Generex Biotechnology Corporation recently provided updates on the company’s proprietary Generex Oral-lyn™ technology, a buccal insulin spray product. As previously reported, Generex has engaged the Center for Molecular Design and Preformulations (CMDP) at the University Health Network in order to enhance the Generex Oral-lyn™ formulation so it can be more effective in both patients and commercialization partners by increasing the bio-availability of insulin in the product and improving prandial metabolic control for patients suffering with diabetes.
The project was initiated under the supervision of Generex’s Chief Operating Officer David Brusegard, James Anderson, Jr., the Company’s Senior Scientific Advisor, and Generex consultant Lakshmi P. Kotra, B. Pharm.(Hons).
Brusegard stated in a press release: “We are pleased to report that our preliminary efforts have succeeded in increasing the insulin concentration in the product by approximately 400 percent via in vitro testing while preserving the solubility and stability of insulin in the formulation.”
Generex entered into a Research Service Agreement with the University of Guelph wherein the University will conduct an assessment of the relative bio-availability of the improved formulation in dogs at the University’s Comparative Clinical Research Facility. Dogs allow easier administration of the drug, and results of the biochemical analysis of the blood are expected to highlight its impact on treating humans. A direct comparison between the studies in dogs and the original formulation of Generex Oral-lyn™ will support evaluation of the safety, concept and toxicity.
“We are happy with the initial results of this project. If the data from the dog study bears out our expectations, the next step will be an update to the Generex Oral-lyn™ IND on file with the USFDA in support of the human studies necessary to validate the enhanced formulation and set the stage for commercialization,” commented Anderson.
Generex Oral-lyn™ is believed to be a simple, safe, fast, effective and flexible alternative to after meal insulin injections. Generex Biotechnology Corporation is a company committed to research, development, and marketing of drug delivery systems, techniques and technologies that might improve the quality of life of those that suffer from various diseases.