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Monday, 02/04/2008 10:01:46 AM

Monday, February 04, 2008 10:01:46 AM

Post# of 353149
GNBT 1.35---GENEREX BIOTECHNOLOGY CP

Generex Biotechnology Announces That An Investigators' Meeting Was Recently Held for Its Global Phase III Clinical Trial of Generex Oral-lyn
2/4/2008

72 Clinical Centers to Participate in Phase III Study

WORCESTER, Mass., Feb 4, 2008 (PrimeNewswire via COMTEX News Network) --
Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that on February 1st, 2008, an Investigators' Meeting was held in St. Petersburg, Russia for the launch of the Company's global Phase III study for Generex Oral-lyn(tm). The Investigators' Meeting was attended by more than 150 clinicians and healthcare professionals.

There are 72 clinical centers in seven countries which have been selected by Generex to participate in the trial. The centers chosen by the Company are located in the USA, Canada, Russia, the Ukraine, Romania, Bulgaria and Poland.

The multi-center, randomized Phase III trial will include up to 750 patients with Type 1 diabetes mellitus. The primary objective of the study, Protocol GEN-084-OL, is to compare the efficacy of Generex Oral-lyn therapy using the Company's proprietary RapidMist(tm) Diabetes Management System with that of standard regular injectable insulin therapy as measured by HbA1c in patients with Type 1 diabetes mellitus. The results stemming from this trial will be submitted in support of applications for Generex Oral-lyn approval filed with Health Canada, EMEA and the FDA.

Generex Oral-lyn is a prandial (mealtime) insulin which allows for easy self-administration, precise dosage control and easy titration making possible finer, more individualized glucose control. As such, Generex Oral-lyn also makes an ideal supplement at meal times for patients with Type 2 diabetes mellitus in addition to basal therapies or combination therapies based on blood glucose measurements.

Generex believes that early intervention with insulin therapy could delay the onset and progression of diabetes and its numerous complications and thereby increase longevity.

"We are very pleased by the feedback from the Investigators' Meeting," said Anna Gluskin, Generex's President and Chief Executive Officer. "The enthusiasm evidenced by the large attendance in St. Petersburg illustrates the European and East European medical community's interest in and excitement about participating in this trial. After many months of meticulous preparations, Generex continues to steadfastly follow its course in order to bring a more convenient, compliance-friendly insulin alternative to patients," she added.

About Generex

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 for the treatment of patients with Type 1 and Type 2 diabetes and which was approved for sale in India in October 2007, is in various stages of clinical development around the world. For more information, visit the Generex website at www.generex.com.




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