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
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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, email@example.com
Posted: September 2010