European trial explores treating renal artery blockages with a balloon expandable paclitaxel-eluting renal stent
VANCOUVER, April 21 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced Cook Medical, a license holder of Angiotech's paclitaxel technology, has enrolled the first patient in its landmark Formula(TM) PTX(R) clinical trial. The trial is the first of its kind to evaluate the safety and effectiveness of a paclitaxel-eluting stent to treat renal artery disease, the narrowing of the arteries that supply blood to the kidneys. The multi-center, randomized trial plans to enroll 120 patients at sites across Europe. The trial utilizes Cook's Formula Renal Stent, which is designed with a very low profile that may help it cross tightly blocked vessels for placement into diseased renal arteries.
"Following Cook Medical's success with the Zilver PTX, we chose to be involved in the clinical trial for the Formula PTX Balloon Expandable Renal Stent," said Professor Dierk Scheinert, Angiology and Cardiology Specialist at participating hospital, Park-Krankenhaus Leipzig-South. "Given the early success of the US REFORM clinical trial evaluating the Formula Balloon Expandable Stent, we remain very excited about the potential of a drug-eluting renal stent. Providing physicians with a greater range of devices will ultimately help patients receive the best possible treatment options."
About Renal Artery Disease
Renal artery disease is a narrowing of the arteries that supply blood to the kidneys. Plaque (fatty deposits and calcium) can collect within these arteries, reducing blood flow to the kidneys. The kidneys may then send signals to the body for more blood, increasing your blood pressure. This high blood pressure, coupled with the atherosclerosis, greatly increases stress on the heart, and could also lead to a stroke. The restriction of blood flow from the renal artery can also decrease the ability of the kidneys to filter and remove the waste and fluids from the body, leading to possible renal insufficiency and kidney failure.
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 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 objectives and priorities for the remainder of 2010 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and 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 known 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 in the United States, Canada and the other 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 legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; 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, to expand manufacturing and commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any 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 our 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 availability of capital to finance our activities; our ability to restructure and to service our debt obligations; and any other factors referenced in our other filings with the applicable Canadian securities regulatory authorities or the Securities and Exchange Commission ("SEC"). 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, 2009 filed with the SEC on Form 10-K.
Given these uncertainties, assumptions and risk factors, investors 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) 2010 Angiotech Pharmaceuticals, Inc. All Rights Reserved.
About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company. 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.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com.
SOURCE Angiotech Pharmaceuticals, Inc.
For further information: For further information: Rick Smith, Angiotech Pharmaceuticals, Inc., (604) 221-6933, email@example.com