Clinical Trials
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Our discovery approach has yielded a number of product candidates that are in various stages of research and clinical development. Selected product candidates currently undergoing human clinical trials include:
- Vascular Wrap™ paclitaxel-eluting mesh surgical implant (“Vascular Wrap”)
- 5-fluorouracil-eluting anti-infective central venous catheter (“CVC”)
- Bio-Seal™ biopsy track plug
- Non drug-loaded sprayable biomaterial adhesion barrier (Adhibit™)
- Paclitaxel-eluting peripheral vascular stent
Vascular Wrap™ paclitaxel-eluting mesh surgical implant (“Vascular Wrap”)
The Vascular Wrap™ surgical mesh is intended to treat complications associated with vascular graft implants in peripheral vascular disease and hemodialysis patients.
The Vascular Wrap surgical mesh is currently undergoing human clinical trials in the EU, where 109 patients have been enrolled in a study examining the safety of the Vascular Wrap surgical mesh in patients with peripheral vascular disease. We are currently evaluating the data from this study in order to prepare for a possible CE Mark filing. Should we file for a CE Mark, and subsequently receive CE Mark approval from the EU regulatory authorities, we would, together with our partner Edwards Lifesciences, be able to market and sell the Vascular Wrap surgical mesh in the EU. During the quarter we announced positive results from a preclinical study to evaluate the efficacy of the Vascular Wrap surgical mesh on inhibiting the growth of scar tissue (neointimal hyperplasia) inside a synthetic vascular graft in an animal model of dialysis access failure. In this study, neointimal hyperplasia was reduced by a minimum of 87.6% in animals who received a Vascular Wrap surgical mesh compared with animals who received no Vascular Wrap surgical mesh.
Based upon this preclinical data, we will soon begin to enroll a clinical trial in the United Kingdom to assess the effectiveness and safety of the Vascular Wrap surgical mesh in patients receiving a Lifespan® synthetic vascular graft for the purposes of providing hemodialysis access. Specifically, the trial seeks to determine that hemodialysis patients who receive the Vascular Wrap surgical mesh / Lifespan graft combination experience fewer graft failures than those patients that receive the Lifespan graft alone. We also intend to conduct a similar trial in the U.S. Both trials are expected to be about 24 months in duration, with enrollment taking approximately one year. The goal of the studies is to provide Angiotech with sufficient data to submit to regulatory authorities for approval to market the Vascular Wrap surgical mesh for use in hemodialysis patients in the United States and the EU.
5-fluorouracil-eluting anti-infective central venous catheter (“CVC”)
In October 2007, Angiotech announced that it intends to file Premarket Notification 510(k) documents with the U.S. Food and Drug Administration for its innovative, anti-infective 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC).
In July 2007, Angiotech completed enrolment of 960 patients in the clinical trial of its 5-FU CVC, which was one of the largest CVC studies ever conducted. Designed as a randomized, single-blind, active-controlled, two-arm, multi-center clinical study, the primary objective is to compare the Angiotech 5-FU CVC to a leading anti-infective catheter with regards to preventing bacterial colonization.
Angiotech plans to present the 5-FU CVC pivotal study results at the "37th Critical Care Congress" hosted by the Society of Critical Care Medicine, which will be held on February 2-6, 2008 at the Hawaii Convention Center.
About the 5-FU CVC
Angiotech believes that 5-FU, a well-known and approved compound, has the potential to be used as a coating to prevent catheter-related infections as effectively as traditional antiseptics and antibiotics. In addition, since 5-FU has no clinical application as either a systemic antibiotic or a hospital antiseptic, there is little risk to the hospital or the community at-large of creating a "super-bug" that is resistant to a useful class of antibiotic and can make infection control more complex.
The principle behind using 5-FU on a CVC is that the drug appears to effectively interrupt the colonization of an implanted medical device by those micro-organisms that typically gain entrance to the bloodstream via the local skin penetration of implanted catheters. This reduction in colonization by bacteria may have a net effect of reducing biofilm burden on the implanted catheters, making them less likely to serve as reservoirs for additional infection.
Bio-Seal™ biopsy track plug
Our proprietary Bio-Seal™ biopsy track plug is under evaluation in a pivotal human clinical trial. Bio-Seal™ is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydrogel plug. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture. The seal is airtight and the plug is absorbed into the body after healing of the puncture site has occurred.
Bio-Seal™ is currently undergoing a human clinical trial in the U.S. designed to assess the safety and efficacy of the Bio-Seal™, with the primary endpoint being reduction in rates of pneumothorax in patients undergoing lung biopsy procedures. The clinical trial, which is expected to enroll a total of 300 patients in the U.S., is a prospective randomized multi-centered safety and efficacy evaluation. The trial enrolled its first patient in October 2005, and there were 229 patients enrolled in the study as of September 30, 2007. The study is designed to provide a basis for U.S. approval for the commercialization of Bio-Seal™. The product has already received CE Mark approval.
Non drug-loaded sprayable biomaterial adhesion barrier (Adhibit™)
Angiotech's non drug-loaded Adhibit sprayable barrier product is designed to provide for the reduction of surgery-induced adhesions that can occur after a procedure to remove fibroids from the uterus (myomectomy surgery). In April 2006, we announced data from our 71 patient human clinical study conducted in the EU, designed to assess the safety and efficacy of Adhibit sprayable barrier in preventing adhesions in patients undergoing the myomectomy procedure. The data indicated that the use of Adhibit sprayable barrier reduced post-operative adhesion formation as measured by the modified American Fertility Society ("mAFS") score, a scoring system that factors in both the extent and tenacity of adhesions. Patients in the group that were treated with Adhibit sprayable barrier experienced a statistically significant reduction in their mAFS score when compared with those in the control group. We are currently evaluating, together with our partner Baxter Healthcare Corporation, the timing and form of any regulatory submission for approval of this indication in the EU. We granted Baxter Healthcare Corporation exclusive worldwide (excluding the U.S.) marketing and distribution rights to our non-drug loaded Adhibit sprayable barrier product, with an option to obtain marketing and distribution rights in the U.S.
Paclitaxel-eluting peripheral vascular stent
The peripheral vascular stent, developed by our partner the multinational medical device manufacturer Cook Group, Inc. (“Cook”), is designed for placement in diseased arteries in the limbs to restore blood flow and improve a patient's ability to walk. The Zilver paclitaxel-eluting peripheral stent, designed to reduce restenosis following placement of a stent in peripheral artery disease patients, is currently undergoing human clinical trials in the United States and the EU to assess product safety and efficacy. These studies are being conducted by our partner Cook, which is a co-exclusive licensee, together with BSC, of our proprietary paclitaxel technology to reduce restenosis following stent placement in peripheral artery disease.