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Applies to -- BICO
Biocontrol Technology, Inc. Subsidiary, IDT, Receives FDA Approval to Continue Lung Cancer Study at the University of Texas Medical Branch at Galveston
Biocontrol Technology, Inc. Subsidiary, IDT, Receives FDA Approval to
Continue Lung Cancer Study at the University of Texas Medical Branch at
Galveston
Biocontrol Technology, Inc. (OTC Bulletin Board: BICO) 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.
WEBSITE: www.bico.com
INVESTOR RELATIONS NEWSLINE NUMBER: 1-800-357-6204
SOURCE Biocontrol Technology, Inc.
(C) 2000 PR Newswire. All rights reserved.
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CONTACT: Investors, Diane McQuaide, 412-429-0673, or fax, 412-279-9690,
or Media, Susan Taylor, 412-429-0673, or fax, 412-279-5041, both of Biocontrol
Technology
KEYWORD: Pennsylvania
Texas
Indiana
INDUSTRY KEYWORD: BIO
MTC
URL: bico.com |
