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Patient Enrollment Completed for Phase III Trial of E2F Decoy, Novel Vascular Therapy
"While peripheral bypass procedures can effectively restore blood flow to the leg, 30 to 50 percent of vein grafts eventually become blocked and fail," said Lynn Seely, M.D., vice president of clinical research for Corgentech. "There currently is no approved treatment to prevent vein graft failure and too many of these patients must undergo a second bypass surgery or amputation."
"E2F Decoy is a novel treatment with the potential to improve outcomes for patients undergoing bypass surgery by extending the life of vein grafts used to bypass blockages in the arteries," said Michael S. Conte, M.D., associate professor of surgery at the Brigham and Women's Hospital in Boston and chair of the PREVENT III steering committee. "This is a landmark study for the vascular surgery community and we are pleased to have reached this important milestone."
The peripheral bypass graft trial, known as PREVENT III, was initiated in November 2001 and includes 1,400 patients at more than 80 leading medical centers in the United States and Canada. Approximately 150,000 peripheral bypass procedures are performed in the United States each year to correct reduced blood flow to the leg, a condition that can cause pain, open sores or ulcers that won't heal, infections like gangrene, and can result in amputation of the toes, foot or leg.
"We are pleased that enrollment of patients for both this and the coronary trial have progressed right on schedule, marking a major corporate milestone for Corgentech," said John McLaughlin, Corgentech's president and CEO. "We look forward to working closely with the FDA as we move through these late- stage trials and toward registration."
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.
About the CGT003 Trial
In this multi-center, placebo-controlled, double-blind, randomized Phase 3 study, patients undergoing peripheral bypass graft surgery have been randomized to undergo treatment with CGT003 or a placebo (i.e. saline) solution. The primary efficacy endpoint will compare between E2F Decoy and placebo the occurrence of blockage requiring reintervention or revision of the graft or amputation of the leg.
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 one time ex vivo (outside the body) with CGT003 in a pressure device during the 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.
Source: Corgentech Inc.