The International Journal of Cancer Publishes Studies on Generex Biotechnology's Anti-cancer Activity of Its Immunotherapeutic Vaccine
WORCESTER, MA - July 31, 2007 - Generex Biotechnology Corporation (NasdaqCM:GNBT) announced today publication in the peer-reviewed International Journal of Cancer (published online 16 Jul 2007) of studies demonstrating the anti-tumor activity of its novel Ii-Key/HER-2/neu immunotherapeutic vaccine as well as mechanistic explanations for the enhancements observed using this proprietary vaccine. The studies were conducted as part of a collaboration between the Cancer Immunology and Immunotherapy Center, Saint Savas Cancer Hospital, Athens, Greece and Antigen Express, Inc., the immunotherapeutic subsidiary of Generex. The article was authored by Ioannis F. Voutsas, Angelos D. Gritzapis, Louisa G. Mahaira, Maria Salagianni, Eric von Hofe, Nikoletta L. Kallinteris, and Constantin N. Baxevanis.
The International Journal of Cancer publishes material under a
broad scope of topics relevant to experimental and clinical cancer
research. Its readership is comprised of cancer physicians and
investigators, epidemiologists, virologists, immunologists,
oncologists, and occupational and environmental health
scientists.
The publication, entitled "Induction of potent CD4+ cell-mediated responses by a helper HER-2/neu peptide linked to the Ii-Key moiety of the invariant chain", presents studies showing how the proprietary portion of the immunotherapeutic vaccine enhances the potency of peptide vaccines. Specifically, the modification developed by Antigen Express increases the interaction time between the peptide vaccine and T helper cells, thereby enhancing specific stimulation against the HER-2/neu peptide. The further studies show that T helper cells stimulated by the vaccine increase the length of time tumor-infiltrating lymphocytes exhibit anti-tumor activity.
The HER-2/neu vaccine being developed by Antigen Express (AE37) is
currently in Phase II clinical trials in patients with breast
cancer. Those studies are being conducted in conjunction with
United States Military Cancer Institute's Clinical Trials Group
under a Clinical Trial Agreement. The same compound will also be
investigated in patients with HER-2/neu-positive prostate cancer.
Patients for those trials have been selected and dosing is expected
to begin before the fall of 2007. The latter trial will be
conducted as an extension of the collaboration between Antigen
Express and the Saint Savas Cancer Hospital.
"Our recent studies further establish the scientific underpinnings
of the Antigen Express technology in general and for the clinical
development of AE37 in particular," said Dr. Eric von Hofe,
President of Antigen Express. "Publication in the International
Journal of Cancer demonstrates the thoroughness and scientific
rigor that goes into the development of Antigen Express
products."
In addition to the development of immunotherapeutic cancer
vaccines, Antigen Express is also developing vaccines for
infectious diseases. A Phase I trial of a peptide vaccine for use
against the potentially pandemic H5N1 avian influenza virus,
developed using the same technology used for AE37, was recently
initiated. The particular advantage of Antigen Express vaccine
technology for preparation against bird flu is that it relies on
the use of synthetic peptides, which can be manufactured more
rapidly and in larger amounts than traditional vaccines.
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
RapidMistT device. The Company's flagship product, oral insulin
(Generex Oral-lynT), which is available for sale in Ecuador for the
treatment of patients with Type-1 and Type-2 diabetes and before
the end of 2007 the Company expects to begin Phase 3 trials of the
product in the United States, Canada and Europe. 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 website at
www.generex.com or the Antigen
Express website at www.antigenexpress.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 cannot be sure when or
if it will be permitted by regulatory agencies to undertake
additional clinical trials or to commence any particular phase of
clinical trials. Because of this, statements regarding the expected
timing of clinical trials cannot be regarded as actual predictions
of when Generex will obtain regulatory approval for any "phase" of
clinical trials. Generex claims the protection of the safe harbor
for forward-looking statements that is contained in the Private
Securities Litigation Reform Act.
# # #
For more information, please contact:
For Generex:
Craig Kulman
American Capital Ventures, Inc.
305-918-7000
Andrew Hellman
CEOcast, Inc.
212-732-4300
Posted: July 2007
