The human trial of VitroGro will be conducted by Dr Gary Sibbald, a wound care expert of international standing, and the Study Monitor will be Dr Douglas Queen, a scientist and world expert in the investigation and commercialisation of new wound care technologies. The CEO of Tissue Therapies, Dr Steven Mercer said, "We are delighted with the Ethics approval for what will be a pivotal human study for the commercial development of wound healing products containing VitroGro. Drs Sibbald and Queen have previously conducted many human wound care product trials for major international North American and European health care companies and their experience and expertise and that of their teams are of great value to Tissue Therapies."
Dr Queen has extensive experience as a senior executive in the wound care industry and more recently as a Clinical Trial Monitor and consultant to the wound care industry. Dr Queen is excited about the potential for VitroGro to fundamentally change the treatment of chronic skin ulcers. He commented, "VitroGro has the potential to become the default dressing technology for wound care worldwide, a market conservatively valued at more than USD$4Bn this year."
Dr Mercer added, "Given that Tissue Therapies has successful data from preclinical testing with live human skin cells and a three dimensional live human skin model for more than five ears, I have great confidence that the clinical trial results will demonstrate that VitroGro is a successful ulcer treatment."
"I am convinced that we can make a substantial difference to the treatment of diabetic, venous and pressure ulcers with a unique, new, cost effective dressing technology." The human trials will be conducted at the Dr Gary Sibbald Toronto Wound Healing Centres in Toronto, Canada.
The Trafalgar Ethics Board approval follows the notification during January 2008 from Health Canada that the formal regulatory classification of VitroGro is a Class IV Medical Device, not as a pharmaceutical or a lower Class Device. This Class IV Device classification has the commercial benefits of avoiding the costs and time of a pharmaceutical clinical trial and regulatory approval, while allowing Tissue Therapies to make specific claims about the ability of VitroGro to accelerate wound healing. This will also allow sales and distribution by traditional devices/wound care companies instead of limiting sales of VitroGro products only through pharmaceutical companies.
About Factor Therapeutics Ltd
Factor Therapeutics Limited, formerly Tissue Therapies Limited, is a biotechnology company. The Company's principal activities include the development and commercialization of its intellectual property in wound care.
Factor Therapeutics Ltd