CV Technologies Inc. (TSX:CVQ) today announced preliminary results suggesting that COLD-FX® affects the human immune system by targeting the adaptive pathway, which is the immunity developed throughout life. This result was obtained through a randomized, double-blind, placebo-controlled trial of the company's cold and flu remedy, COLD-FX, demonstrating its immune-modulating effects in front-line healthcare workers at New Jersey's prestigious Hackensack University Medical Center (HUMC).
The study was led by HUMC infectious diseases researcher Dr. Steven Sperber and extended previously published clinical research showing that regular intake of COLD-FX over a single cold season enhanced Natural Killer (NK) and T-helper cells, which are part of the body's immune defense system.
Study participants were 50 healthy staff members from HUMC who were given either COLD-FX or a placebo. They consumed 1800, 1200, and 600 milligrams per day, respectively, on three consecutive days. Before and after each of the three days, blood samples were assessed for immune factors that are highly sensitive and therefore render a 50-person sample size statistically significant.
The results indicate that COLD-FX affects adaptive immunity, which is acquired through exposure to viruses and other infectious agents over time. Specifically, statistically significant results showed that T-helper lymphocytes - which contribute to adaptive immunity - rose after three days in the COLD-FX group but not in the placebo group.
Also of interest in the study was a statistically significant decrease in reported adverse events in the COLD-FX group compared to the placebo group. The implications of this are encouraging and consistent with some earlier scientific findings.
Interpreting the HUMC trial is complex since human immunity levels are constantly in flux to some degree even in healthy individuals. Its findings require further evaluation to understand certain immunological parameters and the mechanism of action of COLD-FX, including whether COLD-FX affects the innate pathway - immunity present at birth. However, the data available so far appear to confirm previous findings that COLD-FX targets the adaptive immune response. The results will be subjected to peer review in the near future.
"We are pleased with the results and with the opportunity to have HUMC's strong research capability focused on COLD-FX," said Dr. Jacqueline Shan, President, CEO and Chief Scientific Officer of CV Technologies. "While COLD-FX has already been clinically proven to be effective, the latest trial provides further insight into how COLD-FX works on an immunological level. We expect this research to be of particular interest to the scientific and medical communities."
The HUMC study complements findings obtained through ongoing Canadian government-funded research at McMaster University in Hamilton, Ontario on the precise molecular mechanism of action of COLD-FX. Results obtained to date through the McMaster research were presented at scientific conferences earlier this year and indicated that COLD-FX activates the immune system to produce certain anti-viral factors through MyD88 cell signaling, implicating specific Toll-like receptors.
The trial was reviewed and approved independently by the U.S. Western Institutional Review Board.
About Dr. Steven Sperber
Dr. Steven Sperber is an infectious disease expert who studied at New York University, where he received his doctorate in 1982. He is a Clinical Associate Professor of Medicine in the Division of Infectious Diseases, University of Medicine and Dentistry of New Jersey. Dr. Sperber has participated in trials involving category-related products like echinacea, nonsteroidal anti-inflammatory drugs, and pseudoephedrine plus acetaminophen. He has written in numerous peer reviewed medical journals and has an interest in respiratory viral infections. Dr. Sperber is a fellow of the American College of Physicians and the Infectious Diseases Society of America.
Hackensack University Medical Center
Hackensack University Medical Center, a 781-bed teaching and research hospital affiliated with The University of Medicine and Dentistry of New Jersey - New Jersey Medical School, is the largest provider of inpatient and outpatient services in the State of New Jersey. Founded in 1888 with 12 beds and as Bergen County's first hospital, Hackensack University Medical Center has demonstrated more than a century of growth and progress. Today, this not-for-profit, tertiary-care, teaching and research hospital serves as the hub of healthcare for northern New Jersey and the New York metropolitan area. It includes more than 1,400 physicians and dentists on the medical and dental staff, 89% of whom are board-certified in their sub-specialty. The medical center adds an average of 100 doctors a year. Hackensack has received the Hospital Award for Clinical Excellence, which puts it in the top 5% in the U.S. for clinical quality performance. It has been ranked as one of America's top hospitals by U.S. News & World Report.
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. 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.
FOR FURTHER INFORMATION PLEASE CONTACT:
CV Technologies Inc.
Warren Michaels, Vice President, Communications
Email: [email protected]