***BICO FDA APPROVAL!!!!Biocontrol Technology, Inc. Subsidiary, IDT, Receives FDA Approval to Continue Lung Cancer Study at the University of Texas Medical Branch at Galveston
PITTSBURGH, Feb. 17 /PRNewswire/ -- Biocontrol Technology, Inc. (OTC Bulletin Board: BICO - news) announced today that its subsidiary, IDT, Inc., in conjunction with HemoCleanse, Inc. located in Lafayette, Indiana, has received FDA approval and Institutional Review Approval from the University of Texas Medical Branch at Galveston to continue a human clinical trial to treat patients with non-small cell lung cancer (NSCLC).
The clinical trial will utilize the ThermoChem technology and disposables to deliver Perfusion-Induced Systemic Hyperthermia (PISH), a therapy in which core body temperature is raised to 42 degrees C (107.6 degrees F) for two hours by direct extracorporeal (outside of the body) heating of the blood. Non-small cell lung cancer is a combination of at least three malignant cell structures found in the tissues of the lungs. Lung cancer remains a major cause of cancer morbidity and mortality in the United States.
IDT completed the first phase of the FDA approved study, which involved five patients in July 1998. That phase of the study involved patients with Stage IV non-small cell lung cancer where cancer had spread to other parts of the body. Results of that study are pending publication.
In this most recent approval, the FDA allowed Stage IIIb patients to be included. Stage IIIb is usually non-operative cancer that has spread to the chest wall or diaphragm near the lung or cancer that has spread to the lymph nodes in the area that separates the two lungs or to the lymph nodes on the other side of the chest or in the neck.
The objective of the clinical trial is to evaluate the ThermoChem technology as a delivery system for Perfusion-Induced Systemic Hyperthermia in the treatment of non-small cell lung cancer with regard to patient selection, tumor response, patient performance status, and patient survival.
In Perfusion-Induced Systemic Hyperthermia, the ThermoChem technology is composed of the ThermoChem-HT System(TM) and ThermoChem-SB System(TM). The ThermoChem-HT System heats and circulates the blood while maintaining core body temperature, and ThermoChem-SB System balances blood chemistries on a ``real-time' basis and removes toxins from the blood. The Company believes this interface between two systems is essential to safely deliver Perfusion-Induced Systemic Hyperthermia.
IDT has been developing the ThermoChem technology as a safe delivery system for whole body and regional hyperthermia since 1992. The FDA recently cleared the ThermoChem-HT System for marketing where the intended use is to raise the core temperature of the peritoneum to 42 degrees C (107.6 degrees F) by continuously lavaging (bathing) the peritoneum with sterile solution. Intraperitoneal hyperthermia is part of an operative procedure used to treat patients with advanced ovarian and gastrointestinal cancer.
Biocontrol Technology has its corporate offices in Pittsburgh, PA, and is involved in the development and manufacture of biomedical devices and environmental products. IDT, Inc., a subsidiary of Biocontrol also located in Pittsburgh, PA, holds exclusive worldwide marketing rights to the ThermoChem-HT technology and related disposables for regional hyperthermia and the ThermoChem technology and related disposables for whole body hyperthermia.
This press release contains statements of a forward-looking nature. Shareholders and potential investors are cautioned that such statements are predictions and actual events or results may vary significantly. |
