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news.Unither Pharmaceuticals, a subsidiary of United Therapeutics, has completed enrollment of 177 patients in the first of two pivotal trials of OvaRex its investigational treatment for late stage ovarian cancer.
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OvaRex is an immunotherapeutic monoclonal antibody being developed for the treatment of stage III/IV advanced ovarian cancer following successful completion of front-line therapy.
The antibody targets CA125, a protein expressed in most ovarian cancers, and is designed to help patients’ immune systems recognize and more effectively fight their ovarian cancer.
The two identical phase III trials are designed to assess the time to disease relapse in patients diagnosed with late-stage ovarian cancer who achieved an optimal response to front-line chemotherapy treatment. The trials are being conducted at over 60 centers throughout the US.
All patients will remain in each trial until disease progression has occurred, with primary analysis occurring after both trials have recorded at least 118 relapse events.
“Achieving full enrollment… is an important step toward our efforts to confirm the positive findings found in a well-defined subset from an earlier phase II study and, as such, these studies are intended to support registration of OvaRex to treat advanced ovarian cancer,” said Dr Christopher Nicodemus, senior vice president, Clinical R&D at Unither Pharmaceuticals.