Generex says interim trial results show breast cancer drug safe

By Lisa Kerner

Erie, Pa., Jan. 25 - Generex Biotechnology Corp. released interim results of an ongoing clinical trial designed to assess the safety and immunological potency of a novel peptide vaccine (AE37) in patients with breast cancer.

The results demonstrate that AE37 is safe, well-tolerated and exhibits a dose-dependent immunologic response.

The therapeutic vaccine is being developed by its wholly owned subsidiary, Antigen Express, according to a company news release.

The compound, AE37, is a second-generation peptide vaccine designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene. Breast cancers as well as cancers of the lung, colon, stomach and pancreas express this oncogene, the company said.

A strong immune response against HER-2/neu offers the potential to kill tumor cells that have metastasized.

The trials, begun in April 2005, are being conducted at the Walter Reed Army Medical Center in collaboration with the Clinical Breast Care Project.

Clinical trials were begun to establish safety and immunological response to AE37. The trial will include up to 15 patients with stage 2 breast cancer. The patients include three receiving a low dose of peptide (100 micrograms), three receiving an intermediate dose (500 micrograms), and three receiving high dose (1,000 micrograms). The additional six will be treated at whichever of those doses induces the best immune response in the absence of toxicity.

A total of six doses of AE37 will be given at monthly intervals.

The initial 100 microgram dose group completed all six vaccines and all patients developed peptide-specific responses. The responses of patients in the 500 microgram group were apparent after only two doses.

Once this initial trial is completed, the company plans to conduct a pivotal trial looking at efficacy with a larger number of breast cancer patients.

Antigen Express is engaged in the development of immunotherapeutic vaccines that stimulate T helper cells.

"The demonstration of biological activity in the clinic is an important milestone for Antigen Express both in terms of product development and as validation for one of their platform technologies," Anna Gluskin, Generex president and chief executive officer, said in the release.

"We look forward to further results from these trials and in advancing additional immunotherapeutics based on this technology for oncology and in the area of infectious disease."

Toronto-based Generex is engaged in the research and development of drug delivery systems and technologies.

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