Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today 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 fewer 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.
While the Phase III global study continues, Generex Oral-lyn™ remains available under the Treatment IND program in the United States. In September 2009, the FDA granted approval to Generex to proceed with the treatment use of Generex Oral-lyn™ under the Treatment IND program, pursuant to which the product can be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company's Phase III study of the product. The Treatment IND program is open to eligible patients in the USA who comply with the selection criteria of the treatment protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for the program.
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