Theorem Clinical Research receives contract to conduct Nordion's TheraSphere Phase III trials

Jun 16 2011

Experienced CRO Provides Implementation Services for TheraSphere® Clinical Trials

Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services to the global health science market, today announced that Theorem Clinical Research, previously Omnicare Clinical Research, a full service Contract Research Organization (CRO) has been awarded the contract to conduct Nordion's recently announced TheraSphere Phase III clinical trials for the treatment of primary and metastatic liver cancers - STOP-HCC and EPOCH.

During the multi-year contract, Theorem Clinical Research will provide clinical trial implementation services which include clinical data management, statistical analysis, monitoring, and administrative expertise to support the conduct of the studies.  The trials are designed to evaluate the safety and effectiveness of TheraSphere.

In March 2011, the U.S. Food and Drug Administration approved Nordion's clinical trial applications for both primary and secondary liver cancer.  The trial for primary liver cancer currently envisages approximately 400 patients at up to 40 sites around the world.  The secondary liver cancer trial is expected to include approximately 350 patients at up to 30 sites worldwide.