Media
Corgentech Completes Enrollment of Pivotal Phase 3 Trial Studying E2F Decoy in Coronary Artery Bypass Graft Failure
SOUTH SAN FRANCISCO, Calif., Sept. 18, 2003 -- Corgentech Inc., a privately held biotechnology company, announced today that the company has completed patient enrollment in a pivotal Phase 3 clinical trial to evaluate its lead product, CGT003, a first-of-its-kind E2F Decoy therapy for the prevention of graft failure following coronary artery bypass graft (CABG) surgery. The trial, known as PREVENT 4, was initiated in August 2002 and is taking place in more than 100 leading medical centers in the United States. Approximately 500,000 heart bypass procedures are performed for life-threatening cardiovascular disease in the United States each year.
"With 30 to 50 percent of coronary artery bypasses eventually failing, vein graft blockage is a long-standing and serious problem for which there is no approved treatment," said Todd Lorenz, M.D., Corgentech's chief medical officer. "Enrollment in this trial has been rapid, with 2,400 patients enrolled in just over 12 months. We are pleased to achieve this major clinical milestone in the development of CGT003 and are hopeful it will improve outcomes for CABG failure patients whose only current option is additional bypass surgery with higher operative mortality rates."
CGT003 is E2F Decoy, an oligonucleotide that binds to and inactivates the pivotal cell-cycle transcription factor E2F, administered in Corgentech's proprietary drug-delivery device. E2F is responsible for activating a dozen or more genes that must be turned on during vascular cell growth and multiplication. Its blockade prevents the proliferation of these abnormal cells that eventually result in atherosclerosis and blockage of the graft.
"The E2F Decoy treatment may allow us, for the first time, to extend the life of vein grafts used in coronary bypass operations. Results from the Phase 2b trial indicate this new treatment may help decrease blockages that lead to graft failure," said Randall Wolf, M.D., Professor of Surgery and Director of the Center for Surgical Innovation at the University of Cincinnati College of Medicine, and a member of the PREVENT 4 Steering Committee.
CGT003 is also being evaluated in a Phase 3 clinical trial for the prevention of peripheral (i.e. leg) arterial bypass graft failure. The U.S. Food and Drug Administration (FDA) will require both the coronary and peripheral Phase 3 trials for approval. The FDA has granted CGT003 Fast Track status for these indications due to the important unmet medical needs it addresses.
About the CGT003 Trial
This multi-center, placebo-controlled, double-blind, randomized Phase 3 study is co-sponsored by The Society for Thoracic Surgeons, with the Duke Clinical Research Institute as the CRO. Patients undergoing coronary artery bypass grafting have been randomized to undergo treatment with CGT003 or a placebo (i.e. saline) solution. The primary efficacy endpoint is a comparison between the treatment and placebo groups of the occurrence of critical graft stenosis (i.e., blockage), which is defined as 75 percent or greater blockage. Patients will be monitored following surgery and graft stenosis will be measured by angiography at a minimum of 12 months post surgery. In addition to the 2,400 patients in the pivotal trial, 600 more patients will be enrolled in the coming months as part of a five-year post-approval follow-up study.
More About CGT003
In addition to blocking expression of the gene that contributes to atherosclerosis, this treatment also allows grafts to undergo adaptive wall thickening by hypertrophy, expansion and strengthening, of the graft's normal muscular layer over time, making the vein act more like an artery, which can better maintain healthy blood flow. Vein grafts are treated ex vivo (outside the body) with CGT003 in a pressure device during CABG surgery. Because treatment of the graft occurs while outside the body, there is minimal, if any, systemic exposure. This is expected to result in an excellent safety profile. This treatment is easily incorporated into the surgical procedure and does not impact the surgeon's technique.
About Corgentech Inc.
Corgentech Inc. is a privately held biotechnology company that is the leader in the discovery, development and commercialization of an exciting and powerful new class of therapeutics called transcription factor decoys or TF Decoys. The company's proprietary technology platform is capable of delivering multiple new product candidates to treat diseases that affect large patient populations in a relatively short period of time. Currently, the company is focused in three therapeutic areas: cardiovascular disease, inflammatory disease and cancer. Corgentech is based in South San Francisco, Calif. For more information on the company and its technology, visit www.corgentech.com.
| Contacts: | |
| Richard Powers Corgentech |
Kristin Nash WeissCom Partners |
| 650-624-9600 [email protected] |
415-302-7951 [email protected] |
