BSD Medical Reports Initiation of a Clinical Study to Treat Recurrent Rectal
Cancer with the BSD-2000
SALT LAKE CITY -- December 17, 2012
BSD Medical Corporation (NASDAQ: BSDM) reports initiation of a Phase I/II
clinical study (HyRec-Trial) using the BSD-2000 Hyperthermia System (BSD-2000)
to deliver hyperthermia in combination with chemotherapy (5-FU/oxaliplatin)
and radiotherapy for the treatment of patients with locally recurrent rectal
cancer. The multicenter study, which will be sponsored by the University of
Erlangen Medical School (Erlangen), will evaluate the feasibility and the
efficacy of adding hyperthermia to a multimodal treatment regimen that
includes potent new chemotherapeutic agents such as oxaliplatin. The study
will initially enroll 59 patients. If the study parameters are met, a
randomized Phase III clinical trial will be initiated. The HyRec-Trial has
been approved by the German Cancer Society.
The coordinating investigator for the study is Oliver Ott, MD, Associate
Professor, Department of Radiation Oncology, Erlangen. Erlangen was
instrumental in establishing preoperative chemotherapy and radiation as the
current standard of care for treating stage II and III rectal cancer and the
treatment recommended by the National Comprehensive Cancer Network (NCCN)
Rectal Cancer Treatment Guidelines (2.2013). The NCCN Clinical Practice
Guidelines in Oncology are the recognized standards for clinical treatment
policy in the oncology community. Rolf Sauer, MD, who is Professor Emeritus at
Erlangen, led the seminal German clinical studies, which were published in
2004 and 2012, that resulted in establishing the standard of care for stage II
and III rectal cancer. Dr. Sauer is also the initiator and coordinator of the
Erlangen based Atzelsberg Circle for hyperthermia, which was established in
2007 to establish the benefit of hyperthermia through definitive clinical
studies. Dr. Sauer is a leading expert in the treatment of cancer, serves as
the editor of the longest running scientific publication in radiation
oncology, Strahlentherapie & Onkologie, and has been awarded the Order of
Merit of the German Republic as well as the German Cancer Award. He is also an
honorary member of the Radiological Society of North America.
Two randomized studies have demonstrated that radiotherapy combined with
chemotherapy and deep hyperthermia can improve response, local control and
survival rates in certain patients with rectal cancer. Berdov et al.
("Thermoradiotherapy of patients with locally advanced carcinoma of the
rectum." Int J Hyperthermia. 1990) reported on 115 patients with rectal cancer
who received radiotherapy alone (n=59) and radiotherapy combined with
hyperthermia (n=56). Complete and partial remission rates (16% vs. 2% and 54%
vs. 34%; P<0.05) as well as overall survival rates at five years (36% vs. 7%;
P<0.05) were significantly improved in the hyperthermia group. Rau et al.
("Stellenwert der Hyperthermie für die chirurgische Onkologie."
Viszeralchirurgie 2002) reported on a randomized trial with 137 patients with
rectal cancer who were treated with neoadjuvant radiochemotherapy combined
with (n=69) or without (n=68) hyperthermia. Response (complete and partial
remission rates) was significantly better for the hyperthermia group (66% vs.
49%; P<0.05). Time to progression at three years was also better for the
hyperthermia group (66% vs. 49%; P<0.05).
Per the National Cancer Institute, colorectal cancer is the second leading
cause of death in the U.S. Per the World Health Organization, colorectal
cancer is a major cause of morbidity and mortality and the fourth most common
form of cancer worldwide. Almost half of colorectal tumors are located in the
rectum. According to the American Society of Colon and Rectal Surgeons, about
half of all patients with colorectal cancer will develop metastatic disease at
some point, and in most cases this disease will be fatal.
The study is open for patient enrollment. The following research institutions
will initially participate in the study: Universitätsklinikum Erlangen
(Principal Investigator: Associate Professor Oliver Ott, MD,
email@example.com), Universitätsklinikum Munich Grosshadern (Associate
Professor Lars Lindner, MD) and UMS Tübingen (Professor Daniel Zips, MD).
These sites all utilize the BSD-2000 Hyperthermia System.
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 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
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.
BSD Medical Corporation
Dennis Gauger, 801-972-5555
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