>>SOUTH SAN FRANCISCO, Calif., June 24 /PRNewswire-FirstCall/ -- Corgentech Inc. (Nasdaq: CGTK - News) today announced that the Steering Committee responsible for the oversight of its Phase III trial evaluating edifoligide (E2F Decoy) for the prevention of coronary artery bypass graft (CABG) failure advised that the trial could continue as planned with no recommended changes.
The Steering Committee made this recommendation after reviewing the current status of the trial and the most recent report from the trial's independent Data Safety Monitoring Board (DSMB). In its final scheduled review, the DSMB advised the Steering Committee that no additional patients needed to be added to the 2,400 fully enrolled and planned in the cohort for angiographic follow-up currently underway. The DSMB reached this conclusion after examining the results of angiographic follow-up data from approximately one-third of the untreated patients, or placebo arm, enrolled in the PREVENT IV CABG trial. The trial remains blinded and no relevant data on treatment effect was reviewed. In addition, there were no safety issues identified.
"We appreciate the efforts of the Steering Committee and DSMB and look forward to reporting the results of this trial early next year as planned," stated John McLaughlin, Corgentech's president and chief executive officer.
The Steering Committee and Data Safety Monitoring Board meet periodically to assess trial progress and monitor any safety issues that may arise. Both committees consist of physicians with expertise in cardiovascular disease and who have extensive experience conducting and evaluating clinical trial design, safety and data analysis.
Edifoligide (E2F Decoy) currently is in follow-up stages of two Phase III clinical trials for prevention of bypass graft failure following CABG surgery (PREVENT IV trial) and peripheral bypass graft surgery in the leg (known as PREVENT III and not the subject of this review). The PREVENT IV CABG trial requires that the 2,400 enrolled patients have an angiogram at 12 months post-surgery. Edifoligide (E2F Decoy) has received FDA Fast Track designation for the prevention of vein graft failure. Corgentech and Bristol-Myers Squibb Company have an agreement to jointly develop and commercialize edifoligide (E2F Decoy), as well as co-promote the product in the U.S.
About Graft Failure
Approximately 370,000 CABG surgeries were performed in the U.S. in 2001; however, approximately 19 percent of these vein grafts fail within one year of surgery, with the failure rate climbing to about 50 percent between years 10 and 15. The ramifications of failure for CABG patients include heart attack, chest pain, congestive heart failure, irregular heartbeat and death.<<
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Cheers, Tuck |
