WORCESTER, Mass. and TORONTO, Aug. 25, 2015
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. The project moved forward under the supervision of Dr. David Brusegard, Ph.D., the Company's Chief Operating Officer, Dr. James H. Anderson, Jr., MD, the Company's Senior Scientific Advisor, and Generex consultant Dr. Lakshmi P. Kotra, B. Pharm.(Hons), Ph.D., of CMDP.
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."
Generex subsequently entered into a Research Services Agreement with the University of Guelph (www.uoguelph.ca) pursuant to which Dr. Dana Allen, DVM, MSc. and Dr. Ron Johnson, DVM, Ph.D. of the Ontario Veterinary College of the University of Guelph conducted a study of the relative bioavailability of the enhanced formulation in dogs in the University's Comparative Clinical Research Facility. The University had previously conducted the studies of the original formulation of Generex Oral-lyn™ for proof of concept, safety, and toxicity.
In the new studies, the enhanced Generex Oral-lyn™ formulation was compared with the original formulation in a blinded, parallel controlled study involving fasted, awake, healthy mature beagle dogs. Each dog received three sprays of either the enhanced formulation or the original formulation. Each dog was observed with assessments of serum insulin and glucose measured over a two-hour period. There were no adverse events observed in any of the animals.
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.
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
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SOURCE Generex Biotechnology Corporation