GNBT news,
That Schwab did not pick up till now:
Generex Biotechnology to Present Its Avian Influenza Vaccine Program at DNA Forum in London
Tuesday March 14, 8:30 am ET
TORONTO--(MARKET WIRE)--Mar 14, 2006 -- Generex Biotechnology Corporation (NasdaqSC:GNBT - News) announced today that Dr. Douglas Powell, Ph.D., Director of Immunobiology at Antigen Express, Inc., the Company's wholly owned immunotherapeutics subsidiary, will present the Antigen Express H5N1 avian influenza vaccine program at the upcoming Third Annual DNA Vaccines Forum to be held in London, UK, March 17 - 18, 2006.
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The strategy employed by Antigen Express focusing on the development of its novel H5N1 avian influenza vaccine utilizes small portions of the H5 protein that are modified to enhance antigen-specific stimulation of T-helper cells. Upon infection, such T-helper cell responses enhance the speed and strength of neutralizing antibody production. It is anticipated that the vaccine being developed will both impart some level of protection on its own and enhance the activity of other types of avian influenza vaccines, including DNA vaccines.
The meeting will focus on the latest advances involving DNA vaccine technology as well as clinical experiences and regulatory issues. All vaccines that are currently approved for human use are inactivated or attenuated (weakened) viruses or recombinant protein vaccines. DNA vaccines are a promising new approach with the potential to prevent many infectious diseases such as H5N1 influenza, anthrax and plague. Although a number of DNA vaccines are currently in clinical trials, none have been approved for use in humans. One of the challenges facing the use of DNA vaccines is that the responses generated in humans may be insufficient to prevent infection. To address this issue, scientists have investigated numerous methods to enhance the immunogenicity of DNA vaccines including the use of novel adjuvants and cytokines. For many diseases, including influenza, the generation of neutralizing antibodies produced by B lymphocytes is sufficient to protect against infection. The CD4 T cell response is essential for generating high levels of neutralizing antibodies in addition to eliciting memory T and B cell responses that provide protection against future infections. CD4 T cells recognize MHC class II epitopes presented on the surface of antigen presenting cells. Dr. Douglas Powell and Dr. John Zinckgraf at Antigen Express have demonstrated that immunization of mice with MHC class II epitopes derived from the H5N1 influenza hemagglutinin protein coupled to the proprietary Ii-Key peptide greatly enhances the CD4 T cell responses to a DNA vaccine encoding the H5N1 influenza hemagglutinin protein and may be used as a strategy to increase the immunogenicity of DNA vaccines.
One of the major challenges facing immunization with many of the currently available vaccines is the need for refrigeration, often referred to as maintenance of the cold chain. This is a particularly difficult problem in developing countries with limited medical resources. One of the advantages of a vaccine utilizing peptides and DNA is that both of these components can be lyophilized, stored at ambient temperatures and reconstituted "on-site" with saline. "We have promising data in an animal model suggesting that we will be able to achieve levels of immunity consistent with protection from H5N1," said Dr. Powell. The company has recently completed a pre-IND meeting with the FDA and hopes to enter human clinical trials of its peptide vaccine against H5N1 later this year.
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(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), 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 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:
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800) 391-6755 and (416) 364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212) 732-4300 |
