Generex Provides Clarification of Facts

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Generex Biotechnology Corporation
GNBT
today provided a clarification of facts arising out of a blog post on Friday, June 24, 2011. Following that blog post, the price of the Company's common stock fell more than 20% and more than 4 million shares were traded. The author of the blog post made reference to information Generex provided to the marketplace in a press release eight days earlier (on June 16, 2011). Generex management feels it necessary and appropriate to clarify certain assertions made by the author in the blog post that, in the opinion of Generex, mischaracterize certain facts regarding Generex and the progress of Generex Oral-lyn™, the Company's proprietary oral insulin spray product. Generex "closed" the recent Phase III clinical trial of Generex Oral-lyn™ because the trial had been completed in accordance with the clinical trial protocol. The blog author's assertion that Generex "shut down" the trial inappropriately implies that the trial was curtailed or flawed, which is not the case. Further, the trial was completed on schedule in accordance with the clinical trial protocol. The June 16 Generex press release stated: "Generex clinical trial 084 in patients with type 1 diabetes will be closed to allow a final data analysis to guide future clinical trial plans. Interim results demonstrated that the type 1 patients treated with Generex Oral-lyn™ maintained metabolic control (hemoglobin A1c) over the 12 month duration of the trial." In short, these results validated our proprietary buccal insulin delivery technology. Generex disclosed the positive interim findings of the Phase III trial at the annual meeting of stockholders on June 8, 2011 and outlined how it has begun to execute on a comprehensive strategy to achieve FDA approval of Generex Oral-lyn™. Today, Dr. Anderson, an independent member of the Generex Board, commented: "The Company's scientific team is confident that our clinical and regulatory program is designed for success, and we intend to conduct a broader study to include a wider patient population in both type 1 and type 2 diabetes." The full presentation from the annual meeting of stockholders' is available for viewing on the Generex website at www.generex.com. Mark Fletcher, Generex President & Chief Executive Officer, stated: "We have made great strides in establishing a top notch scientific team at Generex and, as a result, have established a realistic and focused plan to realize success in the future for the largest possible patient population. The closing of the current Phase III study and the data we obtain from it will further that effort. Generex Oral-lyn™ has demonstrated efficacy and safety in all of the studies conducted to date."
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