Health Canada approves significant new medical claims for COLD-fX

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CV Technologies Inc. announces that Health Canada has approved wide-ranging new health claims for COLD-fX. After an extensive review, the Natural Health Products Directorate (NHPD) - Health Canada's division responsible for evaluating the safety, efficacy and quality of natural health products (NHPs) - has issued a product license and natural product number (NPN) for COLD-fX.

The comprehensive treatment claim for COLD-fX approved by Health Canada states that the product "helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system." Comprehensive therapeutic claims require support by the highest level of scientific evidence: randomized, double-blind, placebo-controlled clinical trials.

"This is our strongest point of medical recognition to date and coming from the government authority whose responsibility it is to help Canadians maintain and improve their health, this approval should give great confidence to consumers," said Dr. Jacqueline Shan, president, CEO and chief scientific officer of CV Technologies.

"There are two novel therapeutic aspects to COLD-fX. First, COLD-fX is one of the very few medicines - drugs or natural health products - that Health Canada has approved for daily use as a preventative medicine. Second, COLD-fX can be taken to provide symptom relief for colds and flu. This decision is important because we believe there are currently no other medicines today that are approved to fight colds and flu by enhancing the immune system."

"After more than 10 years of research and seven clinical trials, this approval from Health Canada is a breakthrough in realizing our vision of being a global leader in developing products for disease prevention," said Dr. Shan, pointing out that Health Canada reviewed all of the company's published and unpublished data in approving these claims. "This is one of the most important milestones in the history of the company and should stimulate significant interest in the medical community."

The NHPD issues product licenses in several categories. Because COLD-fX is a unique patented product, it was issued an NPN in the non-traditional category, which requires the highest level of scientific evidence. In contrast, claims with the term 'traditional' are not based on scientific evidence and products in the 'monograph' category have claims which are not supported by specific research on their particular product.

"There's no cure for the common cold," Dr. Shan stated. "So, in medicine the traditional strategy is if you can't treat the disease, you treat the symptoms. The COLD-fX strategy is to boost your immune system to help you avoid getting a cold or the flu in the first place, or if you do get one, to fight it more effectively. Other products tend to mask symptoms without treating the underlying cause. We hope that COLD-fX will become the 'standard of care' for colds and flu."

The NHPD's safety review confirmed the excellent safety profile of COLD-fX with no known side effects or drug interactions for generally healthy individuals. This is very rare as most approved medicines, including over the counter cough and cold products, are associated with some adverse side effects.

Health Canada established new regulations effective Jan. 1, 2004, to monitor and manage the NHP industry. CV Technologies was the first company in Canada to launch and complete a trial under the new regulations. These regulations are being phased in over a six-year period as the NHPD reviews supporting safety, efficacy and quality information for all natural health products.