Generex Provides Update on Antigen Express Phase II AE37 Breast Cancer Vaccine Trial

Generex Provides Update on Antigen Express Phase II AE37 Breast Cancer Vaccine

PR Newswire

WORCESTER, Mass. and TORONTO, Feb. 12, 2014

WORCESTER, Mass. and TORONTO, Feb. 12, 2014 /PRNewswire/ -- Generex
Biotechnology Corporation ( (GNBT) today announced that recent
results from a Phase II study of a novel cancer vaccine designed to prevent
relapse in patients who have had breast cancer corroborate prior results from
an interim analysis conducted in October of 2011. The Company plans to
disclose full results from the Phase II clinical trial at this year's American
Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from
May 30 to June 3, 2014. The ASCO Annual Meeting is the premier annual
oncology symposium, bringing together more than 25,000 oncology professionals
from a broad range of specialties. Two abstracts in respect of the results of
the Phase II trial have been submitted to the ASCO Annual Meeting; per ASCO
rules, the contents of those abstracts are embargoed pending the meeting.

The AE37 cancer vaccine is being developed by the Company's wholly-owned
subsidiary, Antigen Express, Inc. ( It is designed to
stimulate an immune response against the patient's cancer cells, preventing
relapse in patients who have been treated for early stage breast cancer.

The recent analysis is based on data from nearly 300 patients, making this the
largest controlled and randomized trial of a breast cancer vaccine trial
conducted to date. While full analysis of the recent results is still in
progress, the data corroborate qualitatively the data reported after an
interim analysis conducted two years ago. Specifically, the more prevalent
population of breast cancer patients ineligible to receive the drug Herceptin,
and particularly those in high-risk groups (e.g., triple negative breast
cancer), appear to benefit most from AE37. Both of these patient populations
represent areas of significant unmet need.

"We look forward to sharing details of the latest results from this
significant study with the medical community and the pharmaceuticals
industry," commented Mark Fletcher, Generex's President & Chief Executive
Officer. "We extend our thanks to the cancer patients and clinical
investigators who are participating in this important work."

The immunotherapeutic AE37 is designed to work indirectly by stimulating the
patient's immune system to recognize and kill cancer cells. An advantage of
the compound is that it potently activates a subclass of immune cells, known
at CD4+ T cells, without sacrificing tumor target specificity. This subclass
has been shown to be critical in generating a robust, long-lasting and
effective immune response. AE37 consists of a fragment of the
tumor-associated HER2 protein modified by a proprietary platform technology
developed by Antigen Express scientists.

The Company previously has been given the green light by the FDA to submit a
protocol for a Phase III study of AE37. In addition to breast cancer, the
Company has also completed a Phase I trial of AE37 in patients with prostate
cancer. Along with cancers of the breast and prostate, a variety of other
cancers such as ovarian, colon, and lung cancer similarly express some level
of HER2 and may be considered for future AE37 trials.

About Generex Biotechnology Corporation

Generex is engaged in the research, development, and commercialization 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
RapidMistâ„¢ device. Antigen Express, Inc. is a wholly owned subsidiary of
Generex. The core platform technologies of Antigen Express comprise
immunotherapeutic vaccines for the treatment of malignant, infectious,
allergic, and autoimmune diseases. Antigen Express has pioneered the use of
specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses
on modification of peptides with Ii-Key to increase potency, while a second
relies on inhibition of expression of the Ii protein. Antigen Express
scientists, and others, have shown clearly that suppression of expression of
the Ii protein in cancer cells allows for potent stimulation of T-helper cells
and prevents the further growth of cancer cells. For more information, visit
the Generex website at www.generex.comor the Antigen Express website at

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex
representatives in respect of 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," "plan," "believes," "will," "achieve,"
"anticipate," "would," "should," "subject to" 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 undertakes no
obligation to update publicly any forward-looking statements, whether as a
result of new information, future events or otherwise. 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
or ultimate regulatory approval cannot be regarded as actual predictions of
when Generex will obtain regulatory approval for any "phase" of clinical
trials or when it will obtain ultimate regulatory approval by a particular
regulatory agency. 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

Contact: Generex Contact: Generex Biotechnology Corporation, Todd Falls,
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