SOURCE: Generex Biotechnology

January 25, 2006 08:00 ET

Generex Biotechnology Announces Interim Results of Clinical Breast Cancer Trials

Collaboration With Walter Reed Army Medical Center Demonstrates Good Response to Novel Peptide Vaccine

TORONTO -- (MARKET WIRE) -- January 25, 2006 --Generex Biotechnology Corporation (NASDAQ: GNBT) announced today interim results of an ongoing clinical trial designed to assess the safety and immunological potency of a novel peptide vaccine in patients with breast cancer. The therapeutic vaccine is being developed by its wholly owned subsidiary, Antigen Express.

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. A significant percentage of breast cancers as well as cancers of the lung, colon, stomach and pancreas express this oncogene. A strong immune response against HER-2/neu offers the potential to kill tumor cells that have spread to parts of the body distant from the primary tumor.

The trials are being conducted at the Walter Reed Army Medical Center (WRAMC) in collaboration with the Clinical Breast Care Project (CBCP). The CBCP is a Congressionally-mandated civilian-military collaboration between WRAMC, the Windber Research Institute (Windber, PA), and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. The mission of the CBCP is to undertake advanced research in breast cancer prevention, diagnosis, and treatment.

Clinical trials were initiated in April of 2005 to establish safety and immunological response to AE37. The trial will include up to 15 patients with stage II breast cancer when completed, including three patients treated at a low dose of peptide (100 micrograms), three at an intermediate dose (500 micrograms), three at a high dose (1000 micrograms) and an additional six at whichever of those doses induces the best immune response in the absence of toxicity. Each dose group will receive six doses of AE37 at monthly intervals. The initial 100 microgram dose group has completed all six vaccinations and all patients developed peptide-specific responses to the immunizing peptide. The response of patients was measured by reactivity of their T cells to AE37 as measured both by their ability to proliferate after being exposed to the peptide and to secrete cytokines. While the proliferation assay showed consistent responses among the patients, the cytokine responses were more variable, with one low responder, one intermediate and one high responder. The responses of patients in the 500 microgram group have come much sooner than was seen in the 100 microgram group. After only two inoculations, the proliferative responses of patients' T cells were 2.7 to 5.7 times the highest levels observed in patients receiving 100 micrograms. In addition, cytokine responses in patients receiving two inoculations in the 500 microgram group were already greater than the highest response observed in any patient of the 100 microgram group. In short, AE37 appears to be safe, well-tolerated and exhibits a dose-dependent immunologic response. Once this initial trial is completed, it is planned 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. This is accomplished by coupling a small portion of the MHC class II-associated invariant chain (Ii Protein) to a known MHC class II antigenic epitope. The discovery that the resulting 'hybrid' peptide is much more potent than the antigenic epitope alone in stimulating T helper cells forms the basis of a proprietary technology platform at Antigen Express. Hybrid vaccine peptides for the potentially pandemic H5N1 avian influenza virus as well as for HIV using the same platform are also under development.

"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," said Anna Gluskin, President & Chief Executive Officer of Generex. "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."

About Generex

Generex is engaged in the research and development 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™ device. The Company's flagship product, oral insulin (Oral-lyn™), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express 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 Web site at www.generex.com.

Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Contact Information

  • Contact:
    ShayneGilliatt
    Generex Biotechnology Corporation
    Phone: (800)391-6755
    and (416)364-2551

    Ed Lewis
    CEOcast, Inc.
    Phone: 1 (212)732-4300