Biotech Values

[DewDiligence]

GNBT to Advance Oral-Insulin Program to Phase-3

[This PR seems to imply that the phase-3 trial has an SPA from the FDA without actually saying so. If I were long, I would be concerned about the lack of clarity.]

http://biz.yahoo.com/pz/070625/121873.html

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Generex Biotechnology to Initiate Phase III Clinical Trial of Generex Oral-lyn in 2007 Third Quarter

Monday June 25, 9:10 am ET

Company to Commence Patient Dosing by Year-end

WORCESTER, Mass., June 25, 2007 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM: GNBT ), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today at the 67th Scientific Sessions of the American Diabetes Association in Chicago that the Company is preparing to commence a Phase III clinical trial of Generex Oral-lyn(tm), the Company's proprietary oral insulin spray product. The Company has been establishing regulatory and clinical management teams to execute the trials in the United States and abroad. The clinical trial will be undertaken pursuant to a Phase III protocol approved by Health Canada. The United States Food and Drug Administration's review period for the protocol recently lapsed without objection.

The Company expects to begin dosing patients before the end of the year in centers in the United States, Canada, and Europe.

The six month trial is expected to include 750 patients with Type 1 diabetes mellitus. Patient enrollment is expected to begin during the third or fourth quarter of calendar year 2007 and expand to several global centers over the course of the study. The primary objective of the study is to compare the efficacy of Generex Oral-lyn(tm) and the RapidMist(tm) Diabetes Management System with that of standard regular injectable human insulin therapy as measured by HbA1c, in patients with Type-1 diabetes mellitus.

``We are excited to be taking our flagship product into a pivotal Phase III trial, which we believe will represent the final step to achieving approval to market Generex Oral-lyn in North America and Europe,'' said Anna Gluskin, the Company's President & Chief Executive Officer. ``We enter this trial with a great deal of confidence that the results will validate the successful outcomes that patients have experienced in previous clinical trials. This milestone is the culmination of many years of research and development and many successful clinical trials and will set the stage for the global commercialization of Generex Oral-lyn.''

Generex has engaged OSMOS Clinical Research, Inc. (http://www.osmos.us) of San Francisco, CA to assist the Company with global project management of the Phase III clinical trial. OSMOS has an impressive client roster and over the past few years has provided clinical services for many successful clinical development programs.

In addition, the Company has engaged Beckloff Associates, Inc. (http://www.beckloff.com), a Cardinal Health company, to assist the Company with the Generex Oral-lyn Phase III study through the design and implementation of efficient global scientific and regulatory strategies. Beckloff provides a wide range of consulting services required to obtain marketing approval for drugs, biologics, and medical devices for the United States, Canadian, and European markets.

As previously announced, the Company has engaged Cardinal Health PTS, LLC to produce Generex Oral-lyn for clinical trials. Pursuant to pre-extant supply arrangements, the Company's third-party suppliers have been manufacturing the quantities of the RapidMist(tm) device components (valves, canisters, actuators, dust caps), the insulin, and the formulary excipients that will be required for the Cardinal Health production. In addition, the Company's Regulatory Affairs, Quality Control and R&D personnel have been working with Cardinal Health to prepare and validate the Cardinal Health production processes.

About Generex

Generex is engaged in the research and development 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 for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. For more information, visit the Generex website at http://www.generex.com .
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