BSD Medical (BSDM) Initiates BSD-2000 Phase III

BSD Medical Corporation (Nasdaq: BSDM) reports initiation of a randomized, multicenter, Phase III clinical study using the BSD-2000 Hyperthermia System to deliver hyperthermia in combination with chemotherapy for the treatment of pancreatic cancer patients. The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology (ESHO), will compare hyperthermia with chemotherapy (gemcitabine plus cisplatin) to chemotherapy (gemcitabine) alone. Patients will be randomized following standard surgical resection of the tumor. The coordinating investigator is Rolf D. Issels, MD PhD, Department of Medical Oncology, Klinikum Grosshadern, Munich University Medical School, Munich, Germany.

The researchers had previously reported data from a Phase II study that utilized chemotherapy and hyperthermia, delivered using the BSD-2000 Hyperthermia System, to treat 21 inoperable pancreatic cancer patients who were resistant to or had failed previous chemotherapy gemcitabine treatments, a patient population with a dire prognosis. 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.

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