3/3/2004 Generex Biotechnology Working to Develop Diagnostic Kit for Early Detection
Company to Collaborate with Leading European Diabetes Centers for Clinical
Studies
TORONTO -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today
that its wholly-owned subsidiary, Antigen Express, hasis working to
developed a diagnostic kit for the early detection and screening of Type 1
diabetes in young children. The Company will shortly begin in vitro studies
aimed at identifying the immune mechanisms leading to the destruction of the
insulin producing cells of the pancreas and onset of Type 1 diabetes.
Antigen Express withwill partner for these studies with two leading European
diabetes centers, the University Campus Medico in Rome and St. Bartholomew's
Hospital in London.
The studies will focus on the role that Lymphocytes (T-cells) play in a
series of pancreatic antigens, the most common of which are GAD (glutamic
acid decarboxylase), IAA (tyrosine phosphatase) and IA (insulin). These
antigens have previously been measured by a number of investigators, but the
goal of Antigen Express is to identify and characterize the T-cells
themselves in order to design strategies to block their cytotoxic effects.
Antigen Express will work with itsthe European partners to characterize
these lymphocytes in order to establish a better screening parameter for
those at risk, earlier diagnosis and possible intervention.
Although Type 1 Diabetes Mellitus only constitutes 5 to 10% of all cases of
diabetes, it's impact can be acutely devastating, especially for the parent
of a young child affected by this disease. The best prevention has yet to be
determined, but scientific experts agree that high probability screening
plays an important role. This was highlighted by a front- page article by
Michael Waldholz in the Wall Street Journal on March 1, 2004 where he
addressed the issue and the efforts by a few investigators.
"We believe early detection plays a key role in treating Type 1 diabetes,"
said Anna E. Gluskin, President and Chief Executive Officer of Generex.
"Generex is a company focused on developing novel mechanisms to treat
diabetes in many ways. Our immunology program is the ideal compliment to our
flagship product Generex Oral-lyn, our novel buccal delivery insulin spray
formulation. This latest development will expand our diabetes franchise and
demonstrates the potential of Antigen Express in enhancing our solutions to
manage diabetes."
"The implications of this program are significant," said Dr. Gerald
Bernstein, Generex's Director of Medical Affairs. "While many are focused on
a cure for diabetes and new glucose measuring devices or an easier method to
deliver insulin, the solutions ultimately become more effective through
early detection. This program is designed to test children at early ages, so
that the disease management process can begin as soon as possible."
About Generex
Generex is engaged in the research and development of drug delivery systems
and technology. To date, it has focused on developing a platform technology
for the buccal delivery -- delivery to the oral cavity for absorption
through the inner mouth mucosa -- of drugs that historically have been
administered only by injection. Generex's buccal delivery technology has
application to a large number of drugs. Generex acquired Antigen Express in
August. 2003. The core platform technologies of Antigen Express comprise
immunotherapeutics for the treatment of malignant, infectious, allergic, and
autoimmune diseases.
This release and oral statements made from time to time by Generex
representatives concerning the same subject matter may contain "forward-
looking statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements can be identified by introductory words
such as "expects," "plans," "intends," "believes,"
"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
potential product applications, potential collaborations, product
development activities, clinical studies, regulatory submissions and
approvals, and similar operating matters. 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 others of which are not. Known risks and uncertainties include
those identified from time to time in the reports filed by Generex with the
Securities and Exchange Commission, which should be considered together with
any forward-looking statement. No forward- looking statement is a guarantee
of future results or events, and one should avoid placing undue reliance on
such statements. Generex claims the protection of the safe harbor for
forward-looking statements that is contained in the Private Securities
Litigation Reform Act.
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc.,
+1-212-732-4300, kensgro@ceocast.com, for Generex Biotechnology
+Corporation
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300,
kensgro@ceocast.com, for Generex Biotechnology Corporation
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