SALT LAKE CITY--(BUSINESS WIRE)-- BSD Medical Corporation (“BSD” or “Company”) (NASDAQ: BSDM) today reported presentation of a clinical study being conducted at Duke University on the use of hyperthermia, delivered using the BSD-2000 Hyperthermia System, combined with chemotherapy to treat bladder cancer patients who have failed standard therapy. The clinical study abstract, titled “Pilot Study of External Hyperthermia and Intravesical Mitomycin-C to Treat Recurrent Bladder Cancer after Resection and Standard Adjuvant Therapy,” was presented by Zeljko Vujaskovic, MD, PhD, Duke University Medical Center (Duke), at the annual American Society of Clinical Oncology (ASCO) meeting, held in Chicago, Illinois, on June 4 to June 8, 2010.
Duke’s clinical study involves the use of hyperthermia combined with intravesical chemotherapy (mitomycin-C [MMC]) to treat patients who have recurrent bladder cancer following first-line therapy or who are not expected to respond to first-line therapy. The clinical study will evaluate the safety, tolerability, and clinical benefit of administering hyperthermia and MMC as second-line treatment. There is a significant need to develop better treatment strategies for the significant number of patients who fail first-line therapy. There are 61,240 new cases of bladder cancer each year, and up to 85% of these patients will have a recurrence of their disease.
Dr. Vujaskovic had previously reported the initial results of this study at the annual Society for Thermal Medicine (STM) meeting, held in Clearwater, Florida, on April 23 to April 26, 2010. Dr. Vujaskovic reported that the initial results showed promise for these patients. Duke has enrolled 11 patients. Seven of the nine patients who have been evaluated four weeks post-treatment had no evidence of disease following treatment. Seven patients have completed maintenance therapy, and six of these seven patients had no evidence of disease. The treatment has been well tolerated with no significant toxicity. The researchers stated at STM that “BSD 2000 heating system with Sigma Ellipse applicator is an effective and safe method of delivering local bladder hyperthermia to heat intravesical mitomycin-C within therapeutic temperature range of 40°C to 43°C.” Information regarding the Duke Study can be found at the clinical study registry website of the National Institutes of Health: http://www.clinicaltrials.gov/ct2/show/NCT00734994?term=bladder+cancer+AND+hyperthermia&rank=2.
Previous studies conducted on bladder cancer have demonstrated an improvement in overall survival, tumor response rates, and local tumor control from the addition of hyperthermia therapy, delivered using the BSD-2000 Hyperthermia System, to the standard treatment regimen. (M. Wittlinger, et al. “Quadrimodal treatment of high-risk T1 and T2 bladder cancer: Transurethral tumor resection followed by concurrent radiochemotherapy and regional deep hyperthermia.” Radiotherapy and Oncology, 93, 2009, 358.)
On December 11, 2009, the German Society of Radiation Oncology (DEGRO) issued a press release that stated that the addition of hyperthermia to standard radiation therapy (multi-modal therapy) is effective for patients with aggressive bladder cancer who want to avoid removal of their bladder. The press release stated that the addition of hyperthermia to standard radiotherapy and chemotherapy (radiochemotherapy) increases the number of patients who can be effectively treated without removal of the bladder.
About Duke Comprehensive Cancer Center
The Duke Comprehensive Cancer Center, established in 1972 as one of the original eight comprehensive cancer centers designated by the National Cancer Institute, is consistently ranked among the top programs for cancer care in the United States. Its more than 300 members include nationally-known leaders with scientific and clinical expertise in a broad range of programs including signature research in genomic sciences, vaccine development, cell-signaling studies, and unique treatments available only at the Preston Robert Tisch Brain Tumor Center. The Duke Comprehensive Cancer Center serves more than 7,000 new patients each year, seeking to help all of them live more robust and vibrant lives by accelerating the pace of discovery and offering personalized, compassionate care.
About the American Society of Clinical Oncology (ASCO)
ASCO is the world’s leading professional organization representing physicians who treat people with cancer. ASCO’s members set the standard for patient care worldwide and lead the way in carrying out clinical research aimed at improving the prevention, diagnosis, and treatment of cancer.
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 US. 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.
CONTACT:
BSD Medical Corporation, Salt Lake City
Dennis Gauger, 801-972-5555
Fax: 801-972-5930
[email protected]
KEYWORDS: United States North America Illinois Utah
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials General Health
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