Hackensack, NJ. CV Technologies Inc. (TSX :CVQ) today announced that doctors and nurses at Hackensack University Medical Centre (HUMC) in New Jersey will participate in an important randomized, double-blind, placebo-controlled trial of Canada’s popular cold remedy to see if it can improve the immune health of front line medical workers.
HUMC infectious diseases researcher, Dr. Steven Sperber, will head the study which will include blood tests to investigate the hypothesis that COLD-fX® works by simultaneously boosting two different immune pathways: the innate response (macrophages and Natural Killer (NK) cells) and the Th1 adaptive response. Both pathways are critical for fighting viruses and maintaining good health. The hypothesis is supported by previously published clinical research which demonstrated that regular intake of COLD-fX® over one cold season enhanced NK cells and T-helper cells.
If confirmed, COLD-fX® will be the first dietary supplement clinically proven to work synergistically by enhancing both of these immune pathways. There are currently no approved medicines which act in this novel manner. The study will complement additional Canadian government-funded research being conducted at McMaster University in Ontario on the precise molecular mechanism of action of COLD-fX®.
Dr. Sperber is recruiting 50 healthy staff members from HUMC for the trial including doctors and nurses. The number was calculated to be sufficient to detect statistically significant differences between the study groups. The parameters being measured are blood immune factors which are highly sensitive and therefore don’t require a high number of trial subjects.
COLD-fX® has been the subject of a number of clinical trials in universities in both Canada and the U.S. and data has been published in nine peer-reviewed medical journals, including the prestigious Canadian Medical Association Journal.
Dr. Thomas Selvaggi, Director of Special Immunology at HUMC says, “This is an exciting research initiative for us and we hope it will ultimately lead to advances in the prevention or treatment of upper respiratory viral infections through immune-enhancement. We’ve been impressed with CV Technologies’ commitment to research and of its trials to date. HUMC has played a leadership role in a variety of scientific fields and we hope that the results may provide some benefit to front line health care workers who are among the people most at risk of infections. We have been successful at the Medical Center through various programs at reducing absenteeism among our staff so we are keen to be involved in anything that further protects our workers.”
Dr. Jacqueline Shan, president, CEO and Chief Scientific Officer of CV Technologies, maker of COLD-fX®, says, “Now that COLD-fX is available in the U.S., we are pleased to partner with such an outstanding research center as Hackensack to further build on our commitment to developing evidence-based natural medicines that prevent disease. This trial is important not only to see if COLD-fX® can boost the immune system through different pathways, but also because of its focus on front –line medical workers.”
The trial was reviewed and approved independently by the 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 an Assistant Professor in the Division of Allergy, Immunology and Infectious Diseases, University of Medicine and Dentistry of New Jersey. Dr. Sperber has participated in trials involving category related products like Echinacea and Pseudoephedrine Plus Acetaminophen. He has written in numerous peer reviewed medical journals including: Infections in Medicine and the Journal of the American Medical Association and is a reviewer for six peer reviewed medical journals including the American Journal of Medicine and the American Journal of Infection Control. Dr. Sperber is a fellow of 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 centre adds an average of 100 doctors a year. Hackensack has received the Hospital Award for Clinical Excellence which puts it in the top 5 per cent 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, 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®, 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. All international patents and trademarks are held by fX Life Sciences International GmbH. COLD-fX® is distributed and sold in the U.S. by COLD-fX Pharmaceuticals (USA) Inc. Both companies are wholly-owned subsidiaries of CV Technologies.
This news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results or events to differ materially from the results or events predicted in this discussion, including those comments predicting the timing and/or initiation of clinical trials, clinical trial results and associated regulatory clearances, and the potential success of U.S marketing initiatives and product acceptance in the U.S. 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 or whether clinical trials will produce the anticipated results. Although we believe that the forward-looking statements contained herein are 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 statements within this disclosure will occur, or if they do, that any benefits may be derived from them. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a more in-depth account of risks and uncertainties, please refer to documents filed with the securities regulators on www.sedar.com. The Company assumes no duty to update this disclosure.