Angiotech Completes Enrolment In Its Central Venous Catheter (CVC) Pivotal Study
Angiotech Pharmaceuticals,
Inc. (NASDAQ: ANPI, TSX: ANP), a far-reaching specialty pharmaceutical and
medical device company, today announced the completion of enrolment in its
Median Venous Catheter (CVC) Pivotal Study, which is designed to examine
the safety and efficacy of Angiotech’s 5-Fluorouracil (5-FU) coated CVC in
preventing bacterial catheter colonization when compared to another leading
anti-infective CVC.
“The 5-FU ‘anti-infective’ CVC is a unrivalled illustration of what we
envisioned Angiotech would be capable 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 progress process, and will be promoted and
distributed through our own marketing and sales effective. 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 mark of cadency portfolio,” said Dr. William Hunter, President and CEO of
Angiotech.
Prime venous catheters (CVC) are usually inserted into critically suffering
patients for extended periods of time to administer fluids, drugs, and
nutrition, as well as facilitate frequent blood draws. An individual 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.
Almost 3.5 million CVC’s are second-hand in the U.S. annually leading
to give 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 nearby the overuse of traditional
antibiotics, which can aid to an burgeon in the antibiotic
defences underground 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 bring in effect
of reducing biofilm onus on the implanted catheters, making them less
undoubtedly to serve as reservoirs for additional infection. 5-FU has also been
shown to interfere with the expansion of a digit of bacterial species
straight away which may be a second source of efficacy in preventing
catheter-based infections.
“An additional important benefit is that not sole does the 5-FU coating
have the capability to abort catheter-associated infections as ooze as
old antiseptics and antibiotics, but since 5-FU has no clinical
practice as either a systemic antibiotic or a sanatorium 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 rule more complex,” added Dr. Hunter.
Angiotech expects to have preliminary data results compiled in the
fall, and immediate the conclusive figures results in at the crack 2008 at a major
scientific symposium. Pending trial results and all necessary approvals,
Angiotech will prepare to launch the commercial artefact line in 2008.
About the CVC Pivotal Trial
The CVC trial is a randomized, celibate-insensitive, active-controlled,
two-arm, multi-center clinical study. The primary fair of the study is
to merit comparison with the Angiotech 5-FU coated CVC to a chief anti-infective
catheter with regards to preventing bacterial colonization. The ponder will
enrol at reduced 790 evaluable subjects at up to 25 investigative sites
located in the United States.
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Forth 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 ploy implants, surgical
interventions and on the qui vive maltreatment. To find gone away from more about Angiotech (NASDAQ:
ANPI, TSX: ANP), see fit visit our website at http://www.angiotech.com.
Angiotech Pharmaceuticals, Inc.
http://www.angiotech.com
Jose Burden