Thursday February 17, 12:44 pm Eastern Time|
Company Press Release
SOURCE: Biocontrol Technology, Inc.
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
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
INVESTOR RELATIONS NEWSLINE NUMBER: 1-800-357-6204
SOURCE: Biocontrol Technology, Inc.
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