Edmonton, AB (CVQ – TSX) CV Technologies today announced positive safety results in a pilot clinical trial as the first step in developing a children’s formulation of COLD fX® - the # 1 selling cold and flu remedy in Canada.
The randomized, double-blind, placebo-controlled study was designed to measure the safety and tolerability of COLD-fX for treatment of cold and flu in children. Acute three-day doses of COLD-fX were well tolerated with no serious adverse events, or differences in adverse events versus the placebo group. The research was also successful in determining effect size, which enables appropriate statistical planning of a potential efficacy study.
“There is clearly a great need and substantial market for a safe and effective product to treat cold and flu in children, who suffer from these ailments much more often than adults,” said Jacqueline Shan, PhD, DSc, President, CEO and Chief Scientific Officer of CV Technologies. “While further clinical studies are needed before COLD-fX can be recommended for those under 12, the results of our research are promising for development of a children’s formulation. We are evaluating plans for the next stage of our pediatric research, as one element of our strategy to expand our product pipeline.”
Seventy-five children between the ages of three and 12 were recruited in Edmonton for the study, which was conducted in the winter of 2005-2006. Of those children, 46 developed an upper respiratory tract infection (URTI) and they were randomly assigned to receive acute three-day treatment with either a placebo or COLD-fX (two weight based dosage levels).
The trial was approved by Health Canada and the University of Alberta Ethics Committee and conducted in collaboration with pediatric researchers in the Faculty of Medicine at the University of Alberta, Edmonton, Canada. The findings were presented at two major scientific conferences, including the Annual Symposium on Complementary Health Care in Exeter, England, the longest running conference in its field.
This is the first time COLD-fX, a naturally derived extract of North American Ginseng, has been studied for use in children. It comes at a time when Health Canada and the FDA in the U.S. are reviewing the dosage and efficacy of roughly 800 children’s cough and cold remedies, particularly for children under the age of six. A recent study by the Centers for Disease Control and Prevention (CDC) says over 7,000 children under 12 are treated each year in U.S. hospital emergency rooms for adverse drug reactions from cough and cold medications.
ABOUT CV TECHNOLOGIES INC.
CV Technologies, founded in 1992, is a global leader in the development and commercialization of naturally derived, evidence based, natural therapeutics for disease prevention and health maintenance. The Company's lead product - COLD-fX® - strengthens the immune system and is widely used as a leading over the counter remedy (OTC) for preventing and relieving cold and flu infections. In the United States it is marketed as an immune enhancing dietary supplement. COLD-fX continues to rank as the number one selling cold and flu remedy in Canada (ACNielsen’s MarketTrack National all Channel service for the categories of Cold Remedies and Supplements & Products, 52 weeks ending December 22, 2007). COLD-fX®, with its unique and patented mechanism of action was standardized according to the Company's ChemBioPrint (CBP) Process. The CBP process precisely identifies the chemical profile and biological activity of multi-active compounds in evidence-based natural therapeutics. The CBP process also provides a manufacturing protocol that ensures each batch of the final product delivers verifiable and provable health benefits.
Forward Looking Information
This news release contains forward-looking information that is subject to risks and uncertainties that may cause actual results or events to differ materially from the results or events predicted in this document, including those comments predicting the timing and/or initiation of clinical trials, particularly those related to pediatric clinical trials, clinical trial results and associated regulatory clearances, new areas of potential development for our platform technology and whether or not those areas will be pursued. Factors which could cause actual results or events to differ include, but are not limited to: the impact of competition; consumer confidence and spending levels; general economic conditions; interest and currency exchange rates; unseasonable weather patterns; the cost and availability of capital; the cost and availability of grants/funding; product development and the risk that clinical trials may not demonstrate the safety and efficacy required to satisfy the regulatory authorities. Although we believe that the forward-looking information contained herein is reasonable, we can give no assurance that our expectations are correct and that the results, performance or achievements expressed in, or implied by, forward-looking information within this disclosure will occur, or if they do, that any benefits may be derived from them. All forward-looking information is expressly qualified in its entirety by this cautionary statement. The Company assumes no duty to update or revise forward looking information, except as may be required pursuant to applicable laws. The Company is a 12g3-2(b) SEC registrant.