Generex Biotechnology Announces Positive Results of Clinical Studies on Novel Cancer Vaccine

Strategic Insights -

Generex Biotechnology Corporation, through its wholly owned immunotherapeutics subsidiary, Antigen Express, Inc., has announced positive results from clinical studies on a novel cancer vaccine, AE37, designed to elicit a specific response against the HER-2/neu oncogene. The Phase I clinical trial, conducted at the Walter Reed Army Medical Center in Washington, D.C., has shown that the vaccine is safe, well-tolerated, and produces a significant immune response in breast cancer patients. The results of the study will be presented at the 29th Annual San Antonio Breast Cancer Symposium.

Key Takeaways:

  • The Phase I clinical trial of AE37, conducted at the Walter Reed Army Medical Center, showed that the vaccine is safe and well-tolerated in breast cancer patients.
  • The trial produced a significant immune response in patients, with the vaccine eliciting a specific response against the HER-2/neu oncogene.
  • The results of the study have provided a solid foundation for subsequent Phase II studies and clinical trials on the use of AE37 in prostate cancer patients.
  • The AE37 vaccine relies on the ability of the immune system to recognize and target cancer cells, rather than directly interacting with the target protein, which is similar to the marketed cancer drug Herceptin.
  • The trial has shown that the immune system, once activated, is capable of detecting lower levels of the target protein than is Herceptin, and that the anti-tumor activity lasts long after termination of AE37 treatment.
  • Dr. Eric von Hofe, President of Antigen Express, stated that the Phase I studies have established the safety and optimal biological dose of AE37.

Statistics:

  • The clinical studies were initiated in April 2005 and were conducted at the Walter Reed Army Medical Center in Washington, D.C.
  • The trial included clinical data from the Phase I clinical trial of the Antigen Express cancer vaccine.
  • The AE37 vaccine is designed to elicit a specific response against the HER-2/neu oncogene, which is expressed in a high percentage of various types of cancer.

Sources:

  • Generex Biotechnology Corporation
  • Antigen Express, Inc.
  • The 29th Annual San Antonio Breast Cancer Symposium
  • Walter Reed Army Medical Center
  • Generex website at www.generex.com
  • Antigen Express website at www.antigenexpress.com