Clinical Trials
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We currently have multiple product candidates that are in various stages of research and clinical development. The following discussion outlines our most advanced product candidates and their stage of development, and summarizes our clinical development programs.
- Bio-Seal™ Lung Biopsy Tract Plug System
- Option™ Vena Cava Filter
- Anti-Infective HemoStream™ Dialysis Catheter
- MultiStem® Stem Cell Therapy
Bio-Seal™ Lung Biopsy Tract Plug System
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 has undergone a human clinical trial in the United States which was designed to assess the safety and efficacy of Bio-Seal, with the primary endpoint being reduction in rates of pneumothorax in patients undergoing lung biopsy procedures. The clinical trial was a prospective randomized multi-centered safety and efficacy evaluation. The trial enrolled its first patient in October 2005 and completed enrolment in June 2008. The study was designed to provide a basis for U.S. clearance for the commercialization of Bio-Seal. Data from this clinical trial study has been submitted to the FDA. The FDA has responded to our submission with additional questions about the study. We have responded to the FDA, and upon further review by the FDA we may either receive 510(k) clearance to market Bio-Seal in the United States or be required to respond to additional questions or conduct additional clinical studies for this product candidate. Upon receiving such further information from the FDA, we will determine the timing of product launch or any further development work necessary to achieve approval should we choose to continue the development of this product candidate.
The complete data for the Bio-Seal study was presented at the 2009 Society of Interventional Radiology in San Diego, CA on March 9, 2009. The trial hit its primary end point with clinical success in 85% of the treatment patients compared to 69% for the control patients (p=0.002). The product has already received CE Mark approval.
Option™ Vena Cava Filter
The Option Vena Cava Filter, which we licensed in March 2008 from our partner Rex Medical L.P., is under evaluation in a pivotal human clinical trial. We believe this vena cava filter may have a number of potential benefits, which include unique filter apex and retention anchors, insertion through either the femoral or jugular route, and non-thrombogenic material. The purpose of the United States multi-center prospective clinical trial is to evaluate the device's safety and efficacy in preventing pulmonary emboli, and to assess the ability to retrieve the device from the body up to 175 days following implantation.
Interim results of the pivotal trial were presented at the AIM/Veith Meeting in New York in November 2008. The complete results, representing a total of 100 patients, were presented at the 2009 Society of Interventional Radiology Meeting in San Diego, CA. The clinical data from this trial was submitted to the FDA and on June 8, 2009, Angiotech announced that the FDA granted 510(k) clearance for the Option (IVC) Filter in the United States, for use in both permanent and retrievable indications. Please see our press release for more information.
Anti-Infective HemoStream™ Dialysis Catheter
We have an FDA-approved dialysis catheter, HemoStream, that we sell through our direct sales force. A dialysis catheter is used for exchanging blood between a hemodialysis machine and a patient. Some common malfunctions of dialysis catheters include clotting, infection, and kinking. Through our proprietary drug identification strategy, we have identified 5-Fluorouracil (“5-FU”), a drug previously approved by the FDA for treatment of various types of cancer, as a compound that may help to prevent certain types of infection in patients receiving selected types of implantable devices, including certain dialysis catheters. We are currently developing this 5-FU anti-infective technology for our HemoStream dialysis catheter line, and we currently anticipate filing in 2009 for a 510(k) clearance to market this product candidate in the U.S.
MultiStem® Stem Cell Therapy
The MultiStem stem cell therapy is under evaluation in clinical trials being conducted together with our partner Athersys, Inc. (“Athersys”) for the treatment of acute myocardial infarction. MultiStem stem cells are proprietary adult stem cells derived from bone marrow, which have demonstrated the ability in laboratory experiments to form a wide range of cell types. MultiStem may work through several mechanisms, but a primary mechanism appears to be the production of multiple therapeutic molecules produced in response to inflammation and tissue damage. We and Athersys believe that MultiStem may represent a unique “off the shelf” stem cell product candidate, based on its potential ability to be used without tissue matching or immunosupression, and its potential capacity for large scale production. We entered an agreement with Athersys in May 2006 to co-develop and commercialize MultiStem for use in the indications of acute myocardial infarction and peripheral vascular disease. On December 20, 2007, we and Athersys announced we had received authorization from the FDA to commence a phase I human clinical trial to evaluate the safety of MultiStem in the treatment of acute myocardial infarction. Upon completion of a phase I human clinical trial currently being conducted by Athersys, we may assume lead responsibility for further clinical development. We currently own marketing and commercialization rights with respect to this product candidate.
On September 22, 2008, as part of certain cost reduction initiatives, we announced a potential amendment of, and reduction in, cash outlays related to our collaboration with Athersys. The final terms of such amendment to our collaboration with Athersys may have an impact on our expected future expenditures for research and development of MultiStem, and the extent of our future financial and commercial commitments and rights relating to this product candidate.