AE37 Cancer Vaccine
 

Generex Announces ASCO Presentations on the Antigen Express Advanced Stage AE37 Cancer Vaccine
Studies show superiority of AE37 among peptide cancer vaccines

WORCESTER, Mass. and TORONTO, May 22, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced three presentations demonstrating the superiority of the AE37 breast cancer vaccine being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The presentations will be made at the annual meeting of the American Society of Clinical Oncology (ASCO) to be held in Chicago from May 31 through June 4, 2013.
The presentation entitled "Booster inoculations of the AE37 peptide vaccine enhance immunological responses in a phase II study", by Eleftheria Anastasopoulou et al, demonstrates that increased immunological responses observed after the initial series of inoculations with AE37 can be further increased over a 24 month period in patients receiving boosters every six months. The AE37 vaccine is a combination of a fragment of the HER2 protein plus a proprietary modification developed by Antigen Express scientists.
The presentation entitled "Risk factors for development of delayed urticarial reactions in the phase II trial of HER2 peptide vaccines plus GM-CSF versus GM-CSF alone in high-risk breast cancer patients to prevent recurrence", by Alfred Trappey et al, demonstrates that the only side effects are associated with the GM-CSF adjuvant rather than the AE37 peptide and are entirely manageable.
A third online abstract entitled "Effect of immunization with Ii-Key modified HER2 (776-790) peptide vaccine (AE37) on immunologic responses in prostate cancer patients", by Sonia Perez et al, demonstrates long-term immunological response to AE37 in prostate cancer patients in the absence of booster administration. Two measures of an elevated, specific immune response were statistically unchanged even three years after the initial treatment regimen. This period is longer than reported for any prior peptide vaccine.
Taken together, these three studies demonstrate that AE37 is meeting or exceeding all expectations for generating a specific, robust and long-lived immune response while maintaining a favorable safety profile. Interim results from the controlled, randomized and single-blinded Phase II trial in patients who have had breast cancer show a strong trend toward decreased relapse in patients who have received the vaccine.
The primary efficacy analysis of Phase II data from the breast cancer study is expected prior to the end of 2013. Mark Fletcher, Generex President & Chief Executive Officer, commented: "Based on the outstanding interim results announced at ASCO 2012, we are looking forward to qualitatively similar results with greater statistical robustness when data are evaluated later this year, which will leave Antigen Express well-positioned to secure a partnership for a Phase III trial." Antigen Express has been encouraged by the US Food and Drug Administration to submit a protocol for the Phase III trial, which the Company is in the process of preparing under the auspices of a Special Protocol Assessment (SPA), whereby the FDA declares the design, clinical endpoints, and statistical analyses acceptable for FDA approval.

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(END) Dow Jones Newswires
May 22, 2013 09:00 ET (13:00 GMT)