Angiotech Pharmaceuticals, a Vancouver, BC company, has announced suspension of enrollment in its U.S. and EU human clinical trials for the company’s Vascular Wrap product candidate “in patients undergoing surgery for hemodialysis access, pending a safety review to evaluate an imbalance of infections that have been observed between the two study groups.” Vascular Wrap is a paclitaxel-eluting surgical mesh that was designed to inhibit the growth of scar tissue (neointimal hyperplasia) inside a synthetic vascular graft, thought to decrease failure rates of dialysis access catheters. The product, that has shown promise in an animal model, has now hit a snag.
The company explains:
The U.S. and EU trials each consist of two study groups; (1) patients who received the graft / Vascular Wrap ombination; and, (2) patients who received the graft alone.
At the onset of this study Angiotech established an independent Data Safety Monitoring Board (DSMB) in the U.S. to monitor any unexpected risks or safety issues. Angiotech recently submitted a safety summary of adverse events from the U.S. clinical trial to the DSMB, based upon having reached the 25% enrolment threshold in the U.S. clinical trial. Subsequent to that submission, Angiotech received a communication from the DSMB that one of the study groups had a greater incidence of implant site infection in comparison with the other study group.
Angiotech is blinded to the groups and not currently aware of whether the increased rate of infection is in the patient group that received the graft / Vascular Wrap combination or in the patient group that received the graft alone. As a result of these observations, Angiotech has elected to notify physicians to suspend further enrolment in the trials, pending a full review of the potential cause of the implant site infections.
“We regard patient safety as the paramount obligation of any company in our industry, and upon further adjudication of the clinical data, we hope to identify the underlying cause of these observed events, and to make a prudent and sensible decision regarding the future of this clinical development program,” said Dr. Jeff Walker, Chief Scientific Officer of Angiotech.