Positive Preclinical Data on Vascular Wrap(TM) Presented at Vascular Conference
17 September 2006 - 9:00PM
PR Newswire (US)
New Technology Has Potential to Improve Quality of Life for
Hemodialysis Patients VANCOUVER, Sept. 17 /PRNewswire-FirstCall/ --
Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP),
a global specialty pharmaceutical and medical device company, today
announced positive preclinical data related to its Vascular
Wrap(TM) paclitaxel-eluting mesh and Lifespan(R) graft technology
platform at The Western Vascular Society 2006 Annual Meeting in La
Jolla, California. "We are excited by the potential of the Vascular
Wrap paclitaxel-eluting mesh product in a variety of indications,
including AV access for hemodialysis patients," said Dr. William
Hunter, President and CEO of Angiotech Pharmaceuticals. Although
synthetic grafts are currently used in approximately 40 percent of
hemodialysis patients who require a permanent vascular access,
primary patency rates remain poor. Most graft failures are caused
by growth of scar tissue inside the graft (neointimal hyperplasia)
at the location where the graft is connected to the vein (the
graft-vein anastomosis), and there are no proven treatments that
effectively prevent it. The purpose of this preclinical study was
to evaluate the effect of the Vascular Wrap(TM) bioabsorbable mesh
containing paclitaxel on inhibiting neointimal hyperplasia 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 paclitaxel-eluting mesh compared with animals who
received no mesh. "We are encouraged by the results of our
preclinical data, and believe that we may be able to offer a better
treatment option for hemodialysis patients," said Dr. Rui Avelar,
Chief Medical Officer of Angiotech Pharmaceuticals. "These results,
complemented by the extensive experience with paclitaxel in
cardiovascular applications, have given us further confidence as we
look to start our clinical studies in hemodialysis access." Earlier
in August, Angiotech announced the intent to launch a clinical
trial in the United Kingdom to determine if hemodialysis patients
who receive the Vascular Wrap paclitaxel-eluting mesh/Lifespan
graft combination product experience fewer graft failures than
those patients that receive the graft alone. Angiotech expects to
enrol the first patient in the UK-based clinical trial this fall.
The company also intends to conduct a similar trial in the U.S.
Both trials are expected to be about 24 months in duration, with
enrolment taking approximately one year. The goal of the studies is
to provide Angiotech with sufficient data to submit to regulatory
authorities for the approval to market the products in the United
States and Europe. About the Study and Presentation Dr. Ted Kohler,
MD, MSc, of the Veteran Affairs Puget Sound Health Care System, is
the principal investigator of this study, and presented the results
today at the Western Vascular Society 2006 Annual Meeting held at
the Hilton La Jolla Torrey Pines Hotel in La Jolla, California.
Commercially available grafts were surgically placed between the
left common carotid artery and right external jugular vein in 40
animals, which were randomized to receive either no mesh or a 3 cm
by 6 cm mesh placed around the graft-vein anastomosis containing
one of four doses of paclitaxel (0.0, 0.3, 0.7 or 1.2
(micro)g/mm2). Animals in both control groups developed significant
neointimal hyperplasia at the cross-section taken perpendicular to
the graft at its most distal end: 10.5 +/- 6.8 mm2 and 6.4 +/- 3.2
mm2 in the no mesh and zero-dose mesh groups, respectively (P =
.28). Compared with the zero-dose mesh group, neointimal area was
significantly reduced in all paclitaxel mesh groups: 0.9 +/- 1.4
mm2, 1.3 +/- 1.5 mm2 and 1.2 +/- 1.4 mm2 in the three dose groups,
respectively (P