Generex starts study of Oral-lyn insulin spray in teenage patients with type-1 diabetes

By E. Janene Geiss

Philadelphia, Jan. 9 - Generex Biotechnology Corp. said Monday that it has started a six-month study of Oral-lyn, the company's proprietary oral insulin spray product, in teenage patients with type-1 diabetes mellitus.

The objective of this new study is to compare the use of Oral-lyn versus short-acting subcutaneously injected pre-prandial insulin (Humulin) by the young patients at lunchtime during a 30-day period followed by a six-month replacement of Humulin with Oral-lyn at lunchtime, according to a company news release.

The company previously reported the successful replacement, during a 12-day period, of Humulin with Oral-lyn in 10 adult patients with type-1 diabetes mellitus

As in the previous study, the new study involves an Oral-lyn split-dose treatment, or the application of Oral-lyn spray both before and after each meal, officials said.

Generex said it believes this approach offers a new treatment paradigm by offering improved efficacy because Oral-lyn is better at mimicking the healthy body's natural insulin production. It also offers the potential for improved patient compliance because there are no painful injections.

The study will demonstrate the application of that paradigm on a long-term basis in adolescents with type-1 diabetes, a very challenging group to treat successfully, officials said.

The study is taking place at the Institute of Endocrinology in Quito, Ecuador and the principal investigator is Jaime Guevara-Aguirre.

All of the participants in the study were referred to the institute for treatment by physicians in the South American medical community, officials said. The participants include 11 male adolescents and 11 female adolescents with a mean age of 14.4 years and a mean Body Mass Index of 21.3. Also included are five young adults with a mean age of 18.6 years and a mean BMI of 24.1. The mean age of the entire participant group is 15.2 years and the mean duration of the diabetes mellitus is 6.2 years, officials said.

Because the study participants were referred to the institute in varying states of metabolic control, it was appropriate to stabilize them using standardized methodologies prior to the commencement of the study, officials said.

Generex said it believes that Oral-lyn can make a significant contribution to the achievement and maintenance of metabolic stabilization by providing simple, effective and flexible alternative to pre-prandial insulin injections.

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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