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Generex Provides an Overview of its Cancer Immunotherapy Product, AE37, and Potential in Early Breast Cancer Given Current and Potential Future Therapies
Date:1/30/2013

of the immune system that ensure generation of a robust and specific immune response. What makes this modification unique is that it amplifies the vaccine potency of the HER2 fragment without loosing specificity, unlike many non-specific immune stimulants. The Ii-Key modification can be added to many different 'payloads' to generate a specific and robust immune response. Given the increasing interest in cancer immunotherapy, this will be very attractive to companies wishing to 'supercharge' their specific vaccines.

The positive interim data of the AE37 trial have received particular attention given the robust and well-designed nature of the Phase IIb trial. In addition to being the only randomized, controlled and blinded study conducted with this type of HER2 targeted immunotherapy, it is also the largest vaccine therapy study conducted in the adjuvant breast cancer setting to date (330 patients). In recognition of the quality of the trial and encouraging results, the abstract reporting the interim results was recognized with a 2012 American Society of Clinical Oncology (ASCO) Merit Award bestowed by the Conquer Cancer Foundation and the 2012 Scientific Program Committee of ASCO. Further, the FDA has given the company the green light to proceed with submission of a Special Protocol Assessment for the Phase III trial.

Antigen Express is well positioned to execute on its business model, which includes potential out-licensing of additional clinical development of its lead compound in early breast cancer while pursuing additional products using its proprietary immunotherapy Ii-Key technology platform upon which AE37 is based. The advancement of AE37 in breast cancer clinical development will help to validate the company's immune technology platform. Low expression of the HER2 target is widespread among a variety of cancers including breast, prostate, ovarian, lung and cancers of the GI tract suggesting potential future areas for clinical research. Addit
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SOURCE Generex Biotechnology Corporation
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