Angiotech Completes Enrolment In Its Central Venous Catheter (CVC) Pivotal Study
"The 5-FU 'anti-infective' CVC is a leading example of what we envisioned Angiotech would be able to accomplish as a fully integrated company. This is the first product that originated from our in-house drug screening and discovery efforts, progressed through our own internal clinical and regulatory development process, and will be promoted and distributed through our own marketing and sales force. In addition, since biofilm development and implant infection is a ubiquitous problem with medical devices, this technology could also provide the basis to develop drug-coated versions of other commercial products within our existing medical device portfolio," said Dr. William Hunter, President and CEO of Angiotech.
Central venous catheters (CVC) 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 bacteria contaminate the catheter. CVC infections that progress to bloodstream infections, or septicemia, can become life threatening.
Approximately 3.5 million CVC's are used in the U.S. annually leading to approximately 250,000 CVC-related infections and an estimated 40,000 deaths. The cost of caring for these patients is estimated to be as high as US $56,000 per infection. In addition, the Centers for Disease Control and Prevention (CDC) has raised concerns about the overuse of traditional antibiotics, which can contribute to an increase in the antibiotic resistance of bacteria.
The principle behind using 5-FU - an approved anti-cancer drug - is that the drug appears to effectively interrupt the colonization of an implanted medical device by those micro-organisms that typically gain entrance to the bloodstream via the local skin penetration of implanted catheters. This reduction in colonization by bacteria may have a net effect of reducing biofilm burden on the implanted catheters, making them less likely to serve as reservoirs for additional infection. 5-FU has also been shown to inhibit the proliferation of a number of bacterial species directly which may be a second source of efficacy in preventing catheter-based infections.
"An additional important benefit is that not only does the 5-FU coating have the potential to prevent catheter-related infections as well as traditional antiseptics and antibiotics, but since 5-FU has no clinical application as either a systemic antibiotic or a hospital antiseptic, there is little risk to the hospital or the community at-large of creating a 'super-bug' that is resistant to a useful class of antibiotic and can make infection control more complex," added Dr. Hunter.
Angiotech expects to have preliminary data results compiled in the fall, and present the final data results in early 2008 at a major scientific symposium. Pending trial results and all necessary approvals, Angiotech will prepare to launch the commercial product line in 2008.
About the CVC Pivotal Trial
The CVC trial is a randomized, single-blind, active-controlled, two-arm, multi-center clinical study. The primary objective of the study is to compare the Angiotech 5-FU coated CVC to a leading anti-infective catheter with regards to preventing bacterial colonization. The study will enrol at minimum 790 evaluable subjects at up to 25 investigative sites located in the United States.
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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 (NASDAQ: ANPI, TSX: ANP), please visit our website at http://www.angiotech.com.
Angiotech Pharmaceuticals, Inc.
http://www.angiotech.com
Angiotech completeaza sale de înscriere în cateter venos central (CVC)-un studiu pivot - Angiotech Completes Enrolment In Its Central Venous Catheter (CVC) Pivotal Study - articole medicale engleza - startsanatate