ViRexx Medical has reported that enrollment has been completed for the first of two identical Phase III trials for OvaRex MAb, IMPACT I and IMPACT II. The IMPACT I Phase III trial reached its target enrollment of 177 patients with Stage III/IV advanced ovarian cancer who have successfully completed front-line therapy.
Two identical Phase III double-blind placebo controlled trials are currently being conducted at over 60 sites across the U.S. The IMPACT II trial continues to enroll patients. The enrollment target for each trial is 177 patients. The primary endpoint for each trial is time-to-relapse comparing OvaRex MAb and placebo with relapse as the endpoint.
OvaRex MAb (oregovomab), is a monoclonal antibody that has a high degree of specificity to a tumor associated antigen that is over-expressed by the majority of late-stage ovarian cancer patients. The drug has received both orphan-drug designation and fast-track status by the FDA.