Pandemic Influenza Vaccine Development Accelerated at Generex
Biotechnology with Hire of Accomplished Senior Scientist


Novel Vaccine Technology Boosts T Helper Cell Responses to Asian
Bird Flu Influenza, to Aid Some Existing Vaccines and for Use as a
Stand-Alone Vaccine in Developing Countries

TORONTO, Aug. 16 Generex Biotechnology Corporation (Nasdaq:
GNBT) announced today that Antigen Express, Inc., its
wholly owned immunotherapeutics subsidiary, hired Dr. John
Zinckgraf, Ph.D. to accelerate development of a novel vaccine for
pandemic influenza.

Dr. Zinckgraf received his Ph.D. in Molecular and Cellular
Biology from the University of Connecticut where his primary
research focus was DNA vaccine
development and delivery. He tested novel DNA vaccines for HIV and
HBV, using
various inducible and constitutive promoters as well as different
polyadenlylation sequences. Such genetic elements can regulate
antigen
synthesis and consequently the magnitude of the immune response to a
vaccine.
Following his doctoral work, Dr. Zinckgraf was as a postdoctoral
fellow at
Epimmune, Inc. in San Diego, California where he pursued pre-clinical
development of several infectious disease vaccines, using the
company's DNA
vaccine minigene technology. Dr. Zinckgraf returned to the
University of
Connecticut as a postdoctoral scientist to develop vaccine delivery
systems
for foot-and-mouth disease virus, as well as development and
expression of
single-chain antibodies against chemical and tobacco carcinogens.
Dr. Zinckgraf was recruited to Antigen Express in view of his
extensive
experience and strong track record in advancing vaccine
technologies. Dr.
Robert Humphreys, Chief Scientific Officer of Antigen Express, Inc.,
said,
"John is an excellent scientist who was recommended with highest
enthusiasm by
his mentors as a creative and hard working immunologist. In a few
short
months, he has greatly advanced the pace of our programs in
influenza and is a
superb strategic planner and experimentalist."
Dr. Zinckgraf said, "I am pleased to join the Antigen Express
group of
scientists. The technology is novel and recognized by senior
academic and
corporate scientists. We are making rapid progress toward testing a
series of
Ii-Key/T-helper cell epitope vaccines specific to protect against
the pandemic
form of Asian bird flu."
Dr. Zinckgraf explained further that his colleagues at Antigen
Express
have discovered that a segment of the Ii immunoregulatory protein
acts on the
antigenic peptide presenting molecules in a manner that boosts the
presentation of T-helper cell epitopes to the immune system. Using
such a
vaccine in humans could augment the response to subsequent
vaccination by a
flu virus vaccine or as a stand-alone vaccine to prevent viral
infection.
The Antigen Express team is developing a vaccine for pandemic
Asian bird
flu (H5N1 strain) based on H5 MHC class II epitopes, which have been
selected
for likelihood of being both potent and presented by many HLA-DR
alleles.
Ii-Key/MHC class II epitope hybrid peptides contain an
immunoregulatory
segment of the Ii protein (the Ii-Key moiety), loosening the epitope-
binding
groove of MHC class II molecules and permitting insertion of a
polymethylene-linked MHC class II epitope. Doing so increases the
potency of
epitope presentation 200 times in vitro, as measured in a T-cell
hybridoma
response assay. In addition, Ii-Key hybrids with principal MHC
class II
epitopes of various cancer and infectious disease antigens increase
the
T-helper cell response 4-8 times in vaccinated mice, as measured
using
purified CD4+ T cell IFN-Y ELISPOT assays. Presently, Antigen
Express has an
ongoing phase I clinical trial with Her-2/neu breast cancer
hybrids. Data
from these trials are relevant to establishing the safety and effect
of this
novel type of vaccine, for later use in validating an influenza
vaccine.
Anna Gluskin, CEO of Generex Biotechnology said, "I am very
pleased with
the rapid advance of this vaccine program. Our earlier work on
developing a
vaccine for the SARS virus put us into a forward position with
design concepts
and animal models for infectious disease. Now we are shifting focus
toward
the Asian bird flu vaccine because that threat is potentially so
gigantic. We
feel that this T-helper cell peptide vaccine might be all that is
available,
in a rapid time frame, for people in many parts of the world. It is
also an
excellent priming vaccine, to be used before or with other vaccines
which are
being developed."

About Generex
Generex is engaged in the research and development of drug
delivery
systems and technologies. Generex has developed a proprietary
platform
technology for the delivery of drugs into the human body through the
oral
cavity (with no deposit in the lungs). The Company's proprietary
liquid
formulations allow drugs typically administered by injection to be
absorbed
into the body by the lining of the inner mouth using the Company's
proprietary
RapidMist(TM) device. The Company's flagship product, oral insulin
(Oral-lyn(TM)), which has been approved for commercial sale in
Ecuador for the
treatment of patients with Type-1 and Type-2 diabetes, is in various
stages of
clinical trials around the world. Antigen Express is a wholly owned
subsidiary of Generex. The core platform technologies of Antigen
Express
comprise immunotherapeutics for the treatment of malignant,
infectious,
allergic, and autoimmune diseases.

For more information, visit the Generex Web site at
www.generex.com .

Safe Harbor Statement: 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.

SOURCE Generex Biotechnology Corporation
Web Site: www.generex.com

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