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SALT LAKE CITY, April 29, 2010—BSD Medical Corporation (BSD) (NASDAQ:BSDM) announced today that Lancet Oncology, the premiere worldwide journal for original oncology research, has published the results of a Phase III clinical study of hyperthermia, using the BSD-2000 Hyperthermia System, combined with chemotherapy for the treatment of high-risk soft-tissue sarcoma cancer (STS) patients, “Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study”. (The Lancet Oncology, Early Online Publication, 29 April 2010, doi:10.1016/S1470-2045(10)70071-1.)
The published study demonstrated improved overall survival if regional hyperthermia (HT) was added to chemotherapy (etoposide, ifosfamide, and doxorubicin [EIA]) treatment, for patients who received the complete treatment. The study also demonstrated that regional hyperthermia combined with chemotherapy (CT) improved tumor reduction, disease-free survival and time to disease progression.
The researchers stated that, “This randomised trial provides the first evidence that regional hyperthermia added to preoperative and postoperative chemotherapy is clinically more effective than chemotherapy alone in a specific population of patients with high-risk STS. This therapeutic strategy offers a new treatment option, and can be integrated in the multimodal treatment approach for these patients.” The researchers also stated that, “Importantly, adding regional hyperthermia prevented a considerable proportion of patients from developing progressive disease, compared with EIA alone (6.8% vs 20.6%).”
The study demonstrated that the addition of regional hyperthermia, using the BSD-2000 Hyperthermia System, to chemotherapy (EIA) resulted in a significant reduction in disease progression or death, with a median disease-free survival of greater than 120 months (i.e., the median is not yet reached) for the HT+ EIA group, as compared to 75 months in the EIA only group. Local tumor progression at 2 years was 19% for the HT+ EIA group, compared with 30% in the EIA only group. The addition of hyperthermia also more than doubled the proportion of patients whose tumors responded to chemotherapy (12.7% for the EIA only group vs. 28.8% for the HT+ EIA group (p=0·002).
The Phase III study involved 341 patients who were treated at leading research centers in Europe and the United States. All patients had locally advanced soft tissue sarcomas and were at high risk of recurrence and disease spread. Of the 341 patients, 169 were randomly assigned to receive hyperthermia along with chemotherapy (etoposide, ifosfamide, and doxorubicin [EIA]) and 172 were randomly assigned to receive EIA only.
“Head-to-head comparative trials are among the most important trials in oncology research, as they offer the best evidence for clinical acceptance of a therapy. The publication of this study in a prestigious peer-reviewed journal is a significant event in the evolution of hyperthermia. These compelling clinical study results are the outcome of many years of dedicated effort by leading scientists and physicians and represent a milestone in the clinical acceptance of BSD’s patented phased array thermal therapy technology,” stated Harold Wolcott, BSD’s President.
The following institutions were involved in the study: Klinikum der Universität München—Campus Grosshadern, München, Germany; Helmholtz Zentrum München—German Research Center for Environmental Health, München, Germany; Uniklinik Köln, Köln, Germany; Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands; Charité—Universitätsmedizin Berlin, Berlin, Germany; Haukeland University Hospital, Bergen, Norway; Department of Pathology, Rigshospitalet, Copenhagen, Denmark; Duke University Medical Center, Durham, NC, USA; Universitätsklinikum Düsseldorf, Düsseldorf, Germany; Universitätsklinik Graz, Graz, Austria; and Centre Leon Berard, Lyon, France. The study was funded by the Deutsche Krebshilfe, Helmholtz Association, EORTC, ESHO, and NIH.
About The Lancet Oncology
The Lancet is the world's longest running medical journal and one of the world's best-known, oldest, and most respected medical journals. The Lancet is an authoritative voice in global medicine and publishes high-quality clinical trials that will alter medical practice. The Lancet Oncology publishes original research relevant to clinical cancer specialists worldwide. Between the first online publication in 1996 and today, 1.8 million users have registered at thelancet.com.
About BSD Medical Corporation (www.BSDMedical.com)
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radio frequency (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, which the Company will introduce to the market this year, has been developed as a stand-alone therapy to employ precision-guided microwave energy to ablate (destroy) soft tissue. The Company has extensive intellectual property, multiple products in the market and well 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. The BSD-2000 is restricted to investigational use in the United States. For further information visit BSD Medical's website at www.BSDMedical.com.
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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.
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