Generex Data Presented At American Association for Cancer Research 100th Annual Meeting

Generex Biotechnology Corporation announced today that Antigen Express, Inc., its wholly-owned immunotherapeutics subsidiary, has presented recent pre-clinical findings on a novel immunotherapeutic vaccine for human papilloma virus (HPV)-induced cancers

WORCESTER, MA, USA | April 20, 2009 | Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) announced today that Antigen Express, Inc., its wholly-owned immunotherapeutics subsidiary, has presented recent pre-clinical findings on a novel immunotherapeutic vaccine for human papilloma virus (HPV)-induced cancers. The study, entitled: "Ii-Key/HPV16 E7 hybrid peptide vaccine for HPV16+ cancers," was presented by Dr. Minzhen Xu, Ph.D., the Antigen Express Vice-President of Biology, at the 100th Annual Meeting of the American Association for Cancer Research (www.aacr.org) in Denver, CO, being held from April 18-22, 2009.

The AACR 100th Annual Meeting 2009, with the theme of "Science, Synergy, and Success," highlights the best cancer science and medicine from institutions all over the world.

The Antigen Express study reports on the identification of a modified peptide vaccine with the potential to treat patients with HPV induced cancers. In particular, a fragment of the HPV16 E7 protein, which is involved in the tumorigenic activity of the virus, was modified by proprietary Antigen Express technology to enhance stimulation of CD4+ T helper cells. The modified vaccine peptide was roughly 5-fold more potent than the unmodified peptide in the generation of antigen-specific T helper cells in a pre-clinical mouse model. Furthermore, the increase in antigen specific T helper cells were associated with significantly increased killing of HPV antigen-presenting target cells.

Antigen-specific stimulation of T helper cells is critical in the generation of an effective anti-tumor response. While vaccines have been developed that are effective at preventing infection by HPV, no current vaccine is of benefit in patients with cervical or other cancers induced by HPV. In addition, the availability of a synthetic peptide vaccine may be helpful in promoting the more widespread use of a prophylactic HPV vaccine, which has been hindered by the cost of the existing vaccine.

Antigen Express is currently conducting a randomized Phase II trial of a similarly modified fragment of the HER2 protein (AE37) in breast cancer patients, a Phase I trial in prostate cancer patients, and another Phase I trial in breast or ovarian cancer patients wherein AE37 is combined with another peptide vaccine. In the studies performed to date, the immunotherapeutic vaccine has been found to be safe, well tolerated, and produces the desired immunological response. A Phase I trial of a synthetic peptide vaccine for H5N1 avian influenza is also underway.

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization 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). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831

SOURCE: Generex Biotechnology Corporation

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