Generex Biotechnology announces positive interim results of oral insulin spray trial

By Lisa Kerner

Erie, Pa., April 10 - Generex Biotechnology Corp. said interim three-month results of a six-month clinical trial performed in 24 adolescents and five young-adult patients with type-1 diabetes mellitus (DM) showed that replacing one once-daily subcutaneous injection of regular insulin with Generex Oral-lyn oral insulin spray improved metabolic control similarly to intensively monitored standard therapy.

Daily glucose profiles and fructosamine (a test of blood sugar) demonstrated improved values, while glycosylated hemoglobin (HbA1c) showed a significant improvement when compared to standard therapy, according to a company news release.

The investigators concluded that successful replacement of injected regular insulin at lunchtime was achieved with Generex Oral-lyn with 100% compliance.

Generex-Pharmabrand said it plans to design studies using a larger number of type-1 DM subjects and replacing the three mealtime doses of regular insulin with the Generex-Oral-lyn spray on subjects maintained in once-daily glargine insulin therapy.

The three-month data was presented in a week-long training seminar for the PharmaBrand SA sales force in preparation of Oral-Lyn's nationwide marketing.

Toronto-based Generex is engaged in the research and development of drug-delivery systems and technologies.

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