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Generex Announces Publication of Studies with the Mayo Clinic Confirming and Extending the Antigen Express Ii-Key Platform Technology
Date:7/11/2011

ulatory cell activation, known to have immune suppressive effects, adds to our prior findings and suggests Ii-Key hybrids could have potential in the field of cancer immunotherapy," he added.  Jos van der Woert, who has accepted the position of Chief Executive Officer of Antigen Express, commented:  "This study further supports the differentiating profile of AE37 with other cancer immunotherapies and provides additional momentum to AE37's clinical development."

Prior clinical studies of an Ii-Key hybrid peptide being developed by Antigen Express, AE37, including a Phase I trial in patients with prostate cancer and a separate trial in patients with breast cancer, have been reported as the subject of four publications in leading peer-reviewed journals.  In brief, those studies showed that AE37 is safe, well-tolerated, and produced immunological responses that were above-and-beyond what had been hoped for.  When compared with two other HER-2 vaccines that have been evaluated in the clinic, AE37 produced the greatest HER-2-related delayed-type hypersensitivity (DTH) reactions in immunized patients.  Of all immunological responses examined in patients undergoing active immunotherapy for cancer, it has been argued that a strong DTH response most reliably predicts efficacy.  In addition, it was found that AE37 was the only peptide able to generate an immunological response when administered without an adjuvant (co-stimulatory agent).  Finally, (as indicated above) AE37 also was the only peptide shown to decrease the level of T regulatory cells.

A controlled, randomized, and single-blinded Phase II clinical study of AE37 in HER-2 expressing breast cancer patients is currently underway to establish clinical efficacy.  The study endpoint is a reduction in cancer relapse after two years compared to the current standard of care treatment.  There are currently over 200 patients enrolled in the study with either node pos
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