Angiotech elects to suspend Vascular Wrap(TM) pivotal clinical trials
21 April 2008 - 3:00PM
PR Newswire (US)
VANCOUVER, April 21 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, today
announced that it has elected to suspend enrolment in its U.S. and
EU human clinical trials for its Vascular Wrap product candidate in
patients undergoing surgery for hemodialysis access, pending a
safety review to evaluate an imbalance of infections that have been
observed between the two study groups. The U.S. and EU trials each
consist of two study groups; (1) patients who received the
graft/Vascular Wrap combination; and, (2) patients who received the
graft alone. At the onset of this study Angiotech established an
independent Data Safety Monitoring Board (DSMB) in the U.S. to
monitor any unexpected risks or safety issues. Angiotech recently
submitted a safety summary of adverse events from the U.S. clinical
trial to the DSMB, based upon having reached the 25% enrolment
threshold in the U.S. clinical trial. Subsequent to that
submission, Angiotech received a communication from the DSMB that
one of the study groups had a greater incidence of implant site
infection in comparison with the other study group. Angiotech is
blinded to the groups and not currently aware of whether the
increased rate of infection is in the patient group that received
the graft/Vascular Wrap combination or in the patient group that
received the graft alone. As a result of these observations,
Angiotech has elected to notify physicians to suspend further
enrolment in the trials, pending a full review of the potential
cause of the implant site infections. "We regard patient safety as
the paramount obligation of any company in our industry, and upon
further adjudication of the clinical data, we hope to identify the
underlying cause of these observed events, and to make a prudent
and sensible decision regarding the future of this clinical
development program," said Dr. Jeff Walker, Chief Scientific
Officer of Angiotech. Angiotech is conducting a detailed analysis
that seeks to determine the root cause of the imbalance between the
two study groups, and will work with its Clinical Events Committee,
the DSMB, the Medicines and Healthcare products Regulatory Agency,
and the U.S. Food and Drug Administration to make near term
decisions about the continuation of the trials. 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," "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 strategies or
future actions, our targets, expectations for our financial
condition and the results of, or outlook for, our operations,
research development and 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 drug discovery
and clinical development processes; 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
commercialization activities or consummate acquisitions; the
accuracy of our estimations of the size of the market, and the
potential market, for our products in specific disease areas; sales
numbers and future guidance publicly provided by Boston Scientific
Corporation regarding sales of their paclitaxel-eluting coronary
stent products; 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
attract and retain qualified personnel; our ability to successfully
complete preclinical 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 ability of Boston
Scientific Corporation to successfully manufacture, market and sell
their paclitaxel-eluting coronary stent products; the continued
availability of capital to finance our activities; our ability to
achieve the financial benefits expected as a result of the
acquisition of American Medical Instruments Holdings, Inc.; and any
other factors referenced in our annual information form and other
filings with the applicable Canadian securities regulatory
authorities or the Securities and Exchange Commission. 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 press release to reflect future
results, events or developments. Vascular Wrap(TM) is a trademark
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/. CONTACT: Deirdre
Neary, Manager, Investor Relations, Angiotech Pharmaceuticals,
Inc., (604) 222-7056, DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: Deirdre Neary, Manager, Investor Relations, Angiotech
Pharmaceuticals, Inc., (604) 222-7056,
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