The Utah company said an earlier Phase II study that used chemotherapy and hyperthermia to treat 21 inoperable pancreatic cancer patients produced an overall patient survival rate of 16.9 months versus six months using chemotherapy alone.
The difference between a Phase II and Phase III study is that in the later patients will be assigned to the two treatment groups at random, said Dixie Sells, vice president of regulatory affairs at BSD Medical. "A Phase III study is considered the gold standard for clinical research."
The study is scheduled to open for patient enrollment on April 1. Researchers will be accepting patients from the United States, but they will have to travel to Germany for treatment, Sells said.
The coordinating investigator will be Rolf D. Issls, a doctor with the Department of Medical Oncology at the Munich University Medical School in Germany.
BSD Medical, whose shares are listed on the Nasdaq stock market and are trading in the $2.50 range, manufacturers hyperthermia systems that treat cancers using heat that is produced from focused radio-frequency and microwave energy.