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.
The study is scheduled to open for patient enrollment April 1, 2012. The following clinical sites will initially participate in the clinical study: Klinikum Grosshadern of Ludwigs-Maximilans-Universität München, Klinik Bad Trissl Oberaudorf, Rotkreuzkrankenhaus München, Universitätsklinikum Düsseldorf, and Universitätsklinikum Tübingen. These sites all utilize the BSD-2000 Hyperthermia System.
Pancreatic cancer is one of the deadliest and most difficult to treat cancers and is the fourth leading cause of cancer-related death in the U.S. and throughout the world. There will be an estimated 44,000 Americans and 60,000 Europeans diagnosed with pancreatic cancer during 2012. The median survival is approximately 6 months for patients with metastatic disease and 10 months for patients with locally advanced disease. Advanced pancreatic cancer patients currently have few treatment options.
About the European Society for Hyperthermic Oncology
ESHO was organized in 1984 as a professional society to promote research relating to the use of hyperthermia in cancer therapy and to facilitate the exchange of information among multiple disciplines regarding the study of heat in the treatment of cancer.
About BSD Medical Corporation
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radiofrequency (RF) and microwave energy. BSD’s product lines include both hyperthermia and ablation treatment systems. BSD’s hyperthermia cancer treatment systems, which have been in use for many years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy. BSD’s microwave ablation system has been developed as a stand-alone therapy to ablate and destroy soft tissue. The Company has developed extensive intellectual property, multiple products in the market and established distribution in the United States, Europe and Asia. Certain of the Company’s products have received regulatory approvals in the United States, Europe and China. For further information visit BSD Medical's website at www.BSDMedical.com.
Statements contained in this press release that are not historical facts are forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date on which such statements are made, and the Company undertakes no obligation to update such statements to reflect events or circumstances arising after such date.