Generex Biotechnology Corporation recently presented an update on the status of a buccal insulin formulation enhancement project for Generex Oral-lyn™, the company’s proprietary buccal insulin spray product to address the medical needs of diabetes patients.
As had been previously announced, Generex partnered with the University of Toronto’s Center for Molecular Design and Pre-formulations (CMDP) thanks to the University Health Network with the objective of improving the Generex Oral-lyn formulation by improving ease of use for incrusted patient compliance. The company also worked with its commercialization partners to augment the insulin’s bio-availability while at the same time reducing the amount of sprays required to achieve effective prandial metabolic control for those suffering with diabetes.
The project was conducted under the supervision of the company’s Chief Operating Officer David Brusegard, as well as James H. Anderson, the Company’s Senior Scientific Advisor, and Lakshmi Kotra, a Generex consultant.
“We are pleased to report that our preliminary efforts have succeeded in increasing the insulin concentration in the product by approximately 400 to 500 percent as confirmed by a variety of in vitro testing procedures while preserving the solubility, stability, and biologic activity and potency of the insulin in the formulation,” Brusegard said.
Generex signed a Research Services Agreement with the University of Guelph to assess the relative bio-availability of the enhanced formulation in a study involving dogs. The enhanced formulation of Generex Oral-lyn™ was compared with the original one and no adverse events were observed in the animals.
Researchers observed that in the dogs that received the enhanced Generex Oral-lyn™ formulation, a 9-fold increase in serum insulin at 15 minutes and nearly 500 percent higher absorption of insulin over the 2-hour test period was verified in comparison to dogs that received the original formulation; a 33 percent decrease in serum glucose around minute 30 for the enhanced Generex Oral-lyn™ formulation was noted in comparison to a 12 percent increase in serum glucose in those that received the original formulation.
“The outstanding results of these dog studies coupled with the positive findings from the in vitro work provide support and confidence to move forward as quickly as possible with the remaining clinical and regulatory work necessary to achieve FDA approval of the enhanced Generex Oral-lyn™ formulation,” noted Dr. Anderson.
Generex Oral-lyn™ is believed to be simple, safe, flexible, fast, and effective alternative to prandial insulin injections in patients suffering with type 1 or type 2 diabetes mellitus.