BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced the publication of results from a clinical study on advanced pancreatic cancer using the BSD-2000 Hyperthermia System (BSD-2000). The study, "Gemcitabine and cisplatin combined with regional hyperthermia as second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer", (Int J Hyperthermia. 2013;29:8-16) reported the results of a retrospective analysis of 23 patients with advanced or metastatic pancreatic cancer who had relapsed after first-line chemotherapy treatment. The researchers, Tschoep-Lechner, et al., reported that hyperthermia, delivered using the BSD-2000, combined with gemcitabine and cisplatin resulted in low toxicity and high feasibility, even in these study patients who had a very negative prognosis and no standard treatment options. The researchers also reported that, despite the intrinsic limitation of a small retrospective analysis, the results suggested clinical efficacy of hyperthermia combined with gemcitabine and cisplatin whereas gemcitabine and cisplatin without hyperthermia does not seem to provide a significant benefit in patients with advanced pancreatic cancer.
In order to acquire additional data, the researchers are currently conducting a multicenter randomized Phase III study on the use of gemcitabine and cisplatin combined with hyperthermia compared to gemcitabine alone to treat postoperative pancreatic cancer. The study, which will accrue 332 patients, is led by the Department of Medical Oncology, Klinikum Grosshadern, Munich University Medical School, Munich, Germany, with Rolf D. Issels MD PhD as principal investigator. Participating centers for patient accrual include Klinik Bad Trissl, Schlossbergklinik Oberstaufen, Erlangen UMS, Tübingen UMS, Düsseldorf UMS and Charité UMS Berlin, all Germany.
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 for both genders. Worldwide, there are approximately 278,684 patients per year diagnosed with pancreatic cancer. 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. The risk of developing pancreatic cancer increases as people age.
About the BSD-2000 Hyperthermia System
The BSD-2000 – developed and patented exclusively by BSD – delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy. The BSD-2000 creates a central focusing of energy that can be electronically focused to target the shape, size and location of the tumor, thus providing dynamic control of the heating delivered to the tumor region. The BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the U.S. Food and Drug Administration (FDA) for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy. The BSD-2000 also has CE (Conformité Européenne) Marking approval for the commercial sale in Europe. CE Marking approval is also recognized in many countries outside of the EU.
About BSD Medical Corporation
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy, which is 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 several 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 employ precision-guided microwave energy to ablate (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 and clearances 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.