Bioenvision's OLIGON Technology Found to Significantly Reduce Catheter-Related Infection.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--July 17, 2003 Four-Year Observational Study In statistics, the goal of an observational study is to draw inferences about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator. Shows Extremely Low Infection Rate When Using OLIGON Bioenvision, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BIOV) today announced results of a four-year observational study of its OLIGON(R) anti-infective technology for the reduction of catheter-related infection. The study was conducted by Dr. Shaikh, Director of Critical Care at Frimley Park Hospital Frimley Park Hospital is a large, 700-bed NHS hospital in Frimley, Surrey, part of the Frimley Park Hospital NHS Foundation Trust. It opened in 1974 to provide a full range of district general hospital services for North East Hampshire and West Surrey, a catchment NHS Trust National Health Service Trusts (NHS Trusts) provide many services of the National Health Service in England and Wales. They are not trusts in the legal sense but are in effect public sector corporations. in the U.K., and the results had been presented previously at international critical care conferences in Europe and the U.S. The study revealed that the introduction of the OLIGON material was associated with a significant reduction in blood stream infections. In the 2,482 patient study, those receiving OLIGON-coated central venous catheters central venous catheter n. A catheter passed through a peripheral vein and ending in the thoracic vena cava; it is used to measure venous pressure or to infuse concentrated solutions. showed only a 0.16% infection rate, compared to a 4% when using traditional chlorhexidine-coated catheters. In addition, the OLIGON catheters were left in for a mean duration of 8.1 days compared to 6.1 days for chlorhexidine chlorhexidine /chlor·hex·i·dine/ (klor-heks´i-den) an antibacterial effective against a wide variety of gram-negative and gram-positive organisms; used also as the acetate ester, as a preservative for eyedrops, and as the gluconate or catheters. "The results of this study clearly indicate the effectiveness of OLIGON in preventing catheter-related infections," said Dr. Christopher Dr. John R. Christopher, known popularly as "Dr. Christopher" was one of very few nationally prominent doctors of herbal medicine of the middle third of the 20th century, a "dark ages" of herbalism and was responsible for the herbal renaissance of the 1960s. B. Wood, Chairman and Chief Executive Officer of Bioenvision. "The numbers are significant and very impressive. Using the OLIGON material, infection rates decreased by over 95% compared to traditional catheters." The OLIGON technology is also effective against antibiotic-resistant bacteria. Doctors performing the study have reported that they are now confident to leave OLIGON catheters in for up to 31 days. This significant improvement will reduce patient discomfort associated with repeated line changes and will reduce costs as well. "Our anti-infective technology platform provides value and diversity to Bioenvision, which is primarily oncology-focused," continued Dr. Wood. "OLIGON has proven itself highly effective and provides significant out-licensing opportunities for Bioenvision." Central venous catheters (CVCs) are very important for the treatment of critically ill patients, however they account for nearly 90% of bloodstream infections originating in the hospital (nosocomial nosocomial /noso·co·mi·al/ (nos?o-ko´me-il) pertaining to or originating in a hospital. nos·o·co·mi·al adj. 1. Of or relating to a hospital. 2. bloodstream infections). On average, 5% of the short-term CVCs inserted in the U.S. lead to bloodstream infections, totaling approximately 150,000 cases annually. In addition to increased morbidity and mortality Morbidity and Mortality can refer to:
About OLIGON Bioenvision's OLIGON technology involves the impregnation impregnation /im·preg·na·tion/ (im?preg-na´shun) 1. fertilization. 2. saturation (1). impregnation 1. the act of fertilizing or rendering pregnant. 2. saturation. of a polymer material with silver, platinum and carbon particles. Upon contact with an ionic solution such as saline, medications or body fluids, an electrochemical electrochemical /elec·tro·chem·i·cal/ (-kem´i-k'l) pertaining to interaction or interconversion of chemical and electrical energies. e·lec·tro·chem·i·cal adj. reaction between the silver and platinum particles is activated, and silver ions are actively released to the surface of the polymer and then into its immediate surrounding environment. Silver has been used for decades as an antimicrobial agent and are virtually harmless to the body. The silver ions destroy bacteria, fungi and even antibiotic-resistant microbes on the entire device surface, both inside and outside, and in the immediately surrounding environment over extended periods of time. OLIGON has been approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for inclusion in two commercialized catheters, for which Bioenvision is receiving royalties based on sales. Bioenvision has received approval to use OLIGON in a third commercial product and is currently considering other devices as well. About Bioenvision Bioenvision's (OTCBB: BIOV.OB) primary focus is the acquisition, development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: clofarabine (in co-development with ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. Oncology, Inc.); Modrenal(R) (for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of advanced post-menopausal breast cancer); and other products in clinical trials. For more information on Bioenvision please visit our Web site at www.bioenvision.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements. |
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