VANCOUVER, April 21 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals,
Inc. (NASDAQ: ANPI, TSX: 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: ANPI, TSX: ANP),
please visit our website at www.angiotech.com.
CONTACT: Deirdre Neary, Manager, Investor Relations, Angiotech
Pharmaceuticals, Inc., (604) 222-7056, dneary@angio.com
SOURCE Angiotech Pharmaceuticals, Inc.
Deirdre Neary, Manager, Investor Relations, Angiotech Pharmaceuticals, Inc.,
(604) 222-7056, dneary@angio.com
