Generex enrolls first prostate patients in Ph I cancer vaccine study

US firm Generex Biotechnology says that the first prostate cancer patients had been treated with its novel peptide vaccine in a Phase I clinical trial. The work is being conducted as an extension of a collaborative agreement between Generex' Antigen Express division and the Saint Savas Cancer Hospital. Greece. The Laikon Hospital, University of Athens, Greece, 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 levels will be monitored in patients throughout the study to assess tumor status.