BSD Medical Reports Seminal Study Published in The Lancet Oncology Demonstrates Impressive Long-Term Results from Hyperthermia Treatment of Children and Adolescents with Recurrent or Refractory Germ Cell Tumors
Seminal study shows significantly improved survival from the addition of hyperthermia to chemotherapy for children and adolescents with recurrent germ cell tumors
Study published in The Lancet Oncology, the premier journal for the highest quality oncology research
BSD-2000 Hyperthermia System activated chemotherapy drugs that had previously failed these patients
SALT LAKE CITY--(BUSINESS WIRE)-- BSD Medical Corporation (BSD) (NAS: BSDM) announced today that The Lancet Oncology has published the results of a Phase II clinical study of hyperthermia, using the BSD-2000 Hyperthermia System (BSD-2000), combined with chemotherapy and tumor resection to treat malignant germ cell tumors in children and adolescents, "Regional deep hyperthermia for salvage treatment of children and adolescents with refractory or recurrent non-testicular malignant germ-cell tumours: an open-label, non-randomised, single-institution, phase 2 study." (Rüdiger Wessalowski et al.; The Lancet Oncology, Early Online Publication, July 1, 2013, doi: 10.1016/S1470-204570271-7.) The Lancet Oncology is the premier worldwide journal for the highest quality oncology research.
The published study demonstrated an objective tumor reduction in 86% of the patients, with a 5-year overall survival rate of 72%, which is unmatched by any other clinical report on recurrent childhood malignant germ-cell tumors. The study was conducted in the renowned University Paediatric Oncology Clinic in Dusseldorf, Germany. This clinical study was unique in that the patients received the identical chemotherapy regimen that is delivered as first-line treatment at a 20% reduced dose; thus, the only variable in the treatment was hyperthermia using the BSD-2000 Hyperthermia System. This seminal study showed that hyperthermia activated chemotherapy drugs that had previously failed these patients.
Forty-four patients aged 7 months to 21 years who had either recurrent tumors or tumors that were resistant to chemotherapy (refractory) were treated with hyperthermia, combined with cisplatin, etoposide, and ifosfamide (PEI chemotherapy), to reduce the tumor size to allow surgical resection of the residual tumor.
The researchers stated that, "In conclusion, we report the long-term results of a salvage protocol for paediatric patients with refractory or recurrent malignant germ-cell tumours; this protocol allows clinicians to provide a long-term cure for most of these patients with poor prognosis. These encouraging results for local tumour control, which is essential for a long-term cure, strongly suggest that the use of microwave-induced regional deep hyperthermia at temperatures of 41-43°C in combination with standard platinum-based chemotherapy should be introduced soon after initial treatment failure. This regimen has the potential to become a first-line treatment for tumours with locally difficult characteristics."
Rüdiger Wessalowski MD, author and Associate Professor at the Paediatric Oncology Clinic, Haematology and Immunology, Centre for Child and Adolescent Health, Heinrich-Heine University, Dusseldorf, Germany, led the multidisciplinary research team from the authoritative MAKEI study group. Other researchers included O Mils, V Friemann, O Kyrillopoulou, J Schaper, C Matuschek, U Göbel and R Willers of Heinrich-Heine University; DT Schneider of Pediatric Clinic Dortmund City Hospital; K Rothe of Charité-Virchow-Klinikum, I Leuschner of Institute of Pathology, UMS Kiel; S Schönberger of University Children's Hospital Bonn; and G Calaminus of University Children's Hospital Münster. All participating institutions are located in Germany.
About Heinrich-Heine University, Dusseldorf, Germany
The University Paediatric Oncology Clinic at Dusseldorf has taken the lead on multiple national and international studies designed to optimize pediatric oncology therapy. For more than 14 years the renowned Dusseldorf Pediatric Oncology Department has pioneered the application of hyperthermia therapy for treating children's cancers using a BSD-2000 for the treatment of soft tissue sarcomas and germ cell tumors.
About The Lancet Oncology
The Lancet is the world's longest running and leading medical journal. The Lancet is 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 is The Lancet's oncology journal that publishes the highest quality original research relevant to clinical cancer specialists worldwide. The Lancet Oncology is the leading clinical research journal in oncology and is in the top 0.5% of all scientific journals. Between the first online publication in 1996 and today, over 1.8 million users have registered at thelancet.com.
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 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.
This press release may be deemed to contain forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including the expected use of proceeds relating to the recently completed offering. Readers are cautioned that these forward-looking statements are only predictions and may differ materially from actual future events or results due to a variety of factors, including, among other things, the demand for the Company's products, the ability of the Company to produce the products to meet the demand, global economic conditions and uncertainties in the geopolitical environment and other risk factors set forth in the Company's most recent reports on Form 10-K and Form 10-Q. Any forward-looking statements in this release are based on limited information currently available to the Company, which is subject to change, and the Company will not necessarily update the information.
BSD Medical Corporation
William (Bill) S. Barth, 801-972-5555
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