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Published on 11/6/2006 in the Prospect News Biotech Daily.

Generex begins phase 1 trials of synthetic avian flu vaccine

By Jennifer Lanning Drey

Portland, Ore., Nov. 6 - Generex Biotechnology Corp. has begun phase 1 clinical trials of its Antigen Express synthetic avian influenza vaccine under an agreement with the Lebanese-Canadian Hospital in Beirut, Eric von Hofe, president of Antigen Express, told investors Monday at the Rodman & Renshaw 8th Annual Healthcare Conference.

Generex expects to begin dosing patients in the study by the end of November, von Hofe said.

The vaccine was created using the proprietary platform of immune modulation technologies that is also being used by Generex's wholly owned subsidiary, Antigen, to develop vaccine products for indications including breast cancer, prostate cancer and HIV.

The influenza vaccine is based on peptide-synthesis technology and because it is synthetic can be manufactured quickly and cost effectively at facilities around the world, von Hofe said.

The company also is concluding phase 1 clinical trials of a breast cancer vaccine based on the same technology and expects to begin phase 2 clinical trials within six months, he said.

The phase 1 breast cancer trials demonstrated that the Antigen vaccine has a good immunological effect and was well-tolerated and safe. The phase 2 trial will study efficacy, von Hofe said.

The company also is preparing to begin a phase 1 study of a similar prostate cancer vaccine and plans to take its melanoma vaccine into the clinic within the next year, he said.

Additionally, the Antigen Express technology is being used to develop an intratumoral genetic vaccine and an immuno-diabetics program that has identified peptides that can be used to identify diabetics in a pre-diabetic state, he said.

The company is also studying peptide and DNA vaccines for HIV.

In addition to the Antigen Express technology platform, Generex has a diabetes franchise that is developing alternate delivery methods to injectable insulin for diabetes patients, including inhaled and oral insulin as well as a Metformin Gum.

Toronto-based Generex develops drug-delivery systems and technologies.


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