SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
___________________
Date of Report (Date of earliest event reported) June 4, 1998
BIOCONTROL TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
Pennsylvania 0-10822 25-1229323
(State of other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
300 Indian Springs Road, Indiana, Pennsylvania 15701
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (412) 349-1811
_________________________________________________________________
(Former name or former address,
if changes since last report.)
Item 1. Change in Control of Registrant.
Not applicable.
Item 2. Acquisition or Disposition of Assets.
Not applicable.
Item 3. Bankruptcy or Receivership.
Not applicable.
Item 4. Changes in Registrant's Certifying Accountant
Not applicable.
Item 5. Other Events.
On June 4, 1998 Biocontrol Technology, Inc.
(NASDAQ:BICO) announced today that its subsidiary, IDT, Inc.
in conjunction with HemoCleanse, Inc. has received an Investigational
Device Exemption (IDE) from the FDA to conduct a human study utilizing
the ThermoChem-HT and related disposables for regional hyperthermia
as part of an aggressive combined therapy to include surgery and
intraperitoneal hyperthermic chemotherapy (IPHC) for the treatment of
patients with advanced gastrointestinal and ovarian cancers.
Item 6. Resignation of Registrant's Directors.
Not Applicable
Item 7. Financial Statement, Pro Forma Financial Information
and Exhibits.
(a) Financial Statements and Businesses Acquired - Not
Applicable.
(b) Pro Forma Financial Information - Not Applicable.
(c) Exhibits - Press Release.
SIGNATURES
Pursuant to the requirement of the Securities Exchange Act
of 1934, the Registrant has duly caused this Report to be signed
on its behalf by the undersigned hereunto duly authorized.
BIOCONTROL TECHNOLOGY, INC.
by /s/ Fred E. Cooper
Fred E. Cooper, CEO
DATED: June 4, 1998
BICO
BIOCONTROL TECHNOLOGY, INC
2275 Swallow Hill Road, Building 2500
Pittsburgh, PA 15220
Press Release
Release: Immediate
For More Information, Call:
Investors Media
Diane McQuaide Susan Taylor
1.412.429.0673 phone 1.412.279.9455 phone
1.412.279.9690 fax 1.412.279.9447 fax
FDA APPROVES STUDY FOR ADVANCED
GASTROINTESTINAL AND OVARIAN CANCERS
Pittsburgh, PA - June 4, 1998 - Biocontrol Technology, Inc.
(Nasdaq:BICO) announced today that its subsidiary, IDT, Inc. in
conjunction with HemoCleanse, Inc. has received an
Investigational Device Exemption (IDE) from the FDA to conduct a
human study utilizing the ThermoChem-HT and related disposables
for regional hyperthermia as part of an aggressive combined
therapy to include surgery and intraperitoneal hyperthermic
chemotherapy (IPHC) for the treatment of patients with advanced
gastrointestinal and ovarian cancers.
The study is approved to be conducted at the Comprehensive
Cancer Center of Wake Forest University (CCCWFU) where (IPHC) has
been under investigation as a therapy for disseminated
intraperitoneal cancer since 1992. According to Brian Loggie,
M.D., the principal investigator of the proposed studies, "Our
prior experience with this technique suggests that it is
effective in controlling malignant ascites and may prolong
survival in patients with disseminated intraperitoneal cancer.
The lack of an FDA-approved device for administering the heated
chemotherapy has prevented this technique from being more widely
available."
The outlook for patients with advanced gastrointestinal and
ovarian cancers that has disseminated to the peritoneal cavity is
grim. There is no effective standard treatment and patient
survival is poor.
The goal is to make IPHC a standard therapy in the treatment
of advanced gastrointestinal and ovarian cancers. The combined
therapy includes surgical tumor debulking with intraperitoneal
hyperthermic chemotherapy (IPHC), which utilizes the ThermoChem-
HT to circulate and heat fluid containing the chemotherapy drug
throughout the peritoneal cavity. In order to disseminate this
new technique to the surgical oncology community, a standardized
device had to be developed that could safely and simply be used
for intraperitoneal hyperthermic perfusion of chemotherapy
agents.
The ThermoChem-HT, a component of the ThermoChem System
utilized for regional hyperthermia, is being developed under the
ISO9001, which is a comprehensive standard covering design,
manufacturing, installation and servicing systems. Upon
completion of the ThermoChem-HT under ISO standards, a technical
file with clinical data will be submitted to a European Notified
Body to receive a CE Mark. Placement of a CE mark signifies that
the device meets the requirements for distribution into the
European community.
The ThermoChem-HT will be manufactured by Biocontrol
Technology, Inc. at its Indiana, PA manufacturing facility.
Human studies are ongoing utilizing the ThermoChem System
under a previously approved FDA Investigational Device Exemption
for treatment of metastatic non-small cell lung cancer at the
University of Texas Medical Branch at Galveston.
In a previously submitted 510(K) to market the ThermoChem-HT
in the United States, the FDA could not determine if the
ThermoChem-HT was substantially equivalent to legally marketed
predicate devices and suggested an IDE to obtain clinical data.
Biocontrol Technology, Inc. has its corporate offices in
Pittsburgh, PA and is involved in the development and manufacture
of biomedical devices and environmental products.
