The completed Phase I trial was a dose escalation study to establish the safety and immunologic activity of AE37 in 15 node-negative breast cancer patients. The patients received six immunizations at monthly intervals of 100, 500 or 1000mcg of AE37 combined with 0 to 250mcg of GM-CSF as adjuvant.
Because of a robust local response in patients receiving 500mcg of AE37, patients were dosed with 1000mcg of AE37 in the absence of adjuvant. Even in the absence of adjuvant, two of the three patients receiving 1000mcg of AE37 required a reduction in the amount of AE37 because of a robust local response, indicating the inherent potency of AE37. Analysis of T cells taken from patients as well as delayed-type hypersensitivity tests demonstrated that there was a significant and specific immune response in patients receiving AE37.
The AE37 vaccine is derived from a fragment of the HER-2/neu oncogene, which is over-expressed in a variety of tumors, including breast, ovarian, prostate, colon and lung tumors.
Anna Gluskin, president and CEO of Generex, said: “The results of this trial offer proof of our progress in successfully bringing AE37 through the clinical regulatory process. This trial represents the first human experience with the Ii-Key modification, and to our knowledge AE37 is the first peptide-based cancer vaccine to show potency in the absence of an immunoadjuvant.”