Generex begins testing new vaccine for breast cancer patients

Generex Biotechnology Corporation announced today that the first patients had received a novel therapeutic vaccine developed by its wholly owned subsidiary, Antigen Express as part of the Company's Phase I Trial. The Trial will include between 16 and 24 patients.

The compound, AE37, is designed to stimulate an immune response against the tumor-causing gene HER-2/neu, which occurs in a significant percentage of patients with breast cancer as well as other cancers. A robust immune response against HER-2/neu has the potential to destroy tumor cells even at sites in the body distant from the primary tumor.

There are two main distinguishing features of the current trial. The first is that it focuses on developing a specific immune response against a target critical to the growth of tumor cells (HER-2/neu) rather than simply providing non-specific immune stimulation. This is much less likely to produce undesirable side effects than non-specific forms of immunotherapy.

Secondly, AE37 works through a portion of the immune system, represented by the T helper cells, that has been largely overlooked up to now in developing cancer immunotherapy strategies. In recent years, both pre-clinical and clinical studies have shown that stimulation of helper T cells is crucial for generating a robust, long-lasting and effective immune response.

The compound being examined, AE37, is composed of a small piece of the HER-2/neu protein coupled to a portion of the MHC class II-associated invariant chain (Ii protein) shown to greatly enhance stimulation of T helper cells. The discoveries that led to AE37 are based on the work of Dr. Robert Humphreys, founder of Antigen Express, who was first to identify both MHC class II molecules and their role in stimulating T helper cells as well as a portion of the Ii protein capable of dramatically increasing the response of T helper cells to specific antigenic epitopes.

In addition to establishing the safety of AE37, the current trial will establish both the level and longevity of specific T cell stimulation induced by AE37.

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