Generex Biotechnology Corporation announced that its wholly owned subsidiary, Antigen Express, Inc., has received a Notice of Allowance in connection with US Patent Application No. 10/197,000 entitled Hybrid Peptides Modulate the Immune Response. The specific award covers fundamental aspects of the design and use of Ii-Key antigenic epitope hybrids in treating disease.

Potentiation of the therapeutic and prophylactic potency of vaccines using Ii-Key hybrids is a core component of Antigen Express technology. Ii-Key is a small fragment of the MHC class II associated invariant chain (Ii protein) that works by increasing the ability of specific antigens to stimulate T helper cells. Antigen Express has recently initiated a phase II clinical trial designed to test the efficacy of one of its immunotherapeutic Ii-Key hybrid vaccines (AE37) in breast cancer. It has also initiated clinical trials on a synthetic avian influenza vaccine designed using the same principal, a Generex press release stated.

"The allowances awarded offer broad protection for Ii-Key hybrid technology in the US," said Dr. Eric von Hofe, President of Antigen Express. "We are pleased to have this added level of protection." The company holds six awarded US patents covering the use of Ii technology for augmentation of vaccine potency.

Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs).