SOURCE: Generex Biotechnology

May 02, 2007 08:00 ET

Generex Biotechnology Announces Treatment of First Breast Cancer Patients in Phase II Clinical Trial

Trial of Second Generation Immunotherapeutic Vaccine Being Conducted With U.S. Military Cancer Institute's Clinical Trials Group

WORCESTER, MA -- (MARKET WIRE) -- May 2, 2007 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that the first patients have been treated in a Phase II clinical trial of its novel immunotherapeutic vaccine AE37 being developed by Generex's wholly owned Antigen Express subsidiary. The trial is being conducted with the United States Military Cancer Institute's (USMCI) Clinical Trials Group pursuant to a Clinical Trial Agreement under the direction of COL George Peoples, M.D. The endpoint for this study is the rate of relapse in patients with node-positive or high-risk node-negative breast cancer after two years.

The study is randomized and will compare patients treated with AE37 plus the adjuvant GM-CSF versus GM-CSF alone. The goal is to demonstrate at least a 50% reduction in the rate of relapse in patients treated with AE37. The Phase II trial follows a Phase I trial (begun in April 2005) that demonstrated safety, tolerability, and immune stimulation of the AE37 vaccine in breast cancer patients.

The immunotherapeutic vaccine being developed by Antigen Express represents a second generation peptide vaccine for cancer immunotherapy. AE37 was designed using a fragment of the HER-2/neu oncoprotein modified by proprietary means to enhance its ability to activate T helper cells for recognition of HER-2/neu. The advantages of this type of active immunotherapy are both safety and the ability to have activated immune cells patrolling for cancer cells long after the therapeutic has been given.

In addition to the current Phase II breast cancer trial, AE37 is also being investigated in a Phase I trial in patients with HER-2/neu-expressing prostate cancer. Antigen Express has also developed a prophylactic vaccine for the potentially pandemic H5N1 avian influenza virus that is currently in Phase I clinical trials; that vaccine was designed using the same technology platform as that used for AE37.

"We are excited to be entering this new phase of clinical testing for efficacy after a Phase I trial that demonstrated strong immunotherapeutic results," said Anna Gluskin, President & Chief Executive Officer of Generex Biotechnology. "Given the limitations of traditional chemotherapy, active immunotherapy represents a promising new modality for the treatment of cancer."

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 (Generex Oral-lyn™), which is available for 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 website at www.generex.com or the Antigen Express website at www.antigenexpress.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

  • For more information, please contact:

    For Generex:
    Shayne Gilliatt of Generex
    800-391-6755 or 416-364-2551

    Andrew Hellman of CEOcast, Inc.
    212-732-4300