CANADA APPROVES TISSUE THERAPIES TRIAL, WA PATIENTS IMPROVE
November 14th 2008 07:33
Tuesday November 11, 2008
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* CANADA APPROVES TISSUE THERAPIES TRIAL, WA PATIENTS IMPROVE
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TISSUE THERAPIES
Tissue Therapies has received approval from Health Canada for a trial of its Vitrogro wound care product for the treatment of diabetic, venous and pressure ulcers.
At the same time the company says that non-healing venous ulcers in the third and fourth patients of eight in its Western Australia trial had shown significant improvement.
The Canadian approval was expected in December 2007 but was delayed several times.
Tissue Therapies chief executive officer Dr Steven Mercer told Biotech Daily that the final approval mechanism began late last week, with all participants including ethics committees and the clinical trials team signing-off over the weekend and yesterday.
Dr Mercer said the 30 patient trial would begin in Toronto on Monday November 17, 2008.
In separate announcements, Tissue Therapies said the third patient in its Australian trial had a 46 percent reduction in wound area after 24 days of treatment, with Vitrogro applied twice weekly for the first two weeks of the trial.
As with the first two patients, the third patient had a noticeable improvement in tissue health at the edge of the ulcer, the company said.
The third patient was a 78-year-old female who had the venous ulcer for two years and had undergone unsuccessful compression therapy for more than one year.
Prior to the study the patient had varicose veins surgically removed from the leg with the treated ulcer. This may have assisted in the reduction in wound area.
The fourth patient was a 68-year-old female who had suffered from her venous ulcer for six months and had undergone unsuccessful compression therapy for seven weeks prior to taking part in the clinical trial of Vitrogro.
Tissue Therapies said there was a rapid reduction in wound area during Vitrogro treatment but “some increase in ulcer size after the Vitrogro therapy was stopped”.
This may have been due to excessive wound fluid water-logging the skin adjacent to the ulcer, Tissue Therapies said.
This patient had an unusually slow heart rate for a short period during the week after Vitrogro treatment had stopped.
There were no adverse medical consequences from this and there is no identifiable link between the treatment and the episode of slow heart rate, the company said.
Dr Mercer said results from the trial at the Vascular Research Laboratory in Fremantle had been “exceptional”.
“Trial results of Vitrogro on patients suffering from debilitating venous ulcers have so far been very positive, demonstrating its rapid wound healing properties and as yet there have been no indication of adverse reactions from its application,” Dr Mercer said.
“The expected positive results from the human trials in Australia and Canada, combined with our product classification, are likely to lead to the commercialization of Vitrogro within two years for widespread use on chronic ulcers - a market estimated to be worth $US4 billion annually worldwide,” Dr Mercer said.
Tissue Therapies chief scientific officer Prof Zee Upton said receiving human trial data that reflected the success achieved in the laboratory was encouraging.
“It is a wonderful feeling to see the practical application of so much scientific effort pay off with patients being treated with Vitrogro,” Prof Upton said.
“This is the stuff biological scientists dream of, particularly when we are working towards the ability to accelerate chronic wound healing and relieve a huge number of people of the pain, disability, social isolation and often literally threats to life and limbs these chronic wounds cause,” Prof Upton said.
Results are expected to be released during the Canadian trial, starting in late 2008, with final results available during the first half of 2009.
Tissue Therapies was unchanged at 10 cents.
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