CV Technologies Inc. today announced that COLD-FX® will be the focus of a landmark U.S. National Cancer Institute (NCI) sponsored trial involving chronic lymphocytic leukemia patients – the first time the natural medicine will be part of a clinical study associated with cancer. The NCI, part of the U.S. National Institutes of Health, is the world’s most prestigious cancer research body. The trial will be conducted by American cancer and infectious diseases experts at Wake Forest University School of Medicine in Winston-Salem, North Carolina.
The double-blind, placebo-controlled trial, involving more than 300 patients, was originally planned to include up to 100 U.S. research sites. However, in approving the study, the NCI accelerated the process – targeting completion over a single cold and flu season. To assist in recruitment, it also opened up its cancer trials support unit network of more than 1,500 cancer research sites across the United States. Most of the clinical trial costs will be funded by the NCI, with CV Technologies providing comparatively minor grant funding.
The impetus for the COLD-FX trial came from two prominent researchers at Wake Forest University School of Medicine: Principal Investigator Dr. Kevin High, Chief of Infectious Diseases and Professor of Medicine in the Sections on Infectious Diseases, Hematology/ Oncology and Molecular Medicine; and Dr. Edward Shaw, Principal Investigator of Wake Forest’s Community Clinical Oncology Program Research Base. They will coordinate a broad network of cancer specialists involved in the study.
Dr. High says: “Chronic lymphocytic leukemia is a common and chronic condition that primarily afflicts older adults aged 60 and over. The risk of respiratory infections is greatly enhanced in these patients because of immune dysfunction that accompanies the disease, and is worsened by current treatments. The weakened immune system means vaccines don't work as well in these patients so alternate means of preventing infection are an urgent need. The Healthcare Cost and Utilization Project reported that hospital costs in the U.S. for chronic lymphocytic leukemia patients alone amounted to $125 million in 2000."
Wake Forest is currently conducting approximately 150 cancer trials and is regarded as one of America’s leading cancer research facilities according to an annual ranking by U.S. News and World Report.
Dr. Shaw says: “The COLD-FX study is the most important clinical trial of the many utilizing a botanical or natural product that the Wake Forest Community Clinical Oncology Program Research Base has conducted in its 10-year history”.
“We are very excited about COLD-FX’s potential to help cancer patients since colds and flu and other infections can be very significant problems for them, including people suffering from chronic lymphocytic leukemia,” says Dr. Jacqueline Shan, President and Chief Scientific Officer of CV Technologies. “Rigorously designed clinical trials like the Wake Forest study are necessary to determine COLD-FX’s effectiveness before it can be recommended to cancer patients. We are pleased that so many outstanding researchers and organizations believe in the merits of COLD-FX’s existing research."
Participants will take 400 milligrams of COLD-FX per day or a placebo over the 2008/2009 cold and flu season. The trial will examine COLD-FX’s effectiveness in preventing acute respiratory infections and reducing antibiotic use during the three-month period from January to April 2009. The researchers will also study the duration and severity of acute respiratory infections, all other incidences of infection, antibiotic utilization, chronic lymphocytic leukemia disease activity, and parameters related to immune health.
The National Cancer Institute says on its website that this trial is important because both the cancer and its treatment, “…can impair immune system functioning and markedly increase risk of infection, the most common complication…” of chronic lymphocytic leukemia.
Regarding past COLD-FX research the NCI website says, “Two randomized, controlled trials have shown that an extract of North American Ginseng, called CVT-E002 (COLD-FX), can significantly reduce the risk of ARI [acute respiratory infection] in older adults”.
Dr. High says, “Our hypothesis – that COLD-FX could reduce infections by enhancing immune function in chronic lymphocytic leukemia patients – is supported by previous research. There are encouraging results from studies that, importantly, involved older adults, including trials that demonstrated safety and effectiveness in seniors in nursing homes. These were conducted by Dr. Janet McElhaney, an influenza expert and Division Head, Geriatric Medicine at the University of British Columbia and Providence Health Care. Like chronic lymphocytic leukemia patients, residents of nursing homes often have multiple chronic conditions and are at high risk for respiratory infection. As well, promising research has been done by cancer researcher Dr. Sandra Miller of the Department of Anatomy and Biology in the Faculty of Medicine of Montreal’s McGill University." The Canadian National Research Council-sponsored study by Dr. Miller showed that COLD-FX administered to mice with leukemia helped return their immune systems to normal levels and improved their lifespans significantly.
Dr. Miller said, “COLD-FX stimulates anti-cancer and anti-viral immunity in mice. It is therefore an excellent candidate for testing in human patients. It is very different from other ginseng-derived products and is uniquely comprised of a single active class of molecules extracted from the plant: a specific type of polysaccharides."
ABOUT DR. KEVIN HIGH
Kevin P. High, MD, MS, FACP is Chief, Section on Infectious Diseases, as well as Professor of Medicine, Sections on Infectious Diseases, Hematology and Oncology, and Molecular Medicine. He is Co-Director of the Molecular Medicine Graduate Program and Director of the General Clinical Research Center (GCRC) at Wake Forest University School of Medicine in Winston-Salem, North Carolina, where he has held various academic positions since 1993. He also serves as an attending physician at Wake Forest University Baptist Medical Center. He is a member of several editorial boards, including Journal of the American Geriatrics Society (Section Editor) and Clinical Infectious Diseases (Section Editor) and has written or co-authored articles that have appeared in more than 50 peer-reviewed medical publications.
ABOUT DR. EDWARD SHAW
Edward Shaw, M.D., is Principal of the Comprehensive Cancer Center of Wake Forest University Community Clinical Oncology Program Research Base. The Wake Forest Research Base is a NCI-funded entity that offers clinical trials in symptom management and quality of life in cancer patients. It has 24 participating Community Clinical Oncology Programs comprising more than 100 community cancer centers across the Midwest and Eastern United States. Dr. Shaw’s main areas of research interest include botanical/natural product clinical trials and symptom management/quality of life studies in cancer patients. Over the last 25 years, he has been principal investigator or co-investigator on 50 oncology studies, which have accrued approximately 3,000 patients. Dr. Shaw, a professor in the Department of Radiation Oncology at Wake Forest, has written or co-authored 130 peer-reviewed journal articles and 50 book chapters.
ABOUT THE NATIONAL CANCER INSTITUTE
The National Cancer Institute has been engaged in research since it was founded in 1937 and is a division of the U.S. National Institutes of Health. It is the world’s pre-eminent cancer research organization and has supported the research efforts of least 20 Nobel Prize winners.
CANCER PATIENTS’ IMMUNE SYSTEMS
In healthy humans, the primary defense against infection is white blood cells in the immune system. Chronic lymphocytic leukemia is a chronic illness that often does not require aggressive chemotherapy or radiation, but the leukemia itself reduces immune function of the white blood cells and the risk of infection, particularly respiratory infections, is greatly increased.
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 this U.S. National Cancer Institute sponsored clinical trial involving chronic lymphocytic leukemia patients, 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: general economic conditions and the risk that clinical trials may not demonstrate the safety and efficacy expected or 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 news release 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. .
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