Generex Announces Completion of Enrollment of Antigen Express Phase II AE37
Breast Cancer Vaccine Trial
WORCESTER, Mass. and TORONTO, Jan. 13, 2014
WORCESTER, Mass. and TORONTO, Jan. 13, 2014 /PRNewswire/ --Generex
Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced
completion of enrollment of the Antigen Express, Inc. (www.antigenexpress.com)
AE37 breast cancer immunotherapy trial. The clinical trial is designed to
assess the ability of AE37 to reduce the risk of relapse in patients who have
had breast cancer. While a pre-planned primary efficacy analysis is underway,
completion of enrollment sets the time-point for the end-of-trial analysis,
scheduled to be conducted one year's time.
"This represents a significant milestone for Generex and Antigen Express,"
said Mark Fletcher, President & Chief Executive Officer of Generex.
"Completion of enrollment of the Phase II, together with our primary efficacy
analysis, puts us in an ideal position to take advantage of the groundswell
resurgence of the promise of cancer immunotherapy." Representatives of both
Antigen Express and Generex are currently attending the J.P. Morgan Healthcare
Conference in San Francisco in response to enquiries from interested third
The Phase II trial has enrolled over 300 patients at 15 sites in the US and
Europe, making it the largest controlled, randomized, and single-blinded
world-wide breast cancer vaccine study conducted to date. Patients enrolled
in the trial have been previously diagnosed with node-positive or high-risk
node-negative breast cancer and have received standard of care therapy. They
were enrolled at the early stages of disease with the intent to establish the
ability of AE37 to reduce the incidence of relapse. An interim analysis
conducted on data obtained through October of 2011 showed a strong trend
suggesting that this was indeed the case.
AE37 is a synthetic, off-the-shelf therapeutic vaccine designed using a
fragment of the HER2 protein together with a proprietary modification
developed using the technology platform of Antigen Express. The modification
has been shown to activate CD4+ T helper cells, which are critical in the
development of an immune response, in a HER2-specific manner. In addition to
CD4+ T cell activation, immunological studies of treated patients show a
reduction of immune-suppressor cells, suggesting that the Antigen Express
modification may have multiple modes of action.
Based on results from the interim analysis conducted previously, the Company
was given a green light by the FDA to proceed with submission of a Phase III
protocol. That study has been designed to focus on patients with low levels
of expression of the HER2 protein who are not eligible to receive Herceptin.
This population of breast cancer patients is nearly double that which is
eligible for Herceptin treatment and thus represents an area of significant
unmet need and an untapped market segment.
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
RapidMist™ 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.com or 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 Biotechnology Corporation, Todd Falls, 800-391-6755
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