Generex Biotechnology Corp. (fka GNBTQ)

[WeeZuhl]

We have a pulse! Breath damnit BREATH!!

http://www.prnewswire.com/news-releases/generex-provides-update-on-success-of-buccal-insulin-formulation-enhancement-project-300132713.html

Generex Provides Update on Success of Buccal Insulin Formulation Enhancement Project


WORCESTER, Mass. and TORONTO, Aug. 25, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today provided an update on the status of the buccal insulin formulation enhancement project for the Company's proprietary Generex Oral-lyn™ buccal insulin spray product. As previously announced, Generex engaged the University of Toronto's Center for Molecular Design and Pre-formulations (CMDP) (www.cmdp.uhnres.utoronto.ca) through the University Health Network (www.uhn.ca) with the goal of enhancing the Generex Oral-lyn™ formulation to make it more attractive to patients and prospective commercialization partners by increasing the bioavailability of insulin in the product and reducing the number of sprays required to achieve effective prandial metabolic control for patients with diabetes.

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Dr. Brusegard commented: "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."

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In the dogs given the enhanced Generex Oral-lyn™ formulation, there was a 9-fold increase in serum insulin at 15 minutes (excluding one dog who had little response) and almost 500% greater absorption of insulin over the two-hour test period compared to dogs given the original formulation. There was a 33% decrease in serum glucose at 30 minutes in dogs treated with the enhanced Generex Oral-lyn™ formulation, compared to a 12% increase in serum glucose in dogs treated with 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," said Dr. Anderson.

Generex Oral-lyn™ is designed to be a safe, simple, fast, flexible, and effective alternative to prandial insulin injections in people with either type 1 or type 2 diabetes mellitus.