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 enrollment 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.
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, [email protected]
SOURCE Angiotech Pharmaceuticals, Inc.