WORCESTER, Mass. and TORONTO, Aug. 20, 2013 /PRNewswire/ -- Generex
Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced
publication of follow up studies from a Phase I clinical trial of its
immunotherapeutic agent AE37 in patients with prostate cancer. The Phase I study
demonstrated that the compound is safe, well-tolerated, and generated a specific
and robust immune response. AE37 is being developed by the Company's
wholly-owned subsidiary, Antigen Express Inc. (www.antigenexpress.com).
The report, entitled 'AE37 peptide vaccination in prostate cancer: a 4-year
immunological assessment update on a phase I trial' is being published in the
journal Cancer Immunology, Immunotherapy (August 2013). The journal focuses on
new concepts and advances in basic, translational, and clinical cancer
immunology and immunotherapy. Both the immunological and disease status of
patients was assessed as part of the follow up. Even three years after the last
dose of AE37 was administered, elevated levels of specific immunity could be
detected, demonstrating that the vaccine had indeed induced long-term
Intriguingly, none of the patients in this study belonging to the intermediate
or high risk groups as determined by Gleason score developed metastasis, even
though metastases would have been predicted to occur in roughly 27% of nine
intermediate-risk patients and 60% of eight high-risk patients based upon
historical data from patients with these stages of disease. In addition, the
median overall survival of six patients with metastatic disease was 89 months,
which considerably exceeds that usually observed in this group historically.
"While clearly not designed as an efficacy study, the lack of disease
progression observed in this Phase I trial is encouraging," commented Dr. Eric
von Hofe, Ph.D., President of Antigen Express. "The longevity of the
immunological response speaks to the robust yet specific mechanism of action of
AE37 and the technology platform upon which it was designed," he added.
AE37 is also the subject of a controlled, randomized and single-blinded Phase II
trial to prevent relapse in patients who have had breast cancer. An interim
analysis showed a strong trend toward reduction in relapse in patients receiving
the vaccine, particularly those with low to intermediate levels of the HER2
protein. Patients in this category have few treatment options. Primary efficacy
results from the study are expected to be released this fall. The FDA previously
has encouraged the company to submit a Phase III protocol based upon the interim
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(TM)
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 www.antigenexpress.com.
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