VitroGro gets topical

Canadian regulators have agreed to classify Australian biotech Tissue Therapies' VitroGro as a topical biologic rather than a pharmaceutical, allowing it to fast-track its clinical testing.

VitroGro is a platform technology developed by tissue engineering experts at the Institute for Health and Biomedical Innovation at QUT for enhancing cell growth and migration.

It has particular commercial applications in wound healing, tissue regeneration, stem cell therapies and other cell culture uses.

Tissue Therapies' CEO, Dr Steven Mercer, said the classification of VitroGro as a topical biologic meant the clinical regulatory requirements for product assessment would be similar to those required for approval of a medical device, rather than a pharmaceutical.

He said the regulatory testing required to bring the products to market would be considerably faster than those required for a pharmaceutical.

"This is an exciting milestone for the commercialisation of VitroGro-based clinical products for wound care and other applications, and a major milestone in the final preparations for the clinical trial scheduled for completion in December 2007," he said.

"The Canadian classification, together with the upcoming clinical trial data, will also provide the opportunity to access the markets of Canada, EU, Switzerland, Australia, New Zealand and Asia, as well as potentially accelerating access into the United States."

He said the company was currently in discussions with providers in Canada to undertake the required tests and was very confident that these will be accommodated within the clinical trial timetable

Tissue Therapeutics recently signed a worldwide sales and distribution agreement with Invitrogen and also has a joint development agreement with Novozymes.