Phase III BSD-2000 Hyperthermia System-chemotherapy combination study for pancreatic cancer initiated

BSD Medical Corporation (NASDAQ:BSDM) reports initiation of a randomized, multicenter Phase III clinical study using the BSD-2000 Hyperthermia System in combination with chemotherapy for the treatment of pancreatic cancer patients after R0/R1 surgical resection of their tumor (complete removal or only microscopic tumor remaining). The coordinating investigator is Rolf D. Issels, MD PhD, Department of Medical Oncology, Klinikum Grosshadern, Munich University Medical School, Munich, Germany. The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology (ESHO), will compare hyperthermia with chemotherapy (gemcitabine) to chemotherapy (gemcitabine) alone.

The Phase III study was initiated following completion of a Phase II study that utilized chemotherapy and hyperthermia to treat 21 inoperable pancreatic patients who were resistant to or had failed previous chemotherapy gemcitabine treatments, a patient population with a dire prognosis. There was one complete response (complete disappearance of the tumor), 3 partial responses (more than 50% tumor reduction), and 7 patients with stable disease (no tumor growth). The study results demonstrated a low toxicity rate and an overall survival of 16.9 months. By comparison, the median survival for inoperable pancreatic cancer patients after gemcitabine treatment is only 6 months. The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology (ESHO), will compare hyperthermia with chemotherapy (gemcitabine) to chemotherapy (gemcitabine) alone.

Pancreatic cancer is one of the deadliest and hardest to treat cancers and is the fourth leading cause of cancer-related death. There were an estimated 42,470 Americans and 60,000 Europeans diagnosed with pancreatic cancer during 2009 and approximately 80% are inoperable. The median survival period from the time of diagnosis until death is 3.5 to 6 months, depending on treatment, and less than 5 percent survive to five years. Advanced pancreatic cancer patients currently have few treatment options.

The study is scheduled to open for patient enrollment in March 2010. The following clinical sites will participate in the clinical study: Klinikum Grosshadern of Ludwigs-Maximilans-Universität München, HELIOS Schlossbergklinik Oberstaufen, Rotkreuzkrankenhaus München, Universitätsklinikum Düsseldorf, Klinikum Mannheim of Heidelberg University Medical School, Universitätsklinikum Erlangen, Universitätsklinikum Freiburg, Universitätsklinikum Tübingen, and Charité University Medical School Berlin (all Germany); Kantonsspital Aarau AG (Switzerland); and Ospedale Borgo Trento Verona (Italy).