Generex begins new trial of Ora-Lyn insulin spray in adults with type-1 diabetes

By E. Janene Geiss

Philadelphia, Jan. 10 - Generex Biotechnology Corp. said Tuesday that it has started a new European study of Oral-lyn, the company's proprietary oral insulin spray product, in patients with type-1 diabetes mellitus.

The study will be undertaken at the University Campus Bio-Medico in Rome under the supervision of internationally renowned diabetes investigator Paolo Pozzilli, according to a company news release.

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, officials said.

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, officials said.

The company also announced Monday that it will begin a similar clinical trial studying Ora-Lyn treatment on adolescents with type-1 diabetes.

The Diabetes Control and Complications Trial demonstrated that an improvement in blood glucose levels reduces the risk of long-term micro-vascular complications in patients with type-1 diabetes, the release said.

However, the trial also demonstrated that intensive subcutaneous (injected) insulin therapy results in an increased frequency of hypoglycemia such that ideal blood glucose control is not achieved. For many patients, the idea of multiple or intensive insulin use is undesirable because of the pain and inconvenience associated with injections, officials said.

Generex's RapidMist Diabetes Management System, used to administer Oral-lyn, offers an alternative to injections.

The system is based on a proprietary formulation technology that provides a pain-free, needle-free, 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 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, officials said.

Generex, based in Toronto, 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.

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