Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that it has engaged and entered into a number of key service agreements for its global phase III trials for Generex Oral-lyn, its proprietary oral insulin spray product.

Generex has selected PSI-CRO AG Clinical Research Services ("PSI"), a leading contract drug development company to serve as the company's global clinical research organization (CRO), to provide full-service CRO services with 600-full-time staff in Europe and North America.

Another key service provider selected and engaged by the company is Nextrials, Inc, which will be responsible for providing Electronic Data Capture, randomisation and data management services. Nextrials is an innovative, award-winning, leader in web-based software solutions for the clinical research industry. Generex has also entered into an agreement with eResearch Technology, Inc, market leader in providing centralized electro cardiographic (diagnostic) and cardiac safety services to supply equipment and provide central ECG services for the company's phase III trial. Negotiations with other key service providers and suppliers are ongoing and expected to be completed very soon, the company said.

The company has procured each of these service providers through the efforts of OSMOS Clinical Research, Inc. of San Francisco, California that Generex engaged earlier this year to assist the Company with the global project management of the phase III clinical trial.

The phase III global multi-centre clinical study, where enrolment is anticipated to commence shortly, is expected to include 750 patients with Type 1 diabetes mellitus. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the RapidMist 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 pleased at the progress the Company has made in securing quality service providers as we prepare to announce trial site locations and commence enrolment. We believe this study will demonstrate the success that other Type 1 and Type 2 patients have already experienced internationally and will pave the way for commercialisation of Generex Oral-lyn in North America," said Anna Gluskin, president and chief executive officer, 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).