Generex Biotechnology Corporation (Nasdaq:GNBT), (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has now achieved 75% of the required number of per-protocol completers in its ongoing six month pivotal global Phase III study of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product. These early results suggest that, should the current trend be maintained through the early 2011 completion date of the treatment phase of all enrolled subjects, the use of Generex Oral-lyn™ will support a non-inferiority claim relative to the standard-of-care injectable insulin. This position will be reviewed following a formal interim analysis after the 90-day results for all subjects become available.
It is gratifying for the Company to see a continuum of positive trends. Initial trending outcomes revealed that insulin resistance was not observed for subjects using Generex Oral-lyn™ and that subjects using Generex Oral-lyn™ demonstrated, on average, no weight gain and an actual decrease in Body Mass Index (BMI). This compared favorably to subjects using injectable insulin that have, on average, gained weight and experienced an increase in BMI. In addition, it was previously reported that when comparing hypoglycemic events, subjects using Generex Oral-lyn™ were observed to have a better Adverse Event profile than subjects using injectable insulin. These previous findings along with current trends of non-inferiority using recently collected information and extrapolations clearly positions this study favorably.
"This latest study trend is exciting news for us," said Anna Gluskin, the Generex President & Chief Executive Officer. "The Phase III study is on track and we will look forward to further analyses as we near completion of the study."
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