New Zealand clinical trial results point to promising global wound management opportunities

Wool biologic material technology finds use in application for wound healing

CHRISTCHURCH, NEW ZEALAND, October 2, 2006:

Keratec Limited and US-based Keraplast Technologies Limited today announced the successful completion of a human clinical trial of their patented Keragen™ range of chronic wound treatment products. The results showed sufficient promise to clear the way for further more comprehensive trials.Twenty-two patients participated in the non-randomised open-label clinical study. Seventy-seven percent of the patients showed healing improvement and 18 percent completely healed. Overall, 91 percent of the patients and 86 percent of nurses preferred the Keragen dressings to their usual dressings. The study showed that the products performed well and cleared the way for further research.

Fertram Sigurjonsson, Keratec’s executive in charge of the collaborative wound healing programme, said that the successful completion of the study sets the scene for significant future developments in the biologic material area for Keratec and its partner Keraplast Technologies.

"In the US alone more than five million people suffer from chronic wounds caused by diabetes, circulatory problems and other health issues.

There is a great need for new technologies to help these people."

"We are extremely pleased with the results of the study and are working to develop the Keragen wound treatment platform further and make our products available to healthcare professionals around the world," Mr Sigurjonsson said.

The Keragen products utilise Keratec’s and Keraplast’s Functionalized Keratin™ biologic material platform. The patented technology makes keratin, a protein that is a main constituent in skin and hair, soluble while maintaining the protein’s functionality. Normally when keratin is made soluble it is de-natured by chopping up the various parts in a process called "hydrolysis".

The partners have developed gentle methods of extracting keratin from wool in a soluble, functional form by separating wool fibre into its constituent keratin parts without destroying the different fractions. These "functionalized keratins" are then available to the body as if they were the body’s own keratin supply, to strengthen biological systems.

Keratec’s CEO Bruce Foulds said that with several ranges of Functionalized Keratin products now in various stages of commercialisation, Keratec is pleased at the progress being made in successfully leveraging a core technology through several different pathways to market.

"This trial allows us to accelerate the development of a biomedical product targeting a fast-track entry to a rapidly growing global market," he said.

Keratec’s Chief Scientific Officer Dr Rob Kelly said the clinical trial results are consistent with the findings of two papers published in the international science magazine Nature (Nature.

2006 May 18;441(7091):362-5.) in May. In this publication researchers from Johns Hopkins School of Medicine had, for the first time, identified the important role that keratins play in wound healing. "Keratin is receiving a lot of attention from the international science community at the moment, and we are very excited to be at the forefront of keratin biologic material science" Dr Kelly said.

Keratec and Keraplast Technologies will continue their human clinical trial programme, with further results expected in mid-2007.

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