Angiotech announces positive results from Bio-Seal(TM) clinical study
10 März 2009 - 1:30AM
PR Newswire (US)
VANCOUVER, March 9 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) today
announced positive clinical study results for its Bio-Seal(TM) Lung
Biopsy Tract Plug System at the Society of Interventional
Radiologists Annual Scientific Meeting in San Diego, CA. The trial
assessed the safety and efficacy of Bio-Seal in patients undergoing
lung biopsy procedures and demonstrated a statistically significant
clinical benefit in the group receiving BioSeal. "We are extremely
pleased that the Bio-Seal treatment arm hit the primary end point
of clinical success," said Dr. William Hunter, President and CEO of
Angiotech. "These results indicate that Bio-Seal improves the
existing technology used to diagnose lung cancer by significantly
reducing the rates of pneumothorax." The purpose of this clinical
study was to assess the safety and efficacy of an expanding
hydrogel plug in reducing pneumothorax rates associated with
CT-guided lung biopsy. The prospective, randomized, controlled
clinical study enrolled and randomized 339 investigational patients
at 15 different investigational sites. Inspiratory upright chest
x-rays were performed at 30 to 60 minutes, 24 hours and 30 days
after treatment. The Bio-Seal treatment arm hit the primary end
point of clinical success, absence of pneumothorax at each time
period. Based on the per-protocol population, clinical success rate
was 85% using Bio-Seal and 69% in the control group. This
difference was statistically significant (p=0.002). Although not
powered for statistical analysis, positive trends were also
observed for Bio-Seal subjects as compared to the control group in
various secondary endpoints, including fewer Bio-Seal subjects
admitted to the hospital for pneumothoraces (9.4% vs. 13.6%), fewer
chest tubes placements in Bio-Seal patients (3.5% vs. 10.7%), and
fewer additional chest x-rays required in Bio-Seal patients (0.6%
vs. 5.3%). Angiotech is the worldwide manufacturer and distributor
of the Bio-Seal Lung Biopsy Tract Plug System, which has already
received CE Mark approval and is currently marketed and sold in the
EU. About BioSeal(TM) Lung Biopsy Tract Plug System Bio-Seal is a
novel technology designed to reduce the incidence of post-operative
pneumothorax (collapsed lung) in patients who undergo lung biopsy
procedures. The technology involves the placement of an expanding
hydrogel plug along the biopsy needle track during the procedure,
closing off the track to subsequent influx of air into the chest
during respiration after the biopsy needle is withdrawn. The seal
is airtight and the plug is absorbed into the body after healing of
the puncture site has occurred. 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," "estimates," "continues," "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 "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 2009 and beyond, our
strategies or future actions, our targets, expectations for our
financial condition and the results of, or outlook for, our
operations, research, development, 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 pre-clinical
and clinical product development processes; adverse findings
related to the safety and/or efficacy of our products or products
sold by our partners; 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 manufacturing and
commercialization activities or consummate acquisitions; 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 press release to differ materially from our
actual results. These operating risks include: our ability to
attract and retain qualified personnel; our ability to successfully
complete pre-clinical 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 continued
availability of capital to finance our activities; and any other
factors referenced in our other filings with the Securities and
Exchange Commission ("SEC") and applicable Canadian regulatory
authorities. For a more thorough discussion of the risks associated
with our business, see the "Risk Factors" section in our annual
report for the year ended December 31, 2007 filed with the SEC on
Form 40-F and our quarterly report for the three months ended
September 30, 2008 filed with the SEC on Form 10-Q. Given these
uncertainties, assumptions and risk factors, readers are cautioned
not to place undue reliance on such forward-looking statements.
Except as required by law, 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. (C)2009
Angiotech Pharmaceuticals, Inc. All Rights Reserved. Bio-Seal(TM)
is a trademark of Medical Device Technologies, Inc., a wholly-owned
subsidiary of Angiotech Pharmaceuticals, Inc. 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/. DATASOURCE: Angiotech Pharmaceuticals,
Inc. CONTACT: DeDe Sheel, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412,
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