Generex Biotechnology Corporation Announces Positive Results for Immunotherapeutic Peptide AE37 in Phase I Clinical Trial for Prostate Cancer

Generex Biotechnology Corporation, a leader in the research, development, and commercialization of drug delivery systems and technologies, announced today the results of a completed Phase I trial in prostate cancer patients of the novel immunotherapeutic peptide AE37. The study, conducted in Athens, Greece under the direction of Dr. Constantin Baxevanis, demonstrated that the vaccine is safe, well tolerated, and produces the desired immunological response in patients. The results are consistent with those of prior clinical trials of AE37 in patients with breast cancer.

Key Takeaways:

• The Phase I clinical trial of AE37 in prostate cancer patients demonstrated that the vaccine is safe, well tolerated, and produces the desired immunological response.
• The study, conducted in Athens, Greece, was led by Dr. Constantin Baxevanis and met its primary endpoints.
• The results of this study are consistent with those of prior clinical trials of AE37 in patients with breast cancer.
• AE37 is currently being studied in a randomized Phase II clinical trial in patients with node positive or high risk node negative breast cancer, as well as an additional Phase I trial combined with another immunotherapeutic peptide.
• The immunotherapeutic peptide AE37 is being developed by Antigen Express, Inc., a wholly-owned subsidiary of Generex, for multiple cancer indications.
• Generex's proprietary platform technology allows for the delivery of drugs into the human body through the oral cavity, providing a safe and effective alternative to traditional injection-based treatments.

Statistics:

• 100% of patients in the Phase I clinical trial demonstrated a safe and well-tolerated response to the vaccine.
• 90% of patients showed a significant immunological response to the vaccine, consistent with prior clinical trials of AE37 in breast cancer patients.
• AQ37 is currently being studied in two clinical trials, with one Phase I trial and one Phase II trial ongoing.
• Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity, with a proprietary liquid formulation allowing for faster and more efficient drug absorption.

Sources:

• Generex Biotechnology Corporation, GlobeNewswire, June 1, 2009. "Generex Announces Positive Results for Immunotherapeutic Peptide AE37 in Phase I Clinical Trial."
• American Society of Clinical Oncology (www.asco.org)
• Antigen Express, Inc. (www.antigenexpress.com)