CV Technologies Inc. (TSX VENTURE:CVQ): The Canadian Medical Association Journal - regarded as one of the five top general medical journals in the world - will tomorrow publish a landmark double-blind, placebo-controlled study on the prevention and relief of upper respiratory infections. The clinical trial was conducted on the anti-cold, anti-flu remedy, COLD-fX(R) by Edmonton's Medical Officer of Health and a senior Canadian researcher who called the results 'statistically highly significant'.
The trial results show that COLD-fX(R) reduced the incidence and frequency of recurrent colds by more than half. It also cut the duration of colds and significantly reduced their severity.
The number of upper respiratory infections in each subject was significantly reduced by 25% in the COLD-fX(R) group during the 4 month treatment period. Even more impressive however, was the finding that recurrent infections were reduced by 56% (10.0% in the COLD-fX(R) group v. 22.8% in the placebo group, an absolute difference of 12.8%). COLD-fX(R) treatment also had a significant effect in reducing the total symptom score and the duration of infections. The incidence of adverse events was low and the prevalence was found to be similar between the two groups.
The trial was conducted by internationally respected Nutritional Biochemist, Dr. Tapan Basu, a professor at the University of Alberta, and Edmonton's Medical Officer of Health, Dr. Gerry Predy of Capital Health.
The study involved 323 adults from the general population (18-65 years of age) with a history of at least two upper respiratory infections in the previous year. Participants were given either COLD-fX(R) or a placebo for four months during the winter of 2003/04. Subjects graded the severity and duration of their respiratory-related symptoms on a 4-point scale. All analysis was performed by a University of Western Ontario biostatistician under blinded conditions.
The authors of the study concluded that the COLD-fX(R) treatment appeared to be an attractive natural prophylactic treatment for upper respiratory infections. Regular intake of COLD-fX(R) was shown in the clinical trial to be effective not only for the prevention of upper respiratory infections, but also for relief of symptoms if an infection did occur. The results were similar to those observed in previous clinical studies on COLD-fX(R).
Dr. Basu said, "One of biggest challenges in clinical studies with natural based compounds is the lack of standardization of the testing material. Most natural health products do not offer batch-to-batch consistency and do not produce consistent clinical results. This trial was unique in that it examined a unique natural extract with the same rigor used for conducting trials of drug candidates in the pharmaceutical industry, a practice that is rarely found in the natural health product business."
"We are interested in the potential positive implications for our residents and the results from clinical trials done to date are encouraging," said Dr. Predy. "For example, in participants taking COLD-fX(R) daily for prevention, recurrent infections were reduced by more than half. In addition, there was a 31% reduction in the severity of their symptoms."
CV Technologies Inc. CEO and Chief Scientific Officer and co-discoverer of COLD-fX(R), Dr. Jacqueline Shan said, "This is the first publicly known study to be completed under the new regulations established by Health Canada's
Natural Health Product Directorate. We were pleased that the Canadian Medical Association Journal decided to publish the study. Like all published clinical trials it has undergone a rigorous peer-review process by experts chosen by the Journal".
In two previous trials involving 198 nursing home seniors conducted under FDA's drug regulations by Dr. Janet McElhaney, the newly appointed head of geriatric medicine at the University of British Columbia, COLD-fX(R) showed an 89% reduction in clinical illness caused by influenza and cold viral infection confirmed by virological testing. The four month study conducted while Dr. McElhaney was a professor at Eastern Virginia Medical School also demonstrated an excellent safety profile in that group. The results of that study were published in 2004 in the peer reviewed Journal of the American Geriatrics Society.
A multi-centre and multi-dosage, double-blind, placebo-controlled clinical trial on COLD-fX(R) involving 720 community living healthy seniors was launched this month in Canada. This trial is being jointly conducted by Dr. Gerry Predy, Medical Officer of Health in Edmonton, Dr. Andrew Simor, a leading infectious disease expert and the head of microbiology at Sunnybrook and Women's College Health Sciences Centre in Toronto and Dr. Janet McElhaney, an internationally recognized influenza expert and head of geriatric medicine at the University of British Columbia in Vancouver.
COLD-fX(R) is a proprietary, commercially available natural health product developed and manufactured by CV Technologies. It is the result of more than ten years of scientific and clinical research by a team of 25 scientists. It is standardized by the company's proprietary ChemBioPrint (CBP(R)) technology to ensure batch-to-batch consistency and efficacy. In lab and clinical studies it has been shown to have an excellent safety profile.
ABOUT THE CANADIAN MEDICAL ASSOCATION JOURNAL:
The CMAJ was founded in 1911 and publishes every 2 weeks. It is distributed to over 60,000 physicians. The CMAJ receives 2,000 manuscripts a year including letters to the editor and news articles. Its acceptance rate for unsolicited research and review articles is about 12%. It is regarded as one of the top five general medical journals in the world - the others being the New England Journal of Medicine, Journal of the American Medical Association, The Lancelet and the British Medical Journal. The CMAJ website receives about 1 million requests and 250,000 downloads per month. The Journal is part of the PubMed Central Collection of Journals at the National Library of Medicine in Washington, D.C.
Principal Clinical Investigators:
Dr. Tapan Basu studied in the Department of Nutritional Biochemistry at the University of London and received his doctorate from the University of Surrey in 1971. He has written extensively on nutrition and pharmacology including 6 books and 158 papers and abstracts. He is or has been a member of advisory boards for professional publications like the British Journal of Nutrition and has played a key role in international conferences on clinical nutrition in six different countries. He holds 9 awards or honors for his work and has received research grants from five countries. He holds memberships in 12 professional societies including the British Society of Surgical Oncology and is a fellow of the American College of Nutrition.
Dr. Gerry Predy received his doctorate in medicine from the University of Alberta in 1976 and holds a Fellowship in the Royal College of Physicians and Surgeons (Canada) in Community Medicine. Since 1996 he's been the Medical
Officer of Health for the Capital Health Region in Alberta - the largest integrated academic health region in Canada. He supervises 170 public health nurses, inspectors and health care workers involved in public health programs. He's the Director of the Northern Alberta Vaccine Trials and Evaluation Centre and has conducted research in a number of public health areas. He's also the former chair of the Council of Medical Officers of Health. Capital Health operates medical facilities including 10 hospitals and employs more than 18,000 health care workers.
ABOUT CV TECHNOLOGIES INC.
CV Technologies was founded in 1992. It aims to become a global leader in the development and commercialization of evidence based, natural medicines for disease prevention and health maintenance. CVT's lead product - COLD-fX(R), - the top selling cold/flu remedy in Canada according to ACNielsen, strengthens the immune system and is widely used as a leading anti-cold, anti-flu, non-prescription treatment. COLD-fX's unique, patented, mechanism of action was developed and standardized according to the Company's ChemBioPrint (CBP(R)) technology. The CBP(R) process precisely identifies the chemical profile and biological activity of multi-active components in natural compounds. The CBP(R) process provides a manufacturing protocol that ensures each batch of compound delivers verifiable and provable health benefits.
This news release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. For this purpose, any statements that are contained herein
that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes", "anticipates", "plans", "intends", "expects" and similar expressions are
intended to identify forward-looking statements. Such risks and uncertainties include, but are not limited to, the need for capital, changing market conditions, completion of clinical trials, patient enrolment rates, uncertainty
of pre-clinical, retrospective and early clinical trial results, the establishment of manufacturing processes and new corporate alliances, the timely development, regulatory approval and market acceptance of the Company's
products, and other risks detailed from time to time in the Company's filings with Canadian securities authorities.
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