OTTAWA, Canada, March 23, 2011 /PRNewswire/ -- Nordion Inc. , a leading provider of products and services to the global health science market, today announced that it has received U.S. Food and Drug Administration (FDA) approval to conduct a Phase III clinical trial for TheraSphere(R) under an Investigational Device Exemption (IDE) to evaluate the safety and effectiveness of TheraSphere treatment in colorectal cancer patients whose disease has metastasized to the liver.

This randomized Phase III clinical trial, known as the EPOCH study, will take place at up to 30 sites worldwide, with a target enrolment of approximately 350 patients. The Principal Investigator is Dr. Mary Mulcahy of Northwestern University in Chicago, IL.

The trial will examine a number of safety and efficacy endpoints in patients who have developed liver tumours from colorectal cancer and who have failed first-line chemotherapy. Participants in the treatment group will receive both TheraSphere and second-line chemotherapy, while patients in the control group will only receive the chemotherapy regimen. The Company intends to design the trial to comply with all FDA and institutional review board requirements in the U.S. and to meet all relevant regulatory requirements for the study of an investigational device in other countries.

"The goal is to investigate whether TheraSphere used in combination with chemotherapy can offer patient outcome advantages that are superior to those of chemotherapy alone," explained Dr. Mulcahy.

According to the U.S. National Cancer Institute, colorectal cancer (CRC) is the third most common cancer in both men and women. An estimated 60 percent of CRC patients will eventually develop liver tumours. Most deaths associated with CRC are due to inoperable liver tumours.

"The EPOCH trial will help determine TheraSphere's clinical utility in combination with chemotherapy, and further advance our knowledge about TheraSphere's potential benefit to patients with liver metastases from colorectal cancer," said Dr. Peter Covitz, Nordion's Senior Vice-President of Innovation.