Corgentech, and Bristol-Myers Squibb Company announced top-line results from PREVENT IV, a Phase 3 clinical trial evaluating the use of edifoligide (E2F Decoy).
E2F Decoy is an investigational product, to prevent vein graft failure following coronary artery bypass graft (CABG) surgery. Treatment with E2F Decoy failed to meet the trial’s primary and secondary endpoints. E2F Decoy was generally well tolerated in the 3,014-patient trial.
The complete data from the PREVENT IV 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 E2F Decoy. Bristol-Myers Squibb has advised Corgentech that it will be terminating the collaboration consistent with the agreement.
“We will conclude our Phase 1 trial in AV grafts and do not plan to develop E2F Decoy further. We are grateful to BMS for the support that they have provided to Corgentech and to this program and have enjoyed working closely with them on this collaboration,” said John McLaughlin, president and chief executive officer of Corgentech. “We are fortunate to have a deep pipeline of products to choose from and have the ability to generate new product candidates very rapidly. Corgentech’s NF-kappaB (NFkB) Decoy, which was generated in just five months, will enter the clinic shortly for eczema, and we plan to select our next clinical candidate in the second half of this year.”
This multi-center, placebo-controlled, double-blind, randomized Phase 3 study was conducted in collaboration with The Society of Thoracic Surgeons and the Duke Clinical Research Institute, an academic research organization. The Phase 3 clinical trial involved 3,014 patients undergoing CABG surgery at over 100 centers, and its primary endpoint was the percent reduction in the incidence of graft failure between the E2F Decoy treated and placebo groups. Graft failure was defined in the trial as blockage of the graft of 75 percent or greater as measured by quantitative coronary angiography at 12 months. Safety was assessed by monitoring adverse events, post-operative complications and laboratory abnormalities.
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