Angiotech Initiates Anti-Infective CVC U.S. Pivotal Study
ADVANCING NOVEL APPROACH TO PREVENT MEDICAL DEVICE INFECTIONS
VANCOUVER, Jan. 5 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI,
TSX: ANP) today announced the initiation of its United States pivotal study
examining an anti-microbial central venous catheter (CVC). This U.S.
multi-center study is designed to evaluate the efficacy of a CVC coated with
the drug 5-Flourouracil (5-FU), a non-traditional anti-infective agent. The
study enrolled its first patient last week in Rapid City, South Dakota, and
will involve approximately 600 patients at 20 centers in the United States.
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 bacteria contaminate the catheter. CVC infections that progress to
bloodstream infections, or septicemia, can become life threatening.
Approximately 3.5 million CVC catheters 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.
Angiotech is developing its infection prevention platform using the drug
5-FU as a non-traditional anti-infective in order to address concerns voiced
by the Centers for Disease Control (CDC) regarding overuse of traditional
antibiotics, which can contribute to an increase in the antibiotic resistance
of bacteria. Traditional anti-infective coatings are being used more
frequently each year, and are currently used on approximately 20 percent of
CVC products implanted.
“We are excited to be participating in a study addressing such a
pervasive and critical issue,” said Jorge Reyno, MD, an infectious disease
specialist at Rapid City Regional Hospital in South Dakota where the first
patient was recently enrolled. “Hospital-based infections, which include CVC
infections, are a vexing and potentially lethal problem that demands a better
solution.”
“The use of 5-FU as an anti-infective coating to prevent catheter-related
bloodstream infections is innovative and unique,” said Stephen Heard, MD,
Chair, Department of Anesthesiology at University of Massachusetts Memorial
Medical Center and the University of Massachusetts Medical School, and
principal investigator. “(In vitro) data demonstrate that 5-FU has
antibacterial activity similar to current anti-infective catheter surfaces. We
are eager to see if these effects impact catheter colonization and bloodstream
infection in patients.”
“Two million patients contract hospital-based infections in the U.S. each
year,” said Betsy McCaughey, Ph.D, Chairman of the Committee to Reduce
Infection Deaths (RID). “RID applauds the efforts of innovative pharmaceutical
companies to reduce catheter-based infections.”
About the Anti-Infective CVC Trial:
The CVC trial is a randomized, single-blind, active-controlled, two-arm,
multi-center clinical study. The lead trial site is the University of
Massachusetts Memorial Medical Center, with Dr. Stephen Heard as principal
investigator. The primary objective of the study is to compare the Angiotech
CVC catheter to a leading anti-infective catheter with regards to preventing
bacterial colonization. Other objectives will include prevention of local
catheter-related infections or widespread bloodstream infections. Following
favorable study results, the company intends to request 510k market clearance
for the product from the U.S. Food and Drug Administration.
About the Angiotech Anti-Infective CVC Technology:
Due to the emergence of antibiotic-resistant bacteria, the CDC has
discouraged overuse of traditional antibiotics to help avoid the creation of
resistant strains and has encouraged the search for alternative anti-infective
strategies.
Angiotech is actively developing a broad anti-infective platform using
non-traditional agents found through its proprietary drug screening process.
This process consists of screening thousands of approved pharmaceutical
compounds and discovering non-traditional applications for their use in local
drug delivery in combination with medical devices and biomaterials. Through
this proprietary drug identification strategy, Angiotech has chosen 5-FU as
its lead compound, an FDA approved drug. Some of the advantages of 5-FU
include: 1) the ability to kill bacteria such as gram positive Staphylococcus
aureus and gram negative Pseudomonas aeruginosa, which can be lethal
pathogens, 2) the unique and valuable ability to help prevent formation of
biofilm, a slimy coating that bacteria produce to protect them from
traditional antibiotics, and 3) the fact that it doesn’t contribute to
bacterial resistance against traditional antibiotics.
About RID:
The Committee to Reduce Infection Deaths (RID) is a national
organization, founded by Betsy McCaughey, Ph.D., dedicated to providing
hospital administrators, caregivers, insurers, and patients with the
information they need to stop hospital infections. RID’s mission is threefold:
to motivate hospitals to make infection prevention a top priority; to inform
patients about the steps they can take to reduce their risk of infection; and
to ensure that no matter where you live, you can find out which hospitals in
your area have the worst infection problems. The Committee has a distinguished
membership, including Yale Professor, Dr. Sherwin Nuland, author of The
Doctor’s Plague, a biography of Ignac Semmelweis, Dr. Elizabeth Whelan,
founder of the American Council on Science and Health, and Nobel Laureate,
Dr. Joshua Lederberg, as well as corporate leaders, philanthropists, and civic
leaders. To find out more about RID, please visit their website at
http://www.hospitalinfection.org.
About Angiotech Pharmaceuticals
Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty
pharmaceutical company pioneering the combination of pharmaceutical compounds
with medical devices and biomaterials to both create novel solutions for
poorly addressed disease states and improve surgical outcomes. To find out
more about Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), please
visit our website at www.angiotech.com.
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fact, including without limitation statements containing the words
“anticipates,” “believes,” “may,” “continue,” “estimate,” “expects,” and
“will” and words of similar import, constitute “forward-looking statements”
within the meaning of the U.S. Private Securities Litigation Reform Act of
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developments to be materially different from any future results, events or
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technology changes; competition; changes in business strategy or development
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regulators. Given these uncertainties, readers are cautioned not to place
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For further information: Analysts and Investors: Todd Young, Vice
President Investor Relations and Communications, Angiotech Pharmaceuticals,
Inc., (604) 221-7676 ext 6933; Analysts: Rui Avelar, Chief Medical Officer,
Angiotech Pharmaceuticals, Inc., (604) 221-7676 ext 6996; Media: Colleen
Beauregard, Waggener Edstrom Bioscience, (503) 443-7863, Email:
colleenb@wagged.com
