Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) today announced presentation of additional results from a recently completed Phase I clinical trial of its novel immunotherapeutic peptide AE37 in prostate cancer patients. AE37 is a synthetic cancer vaccine being developed by Antigen Express, Inc. (www.antigenexpress.com), a wholly owned subsidiary of Generex, for multiple cancer indications. The presentation was made at the 25th Anniversary Congress of the European Association of Urology (EAU) (www.uroweb.org), which was held in Barcelona, Spain from April 16 through April 20.
In addition to safety and the demonstration of a specific immunological response to AE37, it was shown that circulating levels of the extracellular domain of the HER2 protein were decreased in immunized patients compared to pre-vaccine levels. The AE37 vaccine was designed using a fragment of the HER2 protein and proprietary modifications developed at Antigen Express. The immunity generated by AE37 appeared to be long lasting, as significant vaccine-specific delayed type hypersensitivity (DTH) reactions were still apparent 6 months after the end of vaccinations. These results add to the body of data previously generated showing that AE37 is safe and immunologically active. Interim results from an ongoing Phase II trial of AE37 in breast cancer patients indicated that there were fewer recurrences in patients receiving AE37.
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