Generex to Increase Patient Enrollment of its Phase II Breast Cancer Vaccine Study

WORCESTER, Mass., Jan. 25, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTC Bulletin Board:GNBT), together with its wholly-owned immunotherapeutic vaccines subsidiary, Antigen Express, Inc. (www.antigenexpress.com), announced today that it has amended the Clinical Study Agreement with The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (www.hjf.org) in regard to the on-going Phase II clinical study of Antigen's AE37 novel immunotherapeutic vaccine for the treatment of breast cancer.

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The purpose of the amendment is to augment the study by increasing the number of patients enrolled in the study (from 190 to 330) and to amend the study protocol by modifying the inclusion criteria applicable to new enrollees to ensure good representation of patient populations being considered for the upcoming Phase III trial.  Antigen Express has engaged Inclinix, Inc. (www.inclinix.com) to provide patient recruitment services to expedite the enrollment of the additional patients.  Inclinix specializes in customized Phase I-IV clinical trial enrollment solutions for global pharmaceutical, biotechnology, and medical device organizations.  

Additionally, in an effort to ascertain the value of the AE37 breast cancer vaccine at its current stage of development, management engaged a leading national independent valuation firm specializing in pharmaceuticals to prepare an appraisal for Generex as it moves into the later stages of clinical trials and implements a strategic plan for AE37 including the evaluation of potential commercialization collaborations.  The report defined fair value as the price at which an asset or liability could be exchanged in a current transaction between knowledgeable, unrelated willing parties, and arrived at a value of $300 million. Willing parties are presumed to be marketplace participants representing unrelated buyers and sellers.  Given that Herceptin, which is only available to treat roughly one-third of the patients that would be eligible for AE37, had sales of $1.8 Billion in 2008, the Company believes this estimate to be conservative.  The report did not include or evaluate the potential use of AE37 for treatment of other cancers expressing lower levels of HER2 than are required for use with Herceptin, such as prostate, ovarian, colon, and lung tumors.  Antigen Express recently completed a Phase I study of the AE37 vaccine for prostate cancer and a Phase I study of the AE37 vaccine for ovarian cancer is underway.

Commenting on the AE37 developments, Dr. Eric von Hofe, Ph.D., President of Antigen Express, stated: "We look forward to advancing our Phase II study with these modifications and are excited to have received an independent appraisal demonstrating the current value of this vaccine for breast cancer treatment.  We are confident that our data will provide convincing evidence of the far reaching value of this potentially life saving vaccine."  Dr. von Hofe went on to add: "Given that this low HER2 expression patient population has very limited options and is uniquely eligible for AE37 therapy, it is important to ensure that they are well represented in our ongoing Phase II trial.  The fact that these low HER2 expressing patients can be treated with AE37," continued Dr. von Hofe, "doubles or triples the number of breast cancer patients eligible for AE37 relative to Herceptin."

AE37 represents a new class of self-potentiating peptide vaccines designed to stimulate the immune system to specifically recognize and kill cancer cells.  Antigen Express has previously announced interim data from the study indicating fewer relapses in the AE37 arm of the study versus the placebo controlled arm.  The Company anticipates that a Phase III clinical study of the breast cancer vaccine will be initiated prior to the completion of the extant Phase II study.  Results from the ongoing Phase II study would be used for patient number adjustment, thereby assuring statistical significance in the Phase III registration trial.

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.  The Company's buccal insulin spray product, Generex Oral-lyn™ is in Phase III clinical trials at several sites around the world.  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 in immunotherapy.  One of its platform technologies 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.

Safe Harbor Statement

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," "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 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