Generex Biotechnology Reports Preliminary Outcomes and Trends from Ongoing Phase III Clinical Trial of Generex Oral-lyn

Findings based on in-process data for subjects that completed the 6-month treatment phase of the study demonstrate several favorable comparisons to injectable insulin

08-Jun-2010 - USA

Generex Biotechnology Corporation reported preliminary outcomes and trends from the ongoing Phase III pivotal study of Generex Oral-lyn™, the Company’s proprietary oral insulin spray product.

Observations were made regarding insulin antibody levels, weight gain, body mass index, and hypoglycemic events. Information on reported trends has been collected from in-process, non-finalized data. With over 400 subjects now enrolled in the Phase III global clinical trial of Generex Oral-lyn™, a brief look at open data from the Electronic Data Capturing System (EDC) reveals the following for subjects that completed the 6-month treatment phase of the study:

Insulin resistance has not been observed for subjects using Generex Oral-lyn™. Subjects using Generex Oral-lyn™ demonstrated no weight gain, on average, and an actual decrease in Body Mass Index (BMI). This compares favorably to subjects using injectable insulin that have, on average, gained weight and experienced an increase in BMI. When comparing hypoglycemic events, subjects using Generex Oral-lyn™ were observed to have a better Adverse Event profit than subjects using injectable insulin. Furthermore, there have been fever severe hypoglycemic events for those using Generex Oral-lyn™ than those using injectable insulin.

“We are very pleased that these key characteristics often monitored throughout insulin treatments are trending favorably,” stated Anna Gluskin, Generex’s President & Chief Executive Officer. “As weight gain and hypoglycemic events are often negative side effects of injectable insulin, it is extremely encouraging that regular administration of Generex Oral-lyn™ has been observed to result in a decrease in BMI and fewer severe hypoglycemic events.”

These reported trends and outcomes are preliminary only. Once approximately 450 subjects are enrolled in the study, a formal interim analysis of the collected data is planned.

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