Generex reports preliminary positive results with Oral-lyn in juvenile patients

By Ted A. Knutson

Washington, March 8 - Generex Biotechnology Corp. reported positive preliminary results Wednesday after 10 weeks of a long-term, six-month clinical trial of Generex Oral-lyn, the company's proprietary oral insulin spray product, in juvenile patients with type-1 diabetes mellitus (DM).

The investigators concluded that during the first 2.5 months of this ongoing six-month trial, replacement of subcutaneous injections of regular insulin by Generex Oral-lyn at lunchtime in adolescent and young adult patients with type 1 DM was associated with overall adequate glycemic control and similar fructosamine and glycosylated hemoglobin (HbA1c) concentrations.

The company previously reported the successful replacement, during a 12-day period, of subcutaneously injected pre-prandial regular insulin with the drug in 10 adult patients with type 1 DM.

The objective of this new study is to document the effects of replacing the lunchtime dose of subcutaneous injected regular insulin with Generex Oral-lyn in juvenile type 1 DM patients.

A comparison between the two different insulin preparations was done initially for three to four weeks, followed by a six-month replacement period with Generex Oral-lyn at lunchtime.

As in the previous study, this new study involves a Generex Oral-lyn split-dose treatment, i.e., the application of Generex Oral-lyn spray both before and after each meal.

The company believes that this approach offers a new diabetes treatment paradigm by offering improved efficacy as Generex Oral-lyn is better at mimicking the healthy body's natural insulin production and patient compliance since there are no painful injections which resulted in greater metabolic stability thereby better controlling diabetes and reducing the complications associated with it.

Treatment of adolescents with type 1 DM is challenging, and Generex chose to replace the lunchtime dose because it is this dose that is most frequently associated with non-compliance.

Generex is a Toronto-based biotechnology company.

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