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news.ViRexx Medical has reported that preliminary analysis of results from the two Phase III clinical trials of OvaRex MAb for the treatment of advanced ovarian cancer showed that the studies failed to reach statistical significance.
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The two identical Phase III trials, Impact I and Impact II, were randomized, double-blind, placebo-controlled trials conducted at over 60 centers across the US. The studies enrolled 367 ovarian cancer patients and assessed the efficacy of OvaRex mono-immunotherapy during the so-called ‘watchful waiting’ period following front-line carboplatin-paclitaxel based chemotherapy.
The studies demonstrated no difference between active (standard of care followed by OvaRex MAb) and control (standard of care followed by placebo) treatment arms. The results of Impact I and Impact II were consistent with each other.
The trials were conducted by ViRexx’s licensing partner, Unither Pharmaceuticals, a subsidiary of United Therapeutics. The program sought to confirm data observed in a subset analysis of a prior randomized Phase II study, which suggested the potential of OvaRex MAb to extend the time to disease relapse among patients who had successfully completed front-line therapy. The studies were well balanced in terms of patient demographics and the safety profile was similar between active and control populations.
Darrell Elliott, executive chairman and CEO of ViRexx, said: “Despite this setback for the OvaRex MAb, we have confidence in our three earlier stage programs, that are based upon two platform technologies separate from OvaRex MAb, specifically T-ACTand Chimigen, and that warrant continued development.”