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Generex Biotechnology Announces Commencement of a New European Clinical Study of Oral-Lyn(TM) in Patients With Type-1 Diabetes

Posted on: Tuesday, 10 January 2006, 09:00 CST

Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today that it has commenced a new European study of Oral-lyn, the Company's proprietary oral insulin spray product, in patients with Type-1 diabetes mellitus. The study, entitled "A 12-Week, Open-Label, Randomized, Active Comparator Study of Oral-lyn(TM) Spray and Injected Human Insulin in Patients with Type-1 Diabetes Mellitus," will be undertaken at The Department of Endocrinology and Diabetes at the University Campus Bio-Medico in Rome, Italy under the supervision of internationally renowned diabetes investigator Professor Paolo Pozzilli, MD.

The Diabetes Control and Complications Trial (DCCT) demonstrated that an improvement in blood glucose levels reduces the risk of long-term micro-vascular complications in patients with type-1 diabetes. However, the DCCT also demonstrated that intensive subcutaneous (injected) insulin therapy results in an increased frequency of hypoglycemia such that ideal blood glucose control is not achieved. In addition, for many patients, the idea of multiple or intensive insulin use is undesirable because of the pain and inconvenience associated with injections.

To a large extent, sub-optimal glucose control and the risk of hypoglycemia are a result of the pharmacokinetic properties of subcutaneously injected insulin. Insulin absorption is strongly affected by local factors such as the site of injection, the depth of injection, the temperature and permeability of the tissue, and whether the underlying muscle is exercising or not. Furthermore, the pharmacokinetics of insulin are affected by the amount of insulin given, with large doses resulting in delayed time to peak effect and longer duration of action.

Although new monomeric insulin analogues may result in a more rapid onset and a shorter duration of insulin action, no practical method has been found to control the multiple variables affecting injected insulin absorption. The inability of injected insulin administration to effectively, reproducibly, safely, and painlessly control postprandial glucose levels has motivated Generex's exploration of alternative methods of insulin delivery.

Generex has developed the RapidMist(TM) Diabetes Management System, which will be used to administer Oral-lyn. This system is based on a unique, proprietary formulation technology that provides a pain-free, needle-free, convenient method of administering insulin as a liquid pharmaceutical formulation delivered accurately into the mouth of the patient in the form of a spray. The fast-moving, fine particle aerosol easily traverses the thin membrane of the mucosal surface area of the oral cavity where it is absorbed into the blood stream and appears in the circulation within 10 minutes of the application of the spray. Oral-lyn(TM), as an Advanced Oral Drug Delivery platform, has a fundamental series of attributes: rapid access to the circulatory system; precise dosage control; simple self-administration procedure; and bolus drug delivery.

Previously published Phase 2 data from studies sponsored by Generex show that the speed of onset of the glucose-lowering response following Oral-lyn administration is consistent with that required for the achievement of postprandial glucose control. In particular, those studies demonstrated that Oral-lyn produces the desired rapid insulin uptake consistent that with required for dosing with a meal. Oral-lyn is a tasteless, liquid aerosol mist, which even after repeated administration, causes no irritation, burning, or discomfort in the mouth. In both long and short-term studies in patients with type-1 and type-2 diabetes undertaken in the USA, Canada, Europe, and South America, the onset of Oral-lyn action was earlier than that of subcutaneously injected insulin. Moreover, the studies demonstrated that Oral-lyn administration was successful in controlling postprandial glucose levels without relevant adverse events (no evidence of liver function changes, hematological changes, or severe hypoglycemia have been reported) and in the lowering of glycosylated hemoglobin (HbA1c) when compared to either standard subcutaneous injection therapy or oral agent therapy.

This new study of 60 adult patients with a history of type-1 diabetes mellitus in excess of one year and present intensive insulin therapy will evaluate the metabolic efficacy of Oral-lyn when administered at mealtimes in comparison to standard regular insulin therapy as measured by HbA1c. Following a baseline stabilization phase to determine optimal glargine and regular insulin doses, one group of patients will receive Oral-lyn in a split-dose fashion (half the dose immediately prior to the meal and the other half of the does immediately following the meal) at the optimal individualized dose. The other group of patients will receive regular insulin 30 minutes before meals and glargine insulin before the evening meal. All patients will remain on glargine therapy throughout the treatment period. Patients will consume regular meals and blood glucose levels will be measured four times each day (fasting level, before lunch, before dinner, and at bedtime).

About Generex

Generex is engaged in the research and development 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(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.

For more information, visit the Generex Web site at www.generex.com.

Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning 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,""plans,""intends,""believes,""will,""estimates,""forecasts,""projects" 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 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

 Contacts: Shayne Gilliatt Generex Biotechnology Corporation 1-800-391-6755 +1-416-364-2551  Ed Lewis CEOcast, Inc. +1-212-732-4300  

SOURCE: Generex Biotechnology

Source: MARKET WIRE

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