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) January 31, 1997
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 January 31, 1997, Biocontrol Technology, Inc.
(NASDAQ:BICO) announced that its subsidiary, IDT, Inc., in
conjunction with HemoCleanse, Inc. of West Lafayette, IN,
released the six-month results of HIV study patients which showed
reduction of patient viral levels. These patients participated
in the companies' July 1996 non-randomized study involving
extracorporeal whole-body hyperthermia (WBH), utilizing the
BioLogic-HR System and disposables for the treatment of HIV.
The results suggest WBH could extend the clinical effectiveness
of multi-drug therapies once a patient begins developing drug
resistance.
IDT has received Institutional Review Board approval
with a major hospital in Miami, FL to commence the companies' FDA-
approved three-site study involving a total of 60 patients.
In addition, research has extended abroad where a
European protocol entitled "Clinical Evaluation of HIV Infected
Patients Treated with Extracorporeal Whole Body Hyperthermia" to
involve 150 patients has been developed for a cooperative study
between Italian and German doctors, who will serve as project
coordinators with a leading medical school in Hannover, Germany.
Provided the study is approved, the project will purchase the
system and disposables necessary for the study.
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: January 31, 1997
BICO
BIOCONTROL TECHNOLOGY, INC.
2275 Swallow Hill Road, Bldg. 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
BIOCONTROL SUBSIDIARY, IDT, ANNOUNCES
SIX-MONTH RESULTS OF HIV CLINICAL TRIAL
Pittsburgh, PA - January 31, 1997 - Biocontrol Technology,
Inc. (Nasdaq:BICO) announced today that its subsidiary, IDT,
Inc., in conjunction with HemoCleanse, Inc. of West Lafayette,
IN, released the six-month results of HIV study patients which
showed reduction of patient viral levels. These patients
participated in the companies' July 1996 non-randomized study
involving extracorporeal whole-body hyperthermia (WBH) utilizing
the BioLogic-HT System and disposables for the treatment of HIV.
Four of the five patients involved were on triple-drug
therapies (one protease inhibitor and two nucleosides), while the
fifth patient was on a nucleoside alone. One patient on triple-
drug therapy had an undetectable viral load at pre-treatment and
remains undetectable six months after WBH treatment while
continuing drug therapy. Interestingly, two of the three
patients also on triple-drug therapy showed an upward trend in
their viral loads prior to treatment but now have lower viral
loads, as determined by bDNA ultrasensitive assay, six months
following WBH and remaining on drug therapy. The other patient
on triple-drug therapy showed only a slight increase in viral
load at six months post-treatment. The last patient on a single
nucleoside had a slightly lower viral load six months following
WBH treatment and remains on this drug therapy. Normally,
patients in this stage of the disease show an increased viral
load as the disease progresses.
These results suggest WBH could extend the clinical
effectiveness of multi-drug therapies once a patient begins
developing drug resistance. Milton Yatvin, Ph.D., Oregon Health
Sciences University in Portland, an early advocate of using WBH
to treat HIV infection, believes that "viral resistance to all
current anti-HIV drugs, including the protease inhibitors, will
eventually develop and result in reduced clinical efficacy of
drug regimen and subsequent disease progression. Because it is
unlikely that either virally infected cells or virus will develop
heat resistance, WBH could reduce a patient's burden of resistant
virus and extend the therapeutic usefulness of multi-drug
therapies."
IDT has received Institutional Review Board (IRB) approval
with a major hospital in Miami, FL, to commence the companies'
FDA-approved three-site study involving a total of 60 patients.
At this first site, the Clinical Investigator, who is a leading
Miami infectious disease physician specializing in HIV treatment,
has been selected and patients for the study will be taken from
the Miami area. It is anticipated that the study will begin
within the next 60 days.
In addition, research has extended abroad where a European
protocol entitled "Clinical Evaluation of HIV Infected Patients
Treated with Extracorporeal Whole Body Hyperthermia" to involve
150 patients has been developed for a cooperative study between
Italian and German doctors, who will serve as project
coordinators with a leading medical school in Hannover, Germany.
Provided the study is approved, the project will purchase the
system and disposables necessary for the study.
Biocontrol Technology, Inc. has its corporate offices in
Pittsburgh, Pennsylvania and is involved in the development and
manufacture of biomedical devices and environmental products.
IDT, Inc., also located in Pittsburgh, Pennsylvania, is a wholly-
owned subsidiary of Biocontrol, develops the hyperthermia
treatment procedure and holds exclusive worldwide marketing
rights to the BioLogic-HT System and related disposables.
