Generex Biotechnology Presents Potential Uses of RpaidmistR Technology in Transmucosal Vaccines at Merieux Conference in France

Company Expands Aerosolized Delivery Applications Beyond Insulin

TORONTO -- Generex Biotechnology Corporation (NASDAQ: GNBT), announced today (22 June 2004) the presentation of a research abstract by Robert Humphreys, the Chief Scientific Officer of its Antigen Express immunomedicines subsidiary, at the Foundation Merieux Conference, "Innate and Adaptive Immunity after Transcutaneous or Mucosal Vaccination." The conference was held in Annecy, France.

Dr. Humphreys presented: "Transmucosal Delivery of Therapeutics by RapidMistR Technology and TH-1 T-helper cell Ii-Key/MHC Class II Peptide Vaccines against Cancer and HIV."

Dr. Pankaj Modi, the Inventor of the technology at Generex, developed a novel method for aerosolized delivery of proteins and peptides through the buccal mucosa by a RapidMistR device using a pressurized fluorocarbon. 
The administering device, formulations and methods have been validated with insulin, for treatment of diabetes. The administered insulin is absorbed rapidly and provides a therapeutic plasma level within 20 minutes of application.

This device also enables needle-less, pain-free, repeated, low-dose administration of immunomodulatory peptides for the treatment of asthma and some autoimmune diseases. Control of such diseases might require frequent, low-dose administration of immunomodulatory peptides, which shut off pathological immune responses of the disease.

The potency of antigenic epitope-containing immunomodulatory peptides, is further enhanced by a second Antigen Express, Inc. technology, based on the Ii-Key peptide. The Ii-Key motif from the Ii protein acts at an allosteric site adjacent to the MHC class II antigenic peptide-binding trough to enhance presentation of covalently linked epitopes 200-500 times in vitro.

Such hybrid peptides can also be used as vaccine peptides for the therapy of cancer and infectious diseases. In vivo vaccination of mice with such Ii-Key/MHC class II epitope hybrids enhances immune responses to antigenic epitopes from cancer-related antigens for breast, colon, and ovarian carcinomas, melanoma and HIV.

The potency of other vaccine peptides is also greatly increased when linked to the Ii-Key active molecule. Antigen is pursuing programs for the use of such vaccines for HIV, SARS, and smallpox. Hybrids of the Ii-Key linked chemically to an antigenic epitope are potent vaccines in mouse models of human diseases.

Antigen Express has received 9 grants from the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the Department of Defense for the development of these compounds for many vaccine and treatment purposes.

"We are very pleased to project the use of our RapidMistR technology in the vaccine applications of Antigen Express," said Anna Gluskin, CEO of Generex said. "In cases where antigenic immunoregulatory peptides developed by Antigen Express must be administered twice a day, to control a disease process such as an acute flare in multiple sclerosis, only the needless RapidMistR method of administration will be accepted by patients and physicians."

About Generex
Generex is engaged in the research and development of drug delivery systems and technology. To date, it has focused on developing a platform technology for the buccal delivery -- delivery to the oral cavity for absorption through the inner mouth mucosa -- of drugs that historically have been administered only by injection. Generex's buccal delivery technology has application to a large number of drugs. Generex acquired Antigen Express in August. 2003. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.

This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755 or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc., +1-212-732-4300,
kensgro@ceocast.com , for Generex Biotechnology Corporation