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Generex Biotechnology Completes Positive Pre-IND Meeting With FDA for Its Avian Flu Vaccine
Monday February 13, 7:15 am ET
Antigen Express Subsidiary Preparing for IND Filing
TORONTO--(MARKET WIRE)--Feb 13, 2006 -- Generex Biotechnology Corporation (NasdaqSC:GNBT - News) announced today that on February 10, 2006, Antigen Express, Inc., its wholly owned immunotherapeutics subsidiary, concluded a positive Pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding plans for the commencement of clinical trials of the proprietary and innovative Antigen Express vaccine to protect against the H5N1 avian influenza.
As a consequence of the Pre-IND meeting, Antigen Express has clarified the development path (including clinical study design) and regulatory timetable for its innovative vaccine. Prior to the submission of its IND, Antigen Express will conduct a toxicology study and a pre-clinical study to establish the vaccine's dosing regimen.
"We are very pleased with the outcome of our meeting with the FDA," said Dr. Eric von Hofe, President of Antigen Express. "We appreciate the extent to which the FDA will be engaged in this process and we look forward to its continuing guidance. We feel that this early intercession with the FDA will streamline our developmental and regulatory processes."
The Antigen Express avian influenza vaccine is based on a platform vaccine technology presently in human clinical trials in the form of a breast cancer vaccine. The breast cancer vaccine clinical trials are being undertaken at Walter Reed Army Medical Center (WRAMC), and a representative of WRAMC participated in this avian flu vaccine Pre-IND meeting with Antigen Express.
The Antigen Express vaccine is designed to induce a strong T-helper cell response using a synthetically manufactured peptide. A strong T-helper cell response plays a major role in helping the body to develop neutralizing antibodies to viral infections. Because the vaccine can be manufactured synthetically, it will be less expensive than cell-culture or hen-egg produced vaccines and it is possible to produce it in much larger quantities and much quicker using existing facilities. The induction of a good T-helper response is expected to greatly reduce the amount of classically produced vaccine necessary to achieve protective immunity in prime/boost regimens. The study will also attempt to establish whether application of the vaccine on its own will provide a significant degree of protection in humans who have received no other vaccination.
An Investigational New Drug Application (an "IND") is documentation that must be submitted to the FDA before a new drug (or biologic) can be used for human testing. The documentation includes evidence that the compound is biologically active and is safe for initial administration to humans in clinical investigations (i.e. pre-clinical efficacy, safety tests, pharmacology, dose ranging, manufacturing procedures, proposed first protocol). An IND is subject to an automatic 30-day review period.
Pre-IND meetings are conducted with the appropriate FDA review division that would review the drug marketing application (in this instance, the Center for Biologics Evaluation and Research) and these meetings are requested by the sponsor of a drug. Meetings at this stage in the process are useful opportunities for open discussion about testing phases, data requirements, and any scientific issues that may need to be resolved prior to IND submission.
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. for Generex Biotechnology
Phone: 1 (212) 732-4300
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Source: Generex Biotechnology |
