Angiotech Initiates Pivotal U.S. Study of Anti-Infective CVCs

VANCOUVER -- Angiotech Pharmaceuticals, Inc. today announced the initiation of its United States pivotal study examining an antimicrobial central venous catheter (CVC). This U.S. multi-center study is designed to evaluate the efficacy of a CVC coated with the drug 5-Flourouracil (5-FU), a non-traditional anti-infective agent. The study enrolled its first patient last week in Rapid City, S.D. and will involve approximately 600 patients at 20 centers in the United States.

Central venous catheters are usually inserted into critically ill patients for extended periods of time to administer fluids, drugs, and nutrition, as well as facilitate frequent blood draws. One of the complications associated with CVC implantation is infection, which can occur when bacteria contaminate the catheter. CVC infections that progress to bloodstream infections, or septicemia, can become life threatening. Approximately 3.5 million CVC catheters are used in the U.S. annually, leading to approximately 250,000 CVC-related infections and an estimated 40,000 deaths. The cost of caring for these patients is estimated to be as high as $56,000 per infection.

Angiotech is developing its infection prevention platform using the drug 5-FU as a non-traditional anti-infective in order to address concerns voiced by the Centers for Disease Control and Prevention (CDC) regarding overuse of traditional antibiotics, which can contribute to an increase in the antibiotic resistance of bacteria. Traditional anti-infective coatings are being used more frequently each year, and are currently used on approximately 20 percent of CVC products implanted.

"We are excited to be participating in a study addressing such a pervasive and critical issue," said Jorge Reyno, MD, an infectious disease specialist at Rapid CityRegionalHospital in South Dakota where the first patient was recently enrolled. "Hospital-based infections, which include CVC infections, are a vexing and potentially lethal problem that demands a better solution."

"The use of 5-FU as an anti-infective coating to prevent catheter-related bloodstream infections is innovative and unique," said Stephen Heard, MD, chair of the Department of Anesthesiology at University of Massachusetts Memorial Medical Center and the University of Massachusetts Medical School, and principal investigator. "(In vitro) data demonstrate that 5-FU has antibacterial activity similar to current anti-infective catheter surfaces. We are eager to see if these effects impact catheter colonization and bloodstream infection in patients."

"Two million patients contract hospital-based infections in the U.S. each year," said Betsy McCaughey, Ph.D, chairman of the Committee to Reduce Infection Deaths (RID). "RID applauds the efforts of innovative pharmaceutical companies to reduce catheter-based infections."

Source: Angiotech Pharmaceuticals