Generex Biotechnology Appoints Leading Contract Research Organization to Manage Global Phase III Trials For Generex Oral-lyn
Company Also Selects Other Key Service Providers to Support Upcoming Site Selection and Patient Enrollment
WORCESTER, Mass., Oct 16, 2007 (PrimeNewswire via COMTEX) -- Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has 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") (www.psi-cro.com), 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. (www.nextrials.com), which will be responsible for providing Electronic Data Capture, randomization, 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 eResearchTechnology, Inc. (Nasdaq:ERES) (www.ert.com), a market leader in providing centralized electrocardiographic (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 has procured each of these service providers through the efforts of OSMOS Clinical Research, Inc. (www.osmos.us) of San Francisco, California, which 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-center clinical study, where enrollment 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(tm) Diabetes Management Sytem 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 enrollment," said Anna Gluskin, Generex's President and Chief Executive Officer. "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 commercialization of Generex Oral-lyn in North America."
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 www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning 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 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.
This news release was distributed by PrimeNewswire, www.primenewswire.com
SOURCE: Generex Biotechnology Corp.
By Staff
CONTACT: Generex Biotechnology Corporation
Shayne Gilliatt
800-391-6755
416-364-2551
CEOcast, Inc.
Andrew Hellman
212-732-4300
