Clinical Studies of OvaRex in Advanced Ovarian Cancer Fail to Meet Primar...( Preliminary Analysis Demonstrates ...),Health

Preliminary Analysis Demonstrates Studies Failed to Reach Statistical

Significance

SILVER SPRING, Md. and WELLESLEY HILLS, Mass., Dec. 5 /PRNewswire- FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) and its wholly- owned subsidiary, Unither Pharmaceuticals, Inc., announced today the completion of their two pivotal trials of OvaRex(R) MAb for the treatment of advanced ovarian cancer. Preliminary analysis demonstrates that the studies failed to reach statistical significance.

The identical studies, known as IMPACT I and II (IMunotherapy Pivotal ovArian Cancer Trial), were randomized, double-blind, placebo-controlled trials conducted at over 60 centers across the United States. 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 program sought to confirm data observed in a subset analysis of a prior randomized phase II study, which suggested the potential of OvaRex 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. The studies demonstrated no difference between active (standard of care followed by OvaRex) and control (standard of care followed by placebo) populations. The results of IMPACT I and II were consistent with each other. There were no statistically significant differences in safety profiles and the quality of life between the active and control groups.

Further review and analysis of the IMPAC
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