VASOGEN STOPS CELACADE TRIAL EARLIER THAN PLANNED
Canadian drug developer Vasogen has halted a late-stage clinical trial of its lead product Celacade earlier than planned, after the drug wasn't shown to be very effective.
The Phase III trial, known as "Simpadico," enrolled approximately 553 patients with peripheral artery disease, gave them either Celacade or placebo, and followed their progress for up to a year. The primary endpoint of the trial was an improvement in maximum walking distance.
A steering committee for the trial recommended cutting the study short based on the absence of a sufficiently strong efficacy signal and their observation of a modest imbalance in the distribution of a small number of malignancy cases.
Vasogen said a review concluded that safety concerns did not exist. The company plans to release data from the trial after it has been analyzed.