Angiotech Pharmaceuticals, Inc. - New study shows that Zilver PTX effectively treats blockages in critical thigh artery

VANCOUVER, April 14 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced its corporate partner, Cook Medical, reported data on two-year follow up that showed that 82 percent of patients who were treated with Cook Medical's Zilver(R) PTX(TM) drug-eluting peripheral stent (DES) were free from reintervention at two-year follow up. The Zilver PTX Registry study, involving 792 patients from across the world, is assessing the safety and efficacy of the Zilver PTX in treating PAD. The most recent results were reported at the 31st International Symposium: Charing Cross Controversies Challenges Consensus.

"These results are extremely encouraging as it's the first time paclitaxel-coated stents have been used in the treatment of blockages in arteries outside the heart," said Zilver PTX global principal investigator, Dr. Michael Dake, Professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and Medical Director of the Cath/Angio Laboratories at Stanford University Medical Center. "Patients treated with the Zilver PTX had a very low complication rate and required fewer reinterventions."

Data was compiled at 12 and 24 months for 593 patients and 177 patients respectively from the registry study, which enrolled a broad spectrum of patients, including those with complex lesions (e.g., long lesions, total occlusions, in-stent restenosis). The corresponding event-free survival (EFS) rates were 87 percent and 78 percent, and freedom from TLR (target lesion revascularization) was 89 percent and 82 percent. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six and 12 months and were maintained through 24 months.

Detailed evaluation of stent x-rays demonstrated excellent stent integrity through 12 months, confirming previously published results showing 99 percent completely intact stents with a mean follow up of 2.4 years in the challenging superior femoral artery and popliteal arteries, including behind the knee locations.

One in five in the 65- to 75-year-old age group in the UK* has peripheral arterial disease (PAD). Yet only a quarter of these people have any symptoms at all. The 'silent' nature of this condition can result in a number of patients being diagnosed only when their condition has progressed to the severe stage. In patients with severe PAD whose condition is not improving with risk-factor modification, exercise programs and pharmacological therapy, invasive procedures may need to be carried out. These procedures include angioplasty, stenting or surgery.

"We are impressed with both the efficacy and durability demonstrated by the Zilver PTX in the registry study and believe we will see similar results in the US randomized trial which is currently ongoing," said Dr. Bill Hunter, President and CEO of Angiotech. "Our partner, Cook Medical, has been committed to continually improving the efficacy and safety of peripheral DES and early results suggest that the self-expanding, Zilver PTX stent will be an important treatment option for patients with PAD."

In addition to the registry arm of the study, the 480 patient randomized component is designed to evaluate the Zilver PTX across 45 trial sites in the United States, Japan and Europe. Of the 480 patients enrolled in the randomized study, 240 received the Zilver PTX DES. Enrollment in the randomized study was completed in 2008. For more information, please visit www.zilverptxtrial.com

 

* Fowkes FGR, Housley E, Cawood EHH, MacIntyre CAA, Ruckley CV,

Prescott RJ. Edinburgh artery study: prevalence of asymptomatic and

symptomatic peripheral arterial disease in the general population. Int J

Epidemiol 1991;20:384-91.

 

Cook licenses the rights to use paclitaxel with peripheral stents and other non-coronary medical devices from Angiotech. Under the terms of its 1997 license agreement with Cook, Angiotech is entitled to ereceive royalty payments upon the commercial sale of paclitaxel-eluting peripheral vascular products, including the Zilver PTX. 

 

Forward Looking Statements

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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 U.S. Private Securities Litigation Reform Act of 1995 and "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 2009 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research, development, 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 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 and to expand manufacturing and commercialization activities or consummate acquisitions; 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 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 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 continued availability of capital to finance our activities; and any other factors referenced in our other filings with the Securities and Exchange Commission ("SEC") and applicable Canadian regulatory authorities. 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, 2008 filed with the SEC on Form 10-K. 

Given these uncertainties, assumptions and risk factors, readers 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)2009 Angiotech Pharmaceuticals, Inc. All Rights Reserved. 

About Angiotech Pharmaceuticals 

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.       -30-  /For further information: DeDe Sheel, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412, dede.sheel@fdashtonpartners.com/
 

Posted: April 2009

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