GENEREX BIOTECHNOLOGY PRESENTS ORAL INSULIN CLINICAL DATA AT THE 41ST ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES
Toronto 9/14/2005 08:00 AM GMT (TransWorldNews)
Data shows that Oral-lyn and HumulinR induced similar glucodynamic responses.
TORONTO, Canada September 14, 2005 Generex Biotechnology Corporation (NasdaqSC: GNBT), a leader in the area of buccal drug delivery, today announced clinical trial results presented at the 41st Annual Meeting of the European Association for the Study of Diabetes (EASD) held in Athens, Greece this week.
Dr. Jaime Guevara-Aguirre, of the Institute of Endocrinology IEMYR in Quito, Ecuador and one of the principal investigators in the Company's on-going clinical trials of Oral-lyn, its proprietary oral insulin spray product, made a presentation of Oral-lyn clinical trial results titled A 12-Day Comparison of Preprandial HumulinR vs. Oral-lyn in 10 Type 1 Diabetic Subjects Receiving Baseline Glargine Insulin Therapy.
Dr. Guevara-Aguirre acknowledged the prior contributions of the pioneering studies undertaken by Professor Paolo Pozzilli, head of the Department of Endocrinology and Diabetes at of University Campus Bio-Medico, Rome, Italy (see Biokinetics of buccal spray insulin in patients with type 1 diabetes published in Metabolism Clinical and Experimental, Volume 54, Issue 7 (July 2005)) and by Professor Itamar Raz of the Diabetes Unit, Department of Internal Medicine, Hadassah-Hebrew University Hospital, Jerusalem, Israel (see Comparison of Pharmacokinetic and Pharmacodynamic Properties of Single-Dose Oral Insulin Spray and Subcutaneous Insulin Injection in Healthy Subjects Using the Euglycemic Clamp Technique published in Clinical Therapeutics, Volume 26, Number 12 (December 2004)).
The aim of study was to determine the suitability of dose and formulation of Oral-lyn for its use in a larger multi-center trial. The study also compared the glucodynamics of both rapid insulins (Oral-lyn and HumulinR) in 10 subjects with Type-1 diabetes receiving glargine insulin as a baseline therapy. Fructosamine, a parameter of protein glycation, was determined as part of a panel of safety monitoring.
Subjects received their usual baseline glargine insulin therapy (2/3rds in the morning and 1/3rd in the evening). Depending on present glycemia, HumulinR was dosed as a pre-meal subcutaneous injection during days -3, -2 and -1. Five to eight puffs of Oral-lyn were given pre- and post- prandially on days +1 through +9. Adjustments of glycemia were done using standard snacks, additional subcutaneous HumulinR or Oral-lyn puffs.
The study found that HumulinR and Oral-lyn induced similar glucodynamic responses during the 12-day observation period (see graph below). Intensive monitoring and timely corrections resulted in an appropriate glycemic control as assessed by individual daily-glycemic curves and, especially, normal preprandial glycemia. Measurements of protein glycation displayed a tendency to lower values after the 12-day study period.
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 Companys proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Companys proprietary RapidMist device. The Companys flagship product, oral insulin (Oral-lyn), 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.
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 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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