dermatology and wound repair, is the Principal Investigator for this trial.
"This represents another positive milestone for our company because
BST-DermOn(TM) is the second BioSyntech product to reach the critical clinical trial stage. The successful development of this new treatment will help position BioSyntech as an innovative leader in the area of wound healing," said Claude LeDuc, President and CEO of BioSyntech. "Furthermore, we are very pleased with the participation of Dr. Sibbald as Principal Investigator because it underscores the potential of BST-DermOn(TM) in treating diabetic foot ulcers as the first of several indications, including other chronic and acute wounds".
Approximately 3.7 million people suffer from chronic wounds in the United States. Of that, about 1 million are identified as diabetic ulcers, a major complication of diabetes.
The Principal Investigator, Dr. Sibbald, is the Director of the Wound Healing Clinic and Director of Medical Education at the Women's College Hospital in Toronto, Ontario. He was a founding board member of theAssociation for Advancement of Wound Care in the United States and a co-founder and past chairman of the Canadian Association of Wound Care. "I am very pleased to act as the Principal Investigator for this well-designed and comprehensive pivotal clinical trial" said Dr. Sibbald. "I have long been aware of chitosan and its potential role in wound healing, and as such, I believe that BST-DermOn(TM) holds great promise for treating wounds that are difficult to heal".
This prospective, multi-center, randomized, controlled study will enrol 130 type 1 or type 2 diabetic subjects with a diabetic foot ulcer on the mid or forefoot. Enrolled subjects will receive either the standard of care or BST-DermOn(TM). Treatments in both groups will be applied 3 times a week for up to 20 consecutive weeks or until the ulcer is closed. The primary endpoint will be the percentage of subjects with closed wounds at week 12. Secondary study endpoints include the reduction of wound size at week 20, safety, and the reduction in clinical signs of infection. The study will be conducted at 15 clinical sites across Canada in the provinces of Quebec, Ontario, Nova Scotia, New Foundland and Manitoba.
BST-DermOn(TM) 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. The inherent wound healing, haemostatic as well as bacteriostatic properties of the chitosan component of BST-DermOn(TM) have been well documented in the scientific literature.
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.
This press release contains forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable Canadian securities laws, which reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise.
For further information: BioSyntech, Inc., Yvonne Kramer Ph.D., Sen. Director Corporate & Business Development, (450) 686-2437, ext. 315,
SOURCE: BioSyntech, Inc.