GENEREX BIOTECHNOLOGY ANNOUNCES SIGNIFICANT PROGRESS IN ITS CONTINUING CLINICAL TRIALS STUDIES SHOW SIGNIFICANT INCREASE OF INSULIN IN PLASMA Levels and A Significant Reduction of C-peptide Compared To Placebo
GENEREX BIOTECHNOLOGY ANNOUNCES SIGNIFICANT PROGRESS IN ITS CONTINUING
CLINICAL TRIALS STUDIES SHOW SIGNIFICANT INCREASE OF INSULIN IN PLASMA
Levels and A Significant Reduction of C-peptide Compared To Placebo
TORONTO, Jan 12, 2000 /PRNewswire via COMTEX/ -- Generex Biotechnology
Corporation (OTC Bulletin Board: GNBT) today announced that it has
completed short-term clinical trials of ORALIN/ORALGEN(TM) in healthy
volunteers. The trials on Type I diabetic patients and healthy
volunteers were conducted by Dr. Sherwyn Schwartz, the company's
principal U.S. Investigator and Director of The Diabetes and Glandular
Disease Clinic in San Antonio, Texas.
The study protocol conducted on healthy volunteers involved the
administration of oral insulin doses under fasting conditions. The
objective of the study was to evaluate ORALIN/ORALGEN's efficacy in
achieving a rise in plasma insulin and suppression of c-peptide in
healthy volunteers. The data from this trial were statistically
analyzed at the University of Toronto and indicated strong statistical
significance in comparison to the baseline value. The analysis resulted
in a rise in plasma insulin p<0.002, suppression of c-peptide p<0.004
and the suppression of glucose levels p<0.008, that is, the
administration of Oralin/Oralgen in healthy volunteers resulted in a
significant increase of insulin in plasma levels and a significant
reduction of c-peptide compared to the placebo.
Dr. Schwartz stated, "The results of this trial are very positive and
signify a significant breakthrough in alternative insulin delivery that
could lead to tremendous advancements in the treatment of diabetes."
Long term trials of Oralin/Oralgen on Type I and Type II diabetic
patients are ongoing in both Canada and the United States.
Generex Biotechnology Corporation is engaged in the research and
development of drug delivery systems and technologies. To date, the
Company has focused on developing a platform technology for the buccal
delivery (absorption through the inner cheek walls) of large molecule
drugs which, historically, have been administered only by injection.
The Company's first application for the technology is an insulin
formulation (ORALGEN in the United States and ORALIN in Canada and
elsewhere) that is administered as a fine spray into the oral cavity
using RAPID MIST, a lightweight hand held aerosol applicator. Phase II
clinical trials of the product are presently in progress in the US and
Canada.
Notice: This release and oral statements made from time to time by
Company representatives concerning the same subject matter may contain
so-called "forward-looking statements". These statements can be
identified by introductory words such as "expects," "plans," "will,"
"estimates," "forecasts," "projects" or words of similar meaning, and
by the fact that they do not relate strictly to historical or current
facts. Forward-looking statements frequently are used in discussing
regulatory submissions and approvals, development programs, etc. Many
factors may cause actual results to differ from forward-looking
statements, including inaccurate assumptions and a broad variety of
risks and uncertainties, some of which are known and other of which are
not. Not forward-looking statement is a guarantee of future results or
events, and one should avoid placing undue reliance on such statements.
SOURCE Generex Biotechnology Corporation
(C) 2000 PR Newswire. All rights reserved.
prnewswire.com
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CONTACT: Time Release Corporation, 800-391-6755, or fax, 416-364-8782;
or Jeffrey Volk of Wolfe Axelrod Weinberger Associates, 212-370-4500, or fax,
212-370-4505, or jeff@wolfeaxelrod.com, both for Generex
(GNBT)
GEOGRAPHY: New York
Ontario
INDUSTRY CODE: MTC
BIO
SUBJECT CODE: PDT
OTC
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