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, firstname.lastname@example.org), 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 www.BSDMedical.com.
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