Generex Biotechnology Corporation announced that Antigen Express, Inc, the company's wholly-owned immunotherapeutics subsidiary, and the Immune Tolerance Network have signed an agreement aimed at implementing a better diagnostic test for type-I diabetes. The diagnostic test is based on technology being developed by Antigen Express. The ability to identify patients with autoimmune or type-I diabetes earlier and more accurately would greatly benefit the management of such patients.

The proprietary technology being developed at Antigen Express allows for more potent and specific activation of immune cells (CD4+ T helper cells), both after immunization and using blood cells ex vivo. In type-I diabetes, these cells become aberrantly activated to recognize proteins associated with cells involved in insulin secretion, which ultimately leads to the destruction of these cells. Antigen Express technology allows for the more sensitive detection of these inappropriately activated cells in the blood.

The Immune Tolerance Network is a non-profit, government-funded consortium led by the world's foremost authorities in the field of immune tolerance. The group is focused on establishing new treatments for autoimmune diseases (eg type-I diabetes, multiple sclerosis, and others), organ transplant rejection, and on the prevention and treatment of allergies and asthma.

Antigen Express is also developing an immunotherapeutic vaccine for breast, prostate and other cancers. The technology utilized in the design of that immunotherapeutic is the same as that used for the ex vivo detection of inappropriately activated CD4+ T helper cells in patients with type-I diabetes. To date, the anti-cancer immunotherapeutic being developed, AE37, has been shown to be safe, well tolerated and produces the desired specific immune response in cancer patients. Currently, AE37 is the subject of a phase-II efficacy study in patients with breast cancer, a phase-I study in patients with prostate cancer and, in combination with another peptide vaccine, a phase-I trial in patients with either breast or ovarian cancer. A synthetic peptide vaccine for H5N1 avian influenza, based on the same technology, is also the subject of a phase-I trial in healthy volunteers.

Generex is engaged in the research, development and commercialization of drug delivery systems and technologies.