ASX-listed Tissue Therapies was incorporated in 2002 to commercialize Tissue Culture and Repair technology from the Queensland University of Technology (QUT) in Brisbane. The company develops biomedical technologies for wound healing, tissue and various cell culture applications.

Tissue Therapies’ unique wound care treatment technology VitroGro was developed by tissue engineering experts at the Institute for Health and Biomedical Innovation, QUT. VitroGro, which enhances cell growth and migration, has commercial applications in wound healing, tissue regeneration, stem cell therapies and other cell culture uses. In an e-mail interview with BioSpectrum, Dr Steven Mercer, CEO, Tissue Therapies, talks about the company’s plans to develop and commercialize the VitroGro platform as a prime choice in wound care treatment.

Can you elaborate on the applications and key benefits of VitroGro?
VitroGro has been designed to provide simple, effective and affordable new treatment for diabetic, venous and pressure ulcers. The objective of Tissue Therapies is to make VitroGro the default wound care treatment technology for the above-mentioned ulcers as well as for burns and acute wounds. We want to make it available in specialist units, general hospital units, general medicine, pharmacy and retail use.

While it has the potential for new wound healing treatments, it is also more cost effective than existing treatments. One of the key benefits of VitroGro is it allows creation of live human skin in the laboratory. It also produces more immunotherapy (anticancer) cells than commercially available cell growth media.

Another prime benefit is that it retains the wound healing activity after gamma irradiation. This is important for quick, cheap incorporation into wound dressings that are routinely sterilized with gamma irradiation at end of manufacture.

For this product some great results are being reported from various clinical trials. Can you give an update on the status of the trials VitroGro has been undergoing in different countries?
In Australia, a successful, eight-patient, human trial of VitroGro for the treatment of venous ulcers has been completed in Vascular Research Laboratory, Fremantle. In the trial it was found that the median wound area was reduced from 9.5 to 5.2 square centimeters in 24 days.

Since this was a short trial, complete ulcer healing was not a formal data point for collection but it was noted that the ulcers of the first two patients were completely healed after the end of the study. This is in comparison to commonly quoted statistics in the scientific and clinical literature which state that up to 50 percent of chronic skin ulcers will remain unhealed after 20 weeks of treatment.

In Canada, the clinical trial of VitroGro has started in Toronto at the wound care clinic run by the internationally known wound care expert Prof Gary Sibbald. A 29 percent reduction in the size of a chronic diabetic ulcer was achieved in six weeks for the first patient recruited into the trial. This is when conventional treatment for more than two years had produced no effect.

This patient, a 73-year-old man with diabetes and high blood pressure, presented an extremely challenging combination of complicating clinical factors. His diabetic ulcer at the base of his right big toe had been the site of recurrent infections. The patient was so despondent that he was considering amputation. This patient in many ways represents the most difficult and ambitious type for VitroGro’s clinical trial.

How many patents has the product got and in what geographies?
A total of five VitroGro patents are going through the examination process worldwide.

Tissue Therapies has lodged patent applications in Australia, Canada, US, Europe, New Zealand, South Korea, China, Hong Kong, India, Japan and South Africa. Patents have already been granted in the US, Australia, New Zealand and South Africa. These patents encompass the commercially important areas of VitroGro composition, use and antagonist action.

Applications for registration of the VitroGro trademark have also been made in the same territories.

Is the company in talks with potential partners for commercialization? What kind of penetration are you planning for APAC region?
Completion of the Canadian human clinical trial of VitroGro is anticipated within six months of commencement. With combined positive human clinical trial results from both the Australian and Canadian studies, Tissue Therapies will proceed with formal commercial partnership negotiations with identified potential healthcare partners.

Our strategy is to use positive human clinical trial results to leverage interest from international wound and healthcare companies to negotiate a strategic partnership agreement for the international sale and distribution of new VitroGro wound healing products.

Tissue Therapies is in discussion with a number of international wound and healthcare companies who have a commercial interest in VitroGro and have asked to be kept updated on clinical trial results. Candidate strategic partner companies have indicated they are waiting for clinical trial results before proceeding with formal partnership negotiations.

Now that the company has the major US patent, what is your next step?
We hope to complete the Canadian human clinical trial of VitroGro for the treatment of diabetic, venous and pressure ulcers in the second quarter of 2009.

However, in the fourth quarter of 2009 we will scale up manufacture of new formulation VitroGro to increase Tissue Therapies margins and increase sales volume. The Health Canada and Ethics approval for human trial of large scale VitroGro is expected to be completed in the beginning of 2010. While, regulatory approval for the new formulation is expected in 2011.

What challenges the company faces in taking VitroGro to the market?
Since the listing of Tissue Therapies on the Australian Stock Exchange in 2004, many of the initial risks involved in the commercialization of VitroGro have been significantly reduced. This is evident from the various milestones achieved in the last 18 months.

The only real challenges that remain are the completion of the Canadian clinical trial and the successful conclusion of negotiations for the manufacture and worldwide sales and distribution of VitroGro wound care products.

Will the current economic slump affect the company’s plans for the product in any way?
The current world financial situation has certainly made further fund raising more difficult than previously. However, with more than seven years of detailed scientific data from laboratory work with human skin and excellent human clinical results now from the Australian and the partly completed Canadian human trials, Tissue Therapies believes that sufficient commercially important progress has been made to attract the funding necessary to complete the commercialization of VitroGro.

VitroGro offers the opportunity to take a practical and fundamental advance in the treatment of chronic wound healing, a world market of $4 billion growing at 11—15 percent per annum.