3/3/2008 Generex Biotechnology Extends Clinical Trial Agreement for Testing its Synthetic Avian Influenza Vaccine
Worcester, Mass., March 3, 2008 - Generex Biotechnology Corporation (NasdaqCM:GNBT) announced today that it has extended its agreement with the Lebanese-Canadian Hospital in Beirut for follow-on testing of specific peptides screened over the past year. During the initial screening, it was found that all vaccine peptides were safe and well tolerated. The vaccine is being developed both in the US and at the Lebanese-Canadian Hospital in Beirut. Dr. Alexander Abdelnoor, an immunologist at the American University of Beirut, is also participating as a consultant for the trials.
The vaccine is being developed using the technology platform established by Antigen Express, a wholly-owned subsidiary of Generex. The vaccine consists of small peptide fragments of the H5 protein from the H5N1 influenza virus that have been modified to increase the ability to specifically stimulate CD4+ T helper cells. Activation of these cells has been shown to be critical in generating and maintaining an immune response against pathogenic agents. This is particularly important in the case of the potentially pandemic H5N1 influenza virus, as most people have had no prior exposure to it. Current egg- or cell culture-based vaccines need to be administered in two relatively large doses to establish immunity. This observation, combined with the limitations on egg- and cell culture-based manufacturing, has made it clear these types of vaccines will not be in adequate supply in the event of an H5N1 outbreak. The vaccine being developed by Antigen Express, in contrast, is produced by synthetic methods and thus can be made rapidly and inexpensively. This synthetic vaccine is expected to augment the activity, and thus the number of people, that could be immunized with a more traditional vaccine as well as to protect against the lethality of the H5N1 virus when used alone.
To date, over 100 volunteers have received the Antigen Express vaccine peptides, which appear to be safe and well tolerated. No serious side effects due to the vaccine have been observed. In addition to safety, immunological responses to the vaccine have been monitored. Based on this monitoring, repeat immunizations using some of our initial peptides will be performed in additional volunteers.
The Company has a number of peptide vaccines in development for infectious agents, oncology and autoimmune indications that are based upon the same technology platform as their avian influenza vaccine. The most advanced is an immunotherapeutic vaccine currently in Phase II clinical trials in patients with breast cancer. That peptide has similarly been shown to be safe and well-tolerated in all patients that received it. Specific immunological responses consistent with antigen-specific T helper cell stimulation have been observed in immunized patients.
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 (Generex Oral-lyn(tm)), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, 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 http://www.generex.com or the Antigen Express website at http://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:
CEOcast, Inc.
For Generex:
Gary Nash
212-732-4300
American Capital Ventures, Inc.
Howard Gostfrand
305-918-7000
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300,
kensgro@ceocast.com, for Generex Biotechnology Corporation
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