Generex Biotechnology's Oral-lyn matches fast-acting insulin in study
Generex Biotechnology Corp. reported results of a recently completed Phase IIb clinical study of Oral-lynT in which Oral-lynT successfully replaced rapid-acting insulin in patients with type-1 diabetes mellitus.
This is the first report in which patients with type-1 diabetes, using glargine insulin (LantusR) as their baseline therapy, have been maintained with optimal control using a schedule of meal oral insulin -- Generex's Oral-lyn -- during a period of 9 days. Unlike injection or various pulmonary delivery methods (in which a powdered or liquid insulin formulation is inhaled into and absorbed by the lungs), Oral-lyn is delivered as a fine spray to the buccal (oral) cavity via the Company's proprietary Rapidmist delivery system. The result is rapid insulin absorption through the buccal mucosal lining of the mouth without pulmonary (lung) exposure or the pain and inconvenience of needles.
"This study demonstrates that patients with type-1 diabetes who manage their disease on a daily basis using Oral-lynT and their usual long-lasting injectible insulin overnight were able to maintain glucose levels in the same fashion as they were using daily mealtime injections," said Dr. Gerald Bernstein, Generex's Director of Medical Affairs. "Clearly, the ease and convenience of the administration of Oral-lynT, combined with its ability to reproduce the effects of daily injections, can offer a profound increase in the quality of life of many patients with type-1 diabetes."
Other news from the department research and development
