CV Technologies Inc., (TSX:CVQ) today announced preliminary results of a clinical trial demonstrating that COLD-FX® significantly supplements the flu shot’s effectiveness in seniors and cuts colds and flu by one-third. This result was obtained through a randomized, double-blind, placebo-controlled multi-centre trial investigating the potential benefit of supplementing the flu shot in seniors with COLD-FX, the Company’s lead product and Canada’s number one selling cold and flu remedy.
The multi-centre trial involved 780 healthy seniors who took the flu shot just prior to the six-month treatment phase of the study, which was led by Dr. Gerald Predy, Medical Officer of Health for Alberta Health Services. Dr. Predy collaborated with Dr. Janet McElhaney, an internationally recognized influenza expert and Division Head, Geriatric Medicine at the University of British Columbia and Providence Health Care, and infectious disease experts Dr. Andrew Simor, Head of Infectious Diseases and Microbiology at Sunnybrook Health Sciences Centre in Toronto, and Dr. Shelly McNeil, Associate Professor of Internal Medicine at Dalhousie University.
Commenting on the trial, Dr. Predy said: “Considering the risks that upper respiratory infections present to seniors in particular, it’s encouraging that the study showed greater protection when COLD-FX is taken in addition to the flu shot."
Participants took daily doses for six months of either 400 milligrams of COLD-FX (standard dose), 800 milligrams of COLD-FX (high – double the standard dose), or a placebo. They were asked to report respiratory infections and record their symptoms. The study addressed viruses responsible for cold and flu symptoms. Throat swab samples were taken from anyone reporting an infection and analyzed for viruses known to cause upper respiratory infections. The viral analysis was conducted in the lab of internationally recognized flu expert, Dr. Albert Osterhaus. Based in the Netherlands, Dr. Osterhaus is one of the world's leading virologists and utilizes the most sensitive test methods available.
For prevention of colds and flu (and symptomatic relief), Health Canada has approved daily use of 400 milligrams of COLD-FX. CV Technologies has a product license and natural product number (NPN) for COLD-FX. Recently launched COLD-FX Extra Strength, which is recommended for acute symptom relief (in 1,800-, 1,200- and 600-milligram doses on three successive days), was not studied in the multi-centre trial.
Investigators used two principal methods of verifying upper respiratory infections in trial participants: Jackson-confirmed (a rigorous and validated scientific tool for assessing clinical symptoms) and laboratory confirmed. While both methods were utilized, the Jackson method is actually more sensitive than laboratory testing in confirming symptomatic upper respiratory infections and gauging their severity.
Compared to study participants who took the placebo, the mean number of Jackson-confirmed upper respiratory infections per person was 36% lower in the standard dose COLD-FX group and 33% lower in the high dose COLD-FX group. In other words, both COLD-FX doses produced similar and statistically significant reductions in the number of upper respiratory infections per individual relative to the placebo.
Considering the groups as a whole, the number of Jackson infections experienced by the standard group was 31% less than the placebo group, while infections for the entire high dose group were 33% below the result for the placebo group. The difference in result between the placebo group and the COLD-FX groups was statistically significant – but the differences between the two COLD-FX groups were not.
Additional trial results consistent with these findings may be clarified during the peer review process and published in a scientific journal. Among these are reductions in the severity and duration of Jackson-confirmed infections in the COLD-FX groups, and an indication that COLD-FX may decrease the proportion of severely symptomatic infections among all infections confirmed in the lab.
“We are very proud of our research accomplishments. Information gained from COLD FX studies at New Jersey's Hackensack University Medical Center, Hamilton, Ontario’s McMaster University, and our multi-centre trial, collectively suggest that taking COLD-FX daily is a good preventative measure and that COLD-FX may have the potential to be an adjunct to various types of vaccines,” said CV Technologies’ President, CEO and Chief Scientific Officer, Dr. Jacqueline Shan. “The most recent trial confirms earlier findings and demonstrates a key benefit to seniors, since aging is associated with declining immune function and greater vulnerability to infection. There is a good basis for exploring the potential advantages to other immune deficient populations of using COLD-FX. From a corporate perspective, we are setting the stage for new products and applications that we expect will drive CV Technologies’ future success.”
The safety and tolerability of both COLD-FX doses was validated by the study results. Adverse events were not statistically significantly different than for the placebo group, with one notable exception: a reduction in cardiovascular events in both COLD-FX dose groups. The implications of this result are consistent with the efficacy of COLD-FX in reducing upper respiratory infections, which are known to be associated with adverse cardiovascular events in seniors.
“We are intrigued by the study’s finding of a statistically significant reduction in cardiovascular adverse events in the COLD-FX groups, compared to the placebo group,” Dr. Shan said. “While we did not set out to study this possibility, we obtained the result through an assessment of safety aspects of the trial. This is a potential new application for COLD-FX which, if pursued, would require more in-depth review.”
From a technical perspective, there was no statistically significant difference relative to placebo in the proportion of infections confirmed by the following two methods: both laboratory and non-Jackson symptom-based testing, and lab testing alone. The difficulty of reaching statistical significance regarding these parameters is likely related to a couple of factors, including:
• the overall low absolute number of infections in the two study seasons, and the unprecedented low rates of influenza during these periods – circumstances beyond the study’s control; and
• laboratory analysis produced a positive or negative result but did not indicate "viral load" – that is, the amount of virus in the body. Accordingly, COLD-FX may have moderated the degree of infection present – but this possibility was not tested under the study design.
“I am very pleased with the results and I admire CV Technologies' dedication to research, as well as its commitment to subjecting its natural products to the highest standards of clinical testing," Dr. McElhaney remarked.
Experts estimate that flu-related complications are the fourth leading cause of death for North American adults over 65 years of age.
"The trial’s results indicate that COLD-FX did have a beneficial effect in reducing the incidence of respiratory illnesses in a generally healthy elderly population," said Dr. Simor.
Previous study results published in the Canadian Medical Association Journal showed that COLD-FX reduced the incidence and frequency of recurrent colds by more than half in healthy adults, cut colds’ duration and reduced their severity.
Apart from COLD-FX, there is no known clinically proven therapy for both prevention and treatment that naturally enhances the immune system to fight viral respiratory infections. The flu shot is designed to defend against influenza virus infections and is particularly important in adults older than 65 years. However, there is a need for additional complementary therapies since the flu shot does not provide complete protection against influenza or prevent infection with other viruses that cause influenza-like illness, such as RSV. Antiviral medications are also not completely effective and the influenza virus can develop resistance to them. Since COLD-FX works by boosting the body's own immune system, its benefits are not virus-specific and viruses cannot develop resistance to COLD-FX.
“One way in which CV Technologies measures its success is the degree to which we positively impact public health through the use of our products,” Dr. Shan said. “The multi-centre trial adds to the body of knowledge establishing that COLD-FX significantly strengthens seniors’ defenses against upper respiratory infections. The positive findings of the trial help create long-term value for consumers and for CV Technologies’ shareholders as well.”
About the Trial
The trial was approved by Health Canada and all appropriate research ethics committees. Each study participant was enrolled for a single half-year period. The trial ran during the six-month 2005/2006 and 2006/2007 cold and flu seasons, with the analysis phase proceeding after that time; consistent with normal scheduling and standard industry practice for a research study of this size and complexity. It was conducted under blinded conditions, ensuring study integrity because it was not known which subjects took COLD-FX and which ones consumed a placebo.
ABOUT CV TECHNOLOGIES INC.
CV Technologies, founded in 1992, strives to transform people’s lives to be healthier and happier by focusing on prevention and recovery through the use of evidence-based naturally-derived health products. The Company's lead product COLD-FX® strengthens the immune system and is widely used as a leading over the counter (OTC) remedy for helping to prevent and relieve cold and flu infections. COLD-FX continues to rank as the number one selling cold and flu remedy in Canada (ACNielsen’s MarketTrack Drug Service for Cold Remedies, Natural Supplements & Vitamins Categories for the 52 week period ending July 5, 2008).
Forward Looking Information
This news release contains certain forward-looking information within the meaning of applicable securities laws. The forward-looking information included in this document does not guarantee future performance and should not be unduly relied upon. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information including, without limitation, those comments relating to clinical trials and clinical trial results or the initiation of potential future clinical trials. The Company believes that the expectations and assumptions reflected in the forward-looking information contained herein are reasonable but no assurance can be given that these expectations and assumptions are correct or that any benefits may be derived from the preliminary results of the clinical trial or from the results of the peer review of the data. 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.