Generex Provides Positive Update On Generex Oral-Lyn(TM) Pivotal Phase III Trial
WORCESTER, Mass., July 28, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT), ( www.generex.com ), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has now achieved 75% of the required number of per-protocol completers in its ongoing six month pivotal global Phase III study of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product. These early results suggest that, should the current trend be maintained through the early 2011 completion date of the treatment phase of all enrolled subjects, the use of Generex Oral-lyn™ will support a non-inferiority claim relative to the standard-of-care injectable insulin. This position will be reviewed following a formal interim analysis after the 90-day results for all subjects become available.
It is gratifying for the Company to see a continuum of positive trends. Initial trending outcomes revealed that insulin resistance was not observed for subjects using Generex Oral-lyn™ and that subjects using Generex Oral-lyn™ demonstrated, on average, no weight gain and an actual decrease in Body Mass Index (BMI). This compared favorably to subjects using injectable insulin that have, on average, gained weight and experienced an increase in BMI. In addition, it was previously reported that when comparing hypoglycemic events, subjects using Generex Oral-lyn™ were observed to have a better Adverse Event profile than subjects using injectable insulin. These previous findings along with current trends of non-inferiority using recently collected information and extrapolations clearly positions this study favorably.
"This latest study trend is exciting news for us," said Anna Gluskin, the Generex President & Chief Executive Officer. "The Phase III study is on track and we will look forward to further analyses as we near completion of the study."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. The Company's flagship product, buccal insulin (Generex Oral-lyn™), which has been approved 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 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 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.
CONTACT: American Capital Ventures, Inc. Investor Relations Contact Howard Gostfrand 1-877-918-0774 Beckerman Public Relations Christina Brozek 201-465-8002
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