WORCESTER, Mass. and TORONTO, June 27, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) (www.generex.com) 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.
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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.”
The June 16 Generex press release stated that the Company’s clinical and regulatory plan for Generex Oral-lyn will “focus on rapid registration in the North American major markets, with its rapid absorption and sharp peak in plasma insulin concentration mimicking normal insulin secretion, and Generex Oral-lyn’s short duration of activity reducing the potential for hypoglycemia. Studies will include a key activity/effect (pharmokinetic/glucodynamic) study using the final formulation and a series of small, well-designed phase 3 studies (potentially conducted as one study with multiple arms).” Generex management anticipates that these studies will be completed during 2013. Generex will also focus on studies that will measure Generex Oral-lyn’s ability to provide metabolic benefits that cannot be achieved with subcutaneously injected insulin such as prolonged reduction of over-production of glucose by the liver. The press release also stated that “a consensus meeting with the FDA to obtain agreement with the clinical plan and submission data package is planned this year to insure timely regulatory agency review and positive marketing approval.”
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 device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T helper stimulation in immunotherapy. One of its platform technologies relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
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,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” 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. Risks and uncertainties relating to the proposed reverse stock split include the risks that (1) Generex will not meet the standards for listing its common stock on a national stock exchange; and (2) Generex will not meet or sustain the minimum share price requirement of a national stock exchange. 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 or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any “phase” of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
SOURCE Generex Biotechnology Corporation
