Angiotech Announces That Cook Medical's Zilver Ptx Drug-Eluting Stent Meets Its Primary Endpoint In A 479-Patient, Multi-Center, Pivotal Clinical Triala
FINAL CLINICAL STUDY DATA PRESENTED TODAY BY DR. MICHAEL DAKE AT THE TRANSCATHETER CARDIOVASCUALR THERAPEUTICS (TCT) CONFERENCE IN WASHINGTON, DC
VANCOUVER, Sept. 24 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that a summary of the final clinical trial results for the randomized study of Cook Medical's Zilver(R) PTX(R) Drug-Eluting Peripheral Stent for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) was presented today at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington D.C. The study - from the largest clinical trial to ever evaluate the performance of a drug-eluting stent (DES) in the treatment of peripheral vascular disease - met its 12-month primary endpoint goals showing non-inferior event-free survival (EFS) and superior patency for the Zilver PTX as compared to balloon angioplasty. Cook Medical, a license holder of Angiotech's paclitaxel technology, has developed Zilver PTX: a self-expanding, highly durable nitinol stent that uses a proprietary technology to deliver a locally therapeutic dose of paclitaxel, a proven anti-restenotic drug, to the target lesion. The data from this clinical trial supports Cook's PMA application submitted to the FDA earlier this year.
This multicenter, multinational, prospective, randomized study compared the safety and effectiveness of the Zilver PTX to balloon angioplasty and bare metal stenting. Patients with de novo or restenotic SFA lesions were randomized to balloon angioplasty or Zilver PTX stent placement. Balloon angioplasty patients experiencing acute failure ((greater than) 30% residual stenosis) underwent secondary randomization to provisional stenting with Zilver BMS (bare metal stent) or Zilver PTX. Endpoints included event-free survival (EFS), stent integrity by radiographic core laboratory analysis and primary patency by Duplex ultrasound core laboratory analysis (peak systolic velocity ratio 55 institutions in the United States, Japan and Germany, with 241 patients randomized to the Zilver PTX group and 238 to the balloon angioplasty group. Demographics and lesion characteristics were similar for both groups. Approximately half the balloon angioplasty group experienced acute failure and underwent secondary randomization, assigning 59 and 61 patients to provisional stenting with Zilver BMS and Zilver PTX, respectively.
The study met its 12-month primary endpoint by showing non-inferior EFS and superior patency for the Zilver PTX compared to balloon angioplasty. There was also significant clinical improvement in the group receiving Zilver PTX. Angiotech believes the results of this randomized, multicenter study support the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent.
"These results establish paclitaxel as the only anti-restenosis drug to ever demonstrate efficacy in the treatment of PAD in a large, randomized, clinical trial," said Dr. William Hunter, President and CEO of Angiotech. "We are optimistic that this study will support Cook's application with the FDA to become the first drug eluting peripheral stent available for the management of patients suffering from PAD in the United States."
About Zilver PTX
The Zilver PTX stent was CE Marked in August 2009 and has been made available in Europe since September of 2009. It is the first drug-eluting stent indicated for treating PAD in the SFA, an often difficult-to-treat blood vessel in the leg. Upon deployment, the Zilver PTX stent expands and holds open the artery to restore blood flow. It then delivers the drug paclitaxel to the cells in the vessel wall to reduce the risk of new blockages forming. Cook licenses the rights to use paclitaxel on peripheral stents and other non-coronary medical devices from Angiotech. In the United States, the Zilver PTX Drug-Eluting Stent is an investigational device not available for sale at this time.
PAD is caused by atherosclerosis - the build-up of fatty deposits (atheroma) within the lining of the arteries. The most common symptom of PAD is leg pain during exercise. Over time the arteries may narrow due to atherosclerosis, resulting in a reduction in blood flow. Severely reduced blood flow in the limbs is also known as critical limb ischemia (CLI). It is characterized by leg pain at rest, non-healing wounds, and gangrene, and may lead to amputation of the limb.
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, as amended, and our quarterly report for the 2nd quarter of 2010 filed with the SEC on Form 10-Q.
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.
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<http://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<http://www.cookmedical.com>.
Zilver PTX is a trademark of William Cook Europe A/S.
For further information: Rick Smith, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (604) 221-6933, firstname.lastname@example.org
Posted: September 2010