First Prostate Cancer Patients Treated in A Phase I Clinical Trial

First Prostate Cancer Patients Treated in A Phase I Clinical Trial as Part of A Collaboration Between Generex Biotechnology and The Saint Savas Cancer Hospital

Generex Biotechnology Corporation (NasdaqCM:GNBT) announced today that the first prostate cancer patients had been treated with its novel peptide vaccine in a Phase I clinical trial. The trial is being conducted as an extension of a collaborative agreement between Generex's Antigen Express division and the Saint Savas Cancer Hospital. The Laikon Hospital, University of Athens will also function as a site for the trial.

In addition to safety, the Phase I study will seek to establish specific immunological responses to the AE37 vaccine peptide in 30 patients. AE37 consists of a peptide derived from the tumor associated HER-2/neu protein that has been modified to increase its ability to stimulate T helper cells. The same vaccine peptide has recently entered Phase II clinical trials in breast cancer patients, having been shown to be safe, well-tolerated and able to generate a specific immune response in a Phase I trial in breast cancer patients. Though the current study is not designed to test efficacy, imaging and Prostate Specific Antigen (PSA) levels will be monitored in patients throughout the study to assess tumor status.

Antigen Express has been collaborating with the laboratory of Dr. Costas Baxevanis of the Saint Savas Cancer Hospital for the past three years. Those studies have clearly shown the potential of AE37 both in stimulating T helper cells obtained from cancer patients as well as in pre-clinical animal tumor models.

Antigen Express is focused on developing active immunotherapy products for serious diseases and unmet medical needs. Currently the company has an immunotherapeutic peptide in Phase II clinical trials for breast cancer and in Phase I trials for the potentially pandemic H5N1 avian influenza.

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