VANCOUVER, March 18 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. , a global specialty pharmaceutical and medical device company, announced today that the clinical data from its 960 patient clinical trial comparing its 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC) with a chlorhexidine/silver sulfadiazine (CH-SS) coated CVC was presented by the clinical investigators at the 28th International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels, Belgium. Angiotech believes this study is the largest head-to-head coated CVC clinical trial ever completed.
Based on the clinical trial data, the investigators concluded that Angiotech’s 5-FU CVC met the primary endpoint of the study: non-inferior in its ability to prevent bacterial colonization of the catheter tip when compared to catheters coated with CH-SS. The rate of colonization of the 5-FU CVC was 2.9% (n=12), compared to 5.3% (n=21) in the CH-SS coated catheters (relative reduction in colonization with 5-FU coating of 46%, p=0.055).
There were no statistically significant differences in the rate of adverse events related to the study devices (2.5% for 5-FU vs. 3.1% for CH-SS), or in the rates of catheter-related bloodstream infections (CRBSI), (0% for 5-FU vs. 2.8% for CH-SS). Additionally, there was no evidence for acquired resistance to 5-FU in clinical isolates exposed to the drug for a second time.
As important as the zero rate of catheter-related blood stream infection, the low rate of colonization and the types of organisms implicated are also important. The Angiotech 5-FU coated CVCs were infrequently colonized, and only with S. epidermis and common skin contaminants. In addition to S. epidermis and common skin contaminants, the catheters with CH-SS were also colonized with methicillin-resistant S. aureus, E. coli, K. pneumoniae, P. mirabilis, S. marcescens, and A. baumannii. Both of the blood stream infections in this study were associated with the CH-SS catheter which grew Candida and gram-negative bacteria, pathogens associated with poor patient outcomes. The spectrum of organisms involved will give clinicians reason to choose Angiotech’s 5-FU coated catheter over existing devices.
In addition to meeting the non-inferiority endpoint, these data show a trend toward superiority for the 5-FU coated catheter over the market leading device, both in frequency and nature of colonizations and infections. This efficacy comes without the public health risk that accompanies the long-term, low level exposure to important anti-microbials such as chlorhexidine and silver sulfadiazine or antibiotics like rifampin. Angiotech’s ground breaking 5-FU technology achieves improved anti-infective performance without the risk of clinically meaningful bacterial or fungal resistance, a unique property among anti-infective coatings.
“We are extremely pleased with the clinical results of the 5-FU CVC trial. Achieving zero percent blood stream infection bodes well for a most vulnerable patient population and has very positive implications for the expansion of our 5-FU anti-infective platform. To observe substantial anti-infective performance without exposure to antiseptics or antibiotics is very important to all clinicians, especially infectious disease and infection control experts,” said Dr. William Hunter, President and CEO of Angiotech.
Angiotech submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its 5-FU CVC in December 2007 and is finalising commercialization plans for the product.
About the Study
This study was a multi-center (25 U.S. sites), randomized clinical trial conducted to compare the efficacy of our novel 5-FU-eluting CVC to a CH-SS coated CVC in preventing catheter colonization, local site infection and CRBSI.
About CVC and Catheter-Related Infections
Central venous catheters are usually inserted into critically ill patients for extended periods of time to administer fluids, drugs, and nutrition, as well as facilitate frequent blood draws. One of the complications associated with CVC implantation is infection, which can occur when micro-organisms contaminate the catheter. Catheter related bloodstream infections are estimated to occur at an annual rate of 80,000 to 250,000 cases in the US, resulting in increased mortality, cost, and length of stay.(1-4) The attributable mortality of CRBSI is estimated at 11%.(5) In the U.S., the cost per catheter-related infection can range from $3,700 to $29,000.(6) In addition, the Centers for Disease Control and Prevention (CDC) has raised concerns about the overuse of traditional antibiotics and antiseptics, which can contribute to an increase in bacterial resistance.
About Angiotech’s 5-FU CVC
Angiotech has demonstrated that 5-FU, a well-known and approved compound, has utility to prevent catheter-related infections as effectively as traditional antiseptics and antibiotics. In addition, since 5-FU has no clinical application as either a systemic antibiotic or a hospital antiseptic, there is a reduced risk to the hospital or the community at-large of creating a “super-bug” that may be resistant to useful classes of antibiotics and antispectics and may make infection control more complex. The alarming increase in microbial resistance is one of the CDC’s top concerns.
The principle behind using 5-FU on a CVC is that the drug acts through multiple pathways to inhibit bacterial growth and metabolic functions of most microorganisms. Adding a very minute amount of 5-FU to the surface of a device makes that surface a very hostile environment for a microorganism, with unchanged tolerability for the patient. Our 5-FU technology can also effectively impair biofilm formation that may lead to colonization and infection. This reduction in colonization by bacteria may have a net effect of reducing biofilm burden on the implanted devices, making them less likely to serve as reservoirs for additional infection.
Note on Forward Looking Statements
Statements contained in this press release that are not based on historical fact, including without limitation statements containing the words “believes,” “may,” “plans,” “will,” “estimate,” “continue,” “anticipates,” “intends,” “expects” and similar expressions, constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and constitute “forward-looking information” within the meaning of applicable Canadian securities laws. All such statements are made pursuant to the “safe harbor” provisions of applicable securities legislation. Forward-looking statements may involve, but are not limited to, comments with respect to our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions, both nationally and in the regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; adverse results or unexpected delays in drug discovery and clinical development processes; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to conduct research and development and to expand commercialization activities or consummate acquisitions; the accuracy of our estimations of the size of the market, and the potential market, for our products in specific disease areas; sales numbers and future guidance publicly provided by Boston Scientific Corporation regarding sales of their paclitaxel-eluting coronary stent products; and any other factors that may affect performance. In addition, our business is subject to certain operating risks that may cause the actual results expressed or implied by the forward-looking statements in this report to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete preclinical and clinical development of our products; changes in business strategy or development plans; our failure to obtain patent protection for discoveries; loss of patent protection resulting from third party challenges to our patents; commercialization limitations imposed by patents owned or controlled by third parties; our ability to obtain rights to technology from licensors; liability for patent claims and other claims asserted against us; our ability to obtain and enforce timely patent and other intellectual property protection for our technology and products; the ability to enter into, and to maintain, corporate alliances relating to the development and commercialization of our technology and products; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the ability of Boston Scientific Corporation to successfully manufacture, market and sell their paclitaxel-eluting coronary stent products; the continued availability of capital to finance our activities; our ability to achieve the financial benefits expected as a result of the acquisition of American Medical Instruments Holdings, Inc. (“AMI”); and any other factors referenced in our annual information form and other filings with the applicable Canadian securities regulatory authorities or the SEC. Given these uncertainties, assumptions and risk factors, readers are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained in this press release to reflect future results, events or developments.
About Angiotech
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech , please visit our website at www.angiotech.com.
CONTACT: Deirdre Neary, Angiotech Pharmaceuticals, Inc., (604) 222-7056, dneary@angio.com
CONTACT: Deirdre Neary, Angiotech Pharmaceuticals, Inc., (604) 222-7056,
dneary@angio.com
