BSD Medical Hyperthermia Reports Initiation of Clinical Study Using Hyperthermia & Proton Therapy to Treat Patients with Soft...
July 15 2014 - 8:15AM
Business Wire
BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD)
(www.BSDMedical.com), a leading provider of medical systems that
utilize heat therapy to treat cancer, today reported initiation of
a Phase I/II study (HYPROSAR) using hyperthermia, delivered using
either the BSD-2000 Hyperthermia System (BSD-2000) or the BSD-500
Hyperthermia System (BSD-500), combined with proton radiotherapy to
treat patients with unresectable soft tissue sarcoma. The clinical
study has been designed in joint cooperation with Kantonsspital
Aarau, Paul Scherrer Institute, Villigen, Uniklinik Balgrist,
Zurich, and University Hospital, Zurich. The Phase I/II study will
include 28 adult patients with primary and unresectable soft tissue
sarcomas of extremities and trunk (excluding abdominal tumors). The
trial has been registered at ClinicalTrials.gov (NCT01904565) and
is open for patient enrollment.
The researchers announced the study initiation at the European
Society for Hyperthermic Oncology (ESHO) Annual Conference. Dr.
N.R. Datta presented the basis for the study,
"Thermoradiobiological basis of ''HYPROSAR'': A clinical trial with
hyperthermia and proton radiotherapy in unresectable soft tissue
sarcoma." During the presentation, Dr. Datta stated that studies
have demonstrated that hyperthermia increases the efficacy of
radiation with minimal morbidity, is especially cytotoxic for large
bulky tumors, and prevents the repair of radiation induced DNA
damage. He also reported that proton beam radiotherapy has superior
physical dose distribution profiles, as compared to conventional
radiotherapy. Datta concluded, "Consequently, for unresectable
primary and recurrent soft tissue sarcomas, the
thermoradiobiological and physical advantages of hyperthermia and
proton beam radiotherapy could be expected to produce a greater
tumour regression, higher tumour downstaging, superior
resectability with organ and limb preservation and improved
survival outcome without significant treatment related
morbidity."
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.
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. 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.
Financial ProfilesTricia Ross,
310-622-8226tross@finprofiles.com