Oral Insulin “Oral-lyn” Phase III Study Shows Positive Results

Generex Biotechnology Corporation, a leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced positive results following the review of the Phase III data for the company’s flagship product, Generex Oral-lyn, a proprietary oral insulin spray product designed to replace prandial injections of insulin.

Generex, together with the company’s independent third party statistical and data monitoring consultants, will continue to monitor the ongoing pivotal Phase III Generex Oral-lyn study according to protocol and national/international ICH-GCPs.  To date, more than 300 subjects have been enrolled in the study (with 60 subjects having achieving the requisite six month treatment milestone) and the product’s non-inferiority to injectable meal-time (prandial) insulin appears to be maintained.  If the current positive trend is maintained, then a large reduction of required enrollment will suffice for formal verification of the non-inferiority hypothesis.

The current data also demonstrates that no significant Generex Oral-lyn drug-related “Adverse Events” or “Serious Adverse Events” have been reported, which also supports the current initiatives of the study. 

“The current data and trends represent a critical milestone for the company,” said Anna Gluskin, Generex’s President and Chief Executive Officer.  “These results are consistent with the results of our previous studies. This will allow us greater flexibility in our strategies for filing submissions with regulatory authorities in major global markets and other jurisdictions where applications are already in progress.”

The company believes that Generex Oral-lyn will offer a safe, simple, fast, effective and pain-free alternative to prandial insulin injections which will improve patient compliance with therapeutic regimes thereby delaying the progress of diabetes and the onset of its myriad complications.

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™ device.  The company's flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in India and Ecuador for the treatment of subjects with Type 1 and Type 2 diabetes, is in Phase III clinical trials at several sites around the world.   http://www.generex.com.