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TISSUE THERAPIES TO START PERTH TRIAL

July 13th 2008 00:01
Wednesday July 9, 2008

Daily news on ASX-listed biotechnology companies

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TISSUE THERAPIES

Tissue Therapies expects to begin a Vitrogro clinical trial for venous ulcers in Perth in August 2008.

The company has been attempting to start a separate trial in Toronto but regulatory hurdles have delayed that trial by more than six months.

Tissue Therapies’ chief executive Dr Steven Mercer said the Perth trial would complement the Toronto trial.

Dr Mercer said approval for the Perth trial followed agreement between Tissue Therapies’ chief clinical investigators, Prof Michael Stacey from the University of Western Australia and Prof Gary Sibbald, who is the director of dermatology and wound healing at the Womens’ College Hospital in Toronto.

“The human trial of Vitrogro at Prof Stacey’s wound care centre in Perth will focus on the treatment of venous ulcers, while the Toronto study will also include diabetic and pressure ulcers,” Dr Mercer said.

“The Perth trial will start after a short period of patient recruitment,” Dr Mercer said.

“Interim results will be released progressively and final results are expected in early 2009, within six months of first patient treatment,” he said.

Dr Mercer said preparation for both trials was complete and the Toronto trial would commence as soon as final approval was granted.

He said Tissue Therapies had responded to technical queries from Health Canada as part of the regulatory approval process and the company was “keenly awaiting the response from Health Canada”.

Dr Mercer said that the two trials were highly complementary and that data from both trials would be used to validate the performance of the Vitrogro wound care process.

Tissue Therapies said Vitrogro was a synthetic, animal product-free technology delivering growth-enhancing factors to cells, tissue and patients, based on the protein vitronectin.

“The Canadian clinical trial monitor Dr Douglas Queen will review the data from both studies and these results will be used in ongoing commercial negotiations with the international wound and healthcare companies that have expressed commercial interest in Vitrogro,” Dr Mercer said.

“A number of major wound care and healthcare companies have expressed commercial interest in Vitrogro and are now awaiting initial clinical trial results,” he said.

Dr Mercer said Tissue Therapies had the scientific and preclinical evidence that Vitrogro would be a transforming technology in a wound care market estimated at $US4 billion.

“We have great confidence in the clinical results of Vitrogro based on more than six years of research using live human skin cells in the laboratory,” Dr Mercer said.

“The scientific development and refinement of Vitrogro has provided a potentially fast and cost-effective cure for diabetic, venous and pressure ulcers,” Dr Mercer said.

“This would relieve the clinical, personal, emotional, economic and social devastation of a pandemic that is currently causing an amputation every 30 seconds,” Dr Mercer said.

Tissue Therapies said that among its other benefits, the approval of the Perth-based clinical trial allowed “improved certainty” for Tissue Therapies’ commercial planning purposes.

Tissue Therapies said it would consider further fund-raising options for large scale manufacturing of new formulation Vitrogro to maximize sales and enhance margins and to provide additional working capital and fund product development.

Tissue Therapies climbed 1.7 cents or 17.35 percent to 11.5 cents.


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