Angiotech completes enrolment in its Central Venous Catheter (CVC) Pivotal Study
10 Juli 2007 - 10:15PM
PR Newswire (US)
VANCOUVER, July 10 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, today
announced the completion of enrolment in its Central 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 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. 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," "could", "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 objectives and priorities
for 2007 and beyond, our strategies or future actions, our targets,
our estimation of potential market size, expectations for our
financial condition and the results of, or outlook for, our
operations, research development and further product and drug
development. Such forward-looking statements also 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. Such 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; technological
changes that impact our existing products or our ability to develop
and commercialize future products; competition; changes in business
strategy or development plans; the ability to attract and retain
qualified personnel; 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; 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; dependence upon, and
relationships with strategic alliance partners to develop and
commercialize products and services based on our work; our ability
to obtain rights to technology from licensors; liability for patent
claims and other claims asserted against us; the requirement for
substantial funding to conduct research and development and to
expand commercialization activities or consummate acquisitions; the
size of the market and the potential market for our products in
specific disease areas, other factors referenced in our annual
information form and other filings with the applicable Canadian
securities regulatory authorities or the Securities and Exchange
Commission; 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
successfully complete preclinical and clinical development of our
products; the ability to obtain and enforce timely patent and other
intellectual property protection for our technology and products;
decisions, and the timing of decisions, made by health regulatory
agencies regarding approval of our technology and products; the
ability to complete and maintain corporate alliances relating to
the development and commercialization of our technology and
products; market acceptance of our technology and products; the
competitive environment and impact of technological change; the
continued availability of capital to finance our activities; our
ability to integrate into our business the operations of AMI; and,
our ability to achieve the operational and other synergies and the
other commercial or financial benefits expected as a result of the
acquisition of AMI. 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 report 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
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. CONTACT: Janet Craig, VP, Investor
Relations and Corporate Communications, Angiotech Pharmaceuticals,
Inc., (604) 221-6933, ; Jodi Regts, Manager, Investor Relations and
Corporate Communications, Angiotech Pharmaceuticals, Inc., (604)
221-7930, DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT:
Janet Craig, VP, Investor Relations and Corporate Communications,
Angiotech Pharmaceuticals, Inc., (604) 221-6933, ; Jodi Regts,
Manager, Investor Relations and Corporate Communications, Angiotech
Pharmaceuticals, Inc., (604) 221-7930,
Copyright
Angiotech Pharmaceuticals - Common Shares (MM) (NASDAQ:ANPI)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
Angiotech Pharmaceuticals - Common Shares (MM) (NASDAQ:ANPI)
Historical Stock Chart
Von Jul 2023 bis Jul 2024