SOURCE: Generex Biotechnology

March 19, 2007 07:15 ET

Generex Scientist to Present on the Status of Influenza Vaccine Development at National Conference

TORONTO -- (MARKET WIRE) -- March 19, 2007 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that Dr. Douglas Powell, Ph.D., Director of Immunobiology at Antigen Express, Inc., the Company's wholly owned immunotherapeutics subsidiary, will make a presentation at the World Vaccine Congress 2007 to be held in Washington, D.C., March 19th and 20th. The Company recently began treating volunteers in a clinical trial of the first synthetic avian influenza vaccine to be tested in humans.

Dr. Powell will present "Influenza Vaccines: What Do We Have Today?" at the 7th World Vaccine Congress on Tuesday, March 20th at the Four Seasons Hotel in Washington, D.C. The conference will cover key aspects of current vaccine development efforts, ranging from novel technologies, manufacturing, regulatory, and business issues.

Dr. Powell's talk will summarize the results of H5N1 vaccines currently under development. Influenza vaccines have been produced in embryonated chicken eggs for the past 50 years to meet the needs for vaccines designed to protect individuals against seasonal flu. While the H5N1 virus can be produced in this way, yields are far lower than for seasonal flu strains and the amount of H5N1 vaccine needed to elicit a protective response to the virus is far greater than the amount found in seasonal flu vaccines. The worldwide capacity for production of H5N1 in chicken eggs is estimated to be about 13 kilograms, which is enough for approximately 70 million doses. The H5N1 virus is present in wild and domestic bird populations and has been detected in most countries in the world. Although at present it does not appear to be easily transmissible from birds to people or from one person to another, if mutations occur making the virus transmissible like seasonal influenza viruses an H5N1 pandemic is highly likely. Unlike seasonal influenza, which usually causes a mild disease, infection with H5N1 virus is fatal in 50% of human cases. It is unlikely that the traditional methods for producing influenza virus vaccines will be sufficient to prepare the world's population against the threat of an H5N1 pandemic. This is why there is an urgent need to develop novel vaccines for H5N1. For these reasons the Company as begun development of novel H5N1 vaccines that are composed of synthetic peptides, recombinant protein and/or DNA vaccines. The advantages of these synthetic peptides, recombinant protein and DNA vaccines are that they can be mass produced in sufficient quantities with currently available technologies to prepare for a potential pandemic with H5N1.

Antigen Express recently initiated the first human clinical studies of its proprietary synthetic bird flu vaccine. To date, only egg-based or cell culture-based vaccines have been studied for their ability to confer protection against the potentially pandemic H5N1 bird flu. The synthetic vaccine can be made much more rapidly and cost effectively relative to other vaccines, offering the possibility of far greater population coverage.

Dr. Powell will appear in an interview on Bloomberg television Monday evening, March 19 at 6 p.m. to discuss the subject of his talk.

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
    CEOcast, Inc.
    212-732-4300