Generex Biotechnology Corp. (fka GNBTQ)

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Conclusions: AE37 + GM-CSF is a novel vaccine that is safe and well tolerated with minimal toxicity. The primary analysis of this prospective, randomized, single-blinded phase II trial demonstrates benefit in patients with HER2 nOE tumors, especially those with triple negative tumors. These data justify a phase III trial evaluating AE37 administered in the adjuvant setting to a HER nOE or specifically TNBC population