Symposium Will Focus on the On-going Global Phase III Trial
of Generex Oral-Lyn, the Company's Proprietary Oral Insulin 3
Spray Product
260 Patients are Currently Enrolled at 69 Sites in Seven Countries
WORCESTER, Mass., Oct. 29, 2008 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (http://www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that, in addition to making three poster presentations of clinical data, it will host a satellite symposium at the 2nd World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension (www.codhy.com) being held in Barcelona, Spain October 30 - November 2, 2008.
Generex's satellite symposium, entitled Innovations in Insulin Delivery for Postprandial Glucose Control, will take place on October 30, 2008 from 14:00 to 16:00 CET in Mare Nostrum A, B, C - Rey Juan Carlos Hotel. The symposium will be chaired Professor Itamar Raz, the Chair of CODHy 2008 and Head of the Diabetes Unit, Department of Medicine, Hadassah University Hospital, Ein-Karem, Jerusalem.
The symposium will feature presentations by Dr. Jaime Davidson, Generex's Medical Director, Dr. Gerald Bernstein, the Company's Vice-President for Medical Affairs, Professor Paolo Pozzilli of University Campus Bio-Medico, Rome, Italy and Professor Philip Raskin of the University of Texas Southwestern Medical Center, Dallas, Texas.
Professor Raskin, one of the independent principal investigators in Generex's ongoing global Phase III clinical trial of Generex Oral-lyn(tm), the Company's proprietary oral insulin spray product, will examine the protocol for the Phase III trial wherein the safety and efficacy of Generex Oral-lyn(tm) (delivered into the mouth using the Company's proprietary RapidMist drug delivery system with no pulmonary deposition) is being compared to standard regular injectable insulin therapy in subjects with Type 1 diabetes using twice daily NPH as basal insulin.
Preliminary indications are that Generex Oral-lyn(tm) is at least as effective as standard regular injectable insulin therapy. The Company believes that Generex Oral-lyn(tm), as a safe, convenient, simple, fast, effective, familiar and pain-free alternative to prandial insulin injections, offers the prospect of a new paradigm for the treatment of diabetes which may delay the progression of the disease and the onset of its myriad complications.
To date, 260 subjects have been enrolled in the Phase III trials at 69 sites in seven countries.
In addition, three poster presentations of the results of studies sponsored by the Company will be made as follows:
* Is Serum Fructosamine An Adequate Measurement For Monitoring Long-Term Metabolic Control In Type 1 Diabetes?, co-authored by J Guevara-Aguirre, M Guevara-Aguirre and J Saavedra of the Institute of Endocrinology IEMYR, Quito, Ecuador, AL Rosenbloom of the University of Florida, Gainesville, E Vidgen of the University of Toronto, and Dr. Gerald Bernstein, Generex's Vice-President for Medical Affairs.
* Is Human Insulin Therapy As Efficacious As Insulin Analogs In The Treatment Of Type 1 Diabetes?, co-authored by J Guevara-Aguirre, M Guevara-Aguirre and J Saavedra of the Institute of Endocrinology IEMYR, Quito, Ecuador, AL Rosenbloom of the University of Florida, Gainesville, and Dr. Gerald Bernstein, Generex's Vice-President for Medical Affairs.
* The PREDICA Study (PREdiction of Diabetes from CApillary Blood Glucose) in the General Population, co-authored by Antonio Picardi, Flavia Costanza, Nicola Napoli and Paolo Pozzilli of University Campus Bio-Medico, Rome, Italy, Enrico Di Stasio of Catholic University, Rome, Italy, and Francesco Carrano, Vincenzo Dell'Anna and Walter Macino of Federazione Medici di Medicina Generale, Rome & Frosinone, Italy.
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 is available for sale in Ecuador and approved for sale in India for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at http://www.generex.com.
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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.