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Re: **D*A** post# 57183

Tuesday, 03/23/2010 8:56:37 AM

Tuesday, March 23, 2010 8:56:37 AM

Post# of 126111
GNBT doesn't take the hachet job lightly.:)

Generex Biotechnology Demands Retraction of False and Misleading Article
Company Sets Record Straight on Misinformation Spread by TheStreet.com


Companies:Generex Biotechnology Corp.
Press Release Source: Generex Biotechnology Corp. On Tuesday March 23, 2010, 8:30 am

WORCESTER, Mass., March 23, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT - News) (http://www.generex.com/) has demanded a retraction of and apologies for the inaccuracies in an online article published to TheStreet.com on March 19. In an entry titled "Biotech Stock Mailbag: Generex," TheStreet.com columnist Adam Feuerstein makes erroneous claims about Generex and its flagship product Generex Oral-lyn(TM), an oral insulin spray currently in Phase III clinical trials for the treatment of Type I and Type II diabetes. Generex also wishes to correct the public record by making clear the facts as outlined in the letter to TheStreet.com's counsel:



The article states, "Nifty technology, except none of the Oral-Lyn data collected by Generex has not been peer-reviewed in credible medical journals, nor has it been presented at the top-flight diabetes meetings."



FACT: A number of independent, peer-reviewed studies of Generex Oral-lyn(TM) have been published in journals including Diabetes Care. In addition, Generex Oral-lyn(TM) trial data has been presented in podium posters and abstracts at the annual meetings of the American Diabetes Association (ADA), The Endocrine Society, the European Association for the Study of Diabetes (EASD) and the International Diabetes Federation (IDF) on a regular basis over the past ten years.


The article indirectly attributes to a third-party source that he "is a skeptic because absorption of insulin through the lining of the mouth is too erratic and potentially dangerous."



FACT: Scientific data contradicts such statements, underscored by the U.S. Food & Drug Administration (FDA) stamp of approval on Generex Oral-lyn(TM) with its inclusion in the Treatment Investigational New Drug (IND) program. The absorption of insulin through the buccal mucosa is much more consistent than through subcutaneous injection, because it is absorbed directly into the blood stream. Absorption through subcutaneous injection is less consistent, as insulin collects at the injection site while it is being absorbed.


The article states, "Oral-Lyn is approved as an alternative to insulin injections in Ecuador, India, Lebanon and Algeria, claims Generex, although the company has not yet recognized revenue from the product."



FACT: Pursuing regulatory approvals overseas is an ordinary course of action for biotech and pharma companies while the U.S. FDA process in ongoing. The company will continue to pursue regulatory approvals around the globe while the Phase III study continues.


The article quotes a third-party source, "Oral insulin, respiratory insulin, buccally delivered insulin are all marketing driven technologies, they are not driven by the real need of diabetes patients."



FACT: Multiple independent studies published in Diabetes Research and Clinical Practice, Diabetic Medicine and other journals demonstrate that non-injectable insulin does address a real need of diabetes patients.


Generex Oral-lyn(TM) delivers insulin via the membranes of the oral cavity by a small device that looks like an asthma inhaler. However, unlike inhaled insulin, there is no pulmonary (lung) deposition, nor does the insulin ever enter the GI tract; it is absorbed directly into the bloodstream through the lining of the mouth. Generex Oral-lyn(TM) is in Phase III clinical trials at multiple sites in the U.S. and around the world.



About Generex Biotechnology Corporation



Generex is engaged in the research, development and commercialization 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 has been launched in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. 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/.



The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831



Safe Harbor Statement



This release and oral statements made from time to time by Generex representatives in respect of 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. 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.






http://finance.yahoo.com/news/Generex-Biotechnology-Demands-pz-3771542556.html?x=0&.v=1

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