600 Edmonotnians to be Recruited For Trial to Help Cold and Flu Sufferers
Edmonton, AB (CVQ - TSX VEN). CV Technologies Inc. today announced Dr. Gerry Predy, Medical Officer of Health, Edmonton Capital Health will conduct the 8th clinical trial of COLD-fX(r) to see if it can stop the development of viral respiratory infections. This is the first formal clinical trial launched in Canada under Health Canada's new NHP regulations. On January 1, 2004 Health Canada set up a directorate to register and monitor all natural health products in a manner similar to drugs.
CV Technologies President, CEO and Chief Scientific Officer, Dr. Jacqueline Shan said, "We need safe, effective and scientifically proven ways to prevent and treat colds and the misery they bring to so many people. Successful efforts in this area can reduce the cost to the health system, the pressure on clinics and emergency rooms, and of course - most importantly - bring relief to cold sufferers.
Dr. Predy said today, "We know that each year colds and flu hit a significant number of people world-wide. This year the flu hit us especially early and Health Canada reports that 50,000 lab tests have already been done and so far there have been more than 9,000 confirmed cases reported. That figure of course, doesn't include colds."
Dr. Predy said, "Estimates suggest colds and flu hit roughly 4 million Canadians each year. That's a big incentive for people in my field of public health to seek out ways to protect them. This trial will be looking at COLD-fX(R) to see if acute and short term use of COLD-fX(R) can shorten the severity and duration of colds in a cross section of the population."
Dr. Shan said, "The launch of this trial further demonstrates our continued commitment to science and to maintaining a leadership role in providing evidence-based, safe and effective natural health products for consumers. Our goal is to offer Canadians products for health maintenance and disease prevention"
The new NHP regulations require formal double blind, placebo-controlled clinical trial results to support the highest level of medical claims for a natural health product. COLD-fX(R) is one of the few products which qualifies in this category.
Dr. Shan said, "Both the industry and consumers have been waiting for the new regulations to be implemented. This is a great step forward which will allow consumers to know which products meet the new standards for safety, efficacy and consistency and which don't and which are in the process of doing so. Natural health products in future will have labels with clear directions about use and warning about possible side effects. It's a booming field with 30,000 natural health products and until now with no regulations".
Dr. Shan added, "The end of the regulatory limbo that natural health products have been in for years should come as welcome news to the 68% of Canadian consumers who, according to a Health Canada survey, use supplements to help keep themselves healthy."
She said, "COLD-fX has completed six clinical trails, launched the 7th preventative trial in the fall of 2003. That trial was approved by the Therapeutic Product Directorate of Health Canada. The results from that trial will be available between summer and fall of this year. Now we are beginning our 8th trial. Each trial tells us more about COLD-fX's(R) performance for different purposes and with different segments of the population.
COLD-fX is the only known natural health product in Canada that is undergoing formal clinical trials approved and in compliance with both Health Canada's Drug and Natural Health Product Regulations. COLD-fX(R) is also the first and only known natural health product in the world to complete U.S. FDA regulated Phase II, double blind, placebo-controlled trials. The result of those trials involving seniors in 5 U.S. nursing homes show that COLD-fX(R) reduced the risk of getting a cold or flu by 89%. That study was published in the January 2004 edition of the respected Journal of the American Geriatric Society
Six hundred Edmontonians are to be recruited for the trial, which will begin in the next couple of days. The trial was also approved by the Health Research Ethics Board of Edmonton Capital Health.
ABOUT CV TECHNOLOGIES INC.
CV Technologies, founded in 1992, aims to become a global leader in the development, distribution, marketing and selling of safe and effective natural health products for disease prevention and health maintenance. CV's products are unique because they are developed and standardized according to the company's ChemBioPrint(TM) technology, a patented process that precisely identifies the chemical profile and biological activity of natural health products. This is a combination of chemical and pharmacological fingerprinting that ensures each batch of product delivers verifiable and provable health benefits, and is both safe and consistent with previous batches.