Corgentech and Bristol-Myers Squibb Announce Results From Edifoligide (E2F Decoy) Phase 3 Trial for Peripheral Bypass Graft
Monday December 6, 7:01 am ET
Corgentech to Host Webcast Conference Call Scheduled for 8:30 a.m. EST
SOUTH SAN FRANCISCO, Calif., and PRINCETON, N.J., Dec. 6
/PRNewswire-FirstCall/ -- Corgentech Inc. (Nasdaq: CGTK - News), and Bristol-Myers
Squibb Company (NYSE: BMY - News) today announced top-line results from the first of
two Phase 3 clinical trials for edifoligide (E2F Decoy) an investigational
product to treat vein graft failure of the heart and leg. Edifoligide (E2F
Decoy) was generally well tolerated during the 30-day observation period in
the PREVENT III trial-an approximately 1,400-patient, Phase 3 trial of
edifoligide (E2F Decoy) in peripheral artery (i.e. leg) bypass graft (PBG)
failure. The primary and secondary endpoints failed to show a benefit in the
edifoligide-treated group compared to the placebo group as defined as the rate
of vein graft failure over the 12 months following surgery. The complete data
from the PREVENT III trial will be presented in future scientific publications
and presentations by the study's clinical investigators. Corgentech and
Bristol-Myers Squibb have an agreement to jointly develop and commercialize
Corgentech's edifoligide (E2F Decoy). Corgentech will host a webcast
conference call at 8:30 a.m. EST to review the clinical data announced today.
"Edifoligide (E2F Decoy) is also being evaluated in a separate Phase 3 study (PREVENT IV) in coronary artery bypass grafts (CABG), and we anticipate the results from this trial by the end of the first quarter of 2005. Following the availability of these results, we will be working with our partner Bristol-Myers Squibb and the FDA on what could be an appropriate development strategy for edifoligide," stated John McLaughlin, president and chief executive officer of Corgentech.
The FDA had previously granted Fast Track status for the use of edifoligide (E2F Decoy) to prevent the failure of bypass grafts.
PREVENT III Trial Design
The Phase 3 clinical trial was a randomized, double blind, placebo- controlled trial involving 1,400 patients undergoing PBG surgery in the leg at approximately 80 centers. Patients were randomized to undergo a one-time treatment with edifoligide (E2F Decoy) or placebo. The trial's primary endpoint compared differences between the treatment and placebo groups in time from the peripheral bypass graft surgery to the first procedure needed to repair a failed/failing vein graft or limb amputation within the 12 months following surgery. Patients were assessed by ultrasound examination at one, three, six and 12 months after bypass surgery to determine if and when a vein graft failed.
PREVENT IV Trial Design
A separate Phase 3 trial, called PREVENT IV, involved 2,400 patients undergoing CABG at over 100 centers and its primary endpoint is the percent reduction in the incidence of critical graft stenosis between the edifoligide (E2F Decoy) treated and placebo groups. Critical graft stenosis is defined in the trial as blockage of the graft of 75 percent or greater as measured by
quantitative coronary angiography at 12 months. Today's PREVENT III data are
not necessarily predictive of the data to be revealed from PREVENT IV.
Edifoligide (E2F Decoy) Administration
Edifoligide therapy is a treatment applied to the vein by the surgeon in the operating room, just prior to implanting the vein as a bypass. The vein is treated outside of the body by bathing it in the drug in a procedure that is easily incorporated to the standard surgical bypass operation... |
