OvaRex Fails to Meet Endpoint in Trial

United Therapeutics and its subsidiary Unither Pharmaceuticals have completed two trials of OvaRex MAb for the treatment of advanced ovarian cancer, and preliminary analysis demonstrates the studies failed to reach statistical significance.

The randomized, double-blind, placebo-controlled IMPACT I and II trials enrolled 367 patients and assessed the efficacy of OvaRex (oregovomab) mono-immunotherapy following front-line carboplatin-paclitaxel based chemotherapy.

Study data demonstrated no difference between the active (standard of care followed by OvaRex) and control (standard of care followed by placebo) populations.

OvaRex is one of five investigational immunotherapeutic monoclonal antibodies Unither Pharmaceuticals licensed from AltaRex Medical. Based on the preliminary results from the IMPACT trials, Unither Pharmaceuticals intends to terminate the license agreement and cease development of the entire platform of antibodies, according to United Therapeutics.