Generex Biotechnology Demonstrates Efficacy of Oral Delivery of Insulin at American Diabetes Association's 64th Annual Meeting & Scientific Sessions
Oral-lynT Has Faster Onset and Shorter Duration Than Regular Insulin
TORONTO, June 8, 2004 -- Generex Biotechnology Corporation (Nasdaq: GNBT), a leader in the area of buccal drug delivery, announced today results from its presentation at the American Diabetes Association's 64th Annual Meeting & Scientific Sessions. The event took place from June 4-8, 2004 at the Orange County Convention Center in Orlando, Florida.
Generex's executives presented a poster titled "Pharmacodynamics and Pharmacokinetics of Dose Ranging Effects of Oral-lynT versus s.c. Regular Insulin in Type 1 Diabetic Subjects." The aim of the study was to evaluate the pharmacodynamic and pharmacokinetic properties and the dose ranging effects of a buccal spray insulin in comparison to s.c. insulin and placebo spray in patients with type 1 diabetes.
In this randomized, 5-way, crossover study, 5 subjects with type 1 diabetes received 4 different doses of buccal spray: placebo = 10 puffs; spray insulin = 5, 10 and 20 puffs and compared to 0.1 U/kg s.c. regular insulin, using euglycemic clamp. Oral-lynT had an earlier onset of action, an earlier peak and a shorter duration of action. The maximal effect was similar in s.c. insulin vs 20 puffs. The time to maximum insulin concentration was shorter for Oral-lynT compared to s.c. insulin. The maximum insulin levels were comparable in the s.c. vs 20 puffs of Oral-lynT.
The AUC0-120 and maximum insulin levels (12.6 +/- 9.6, 17.4 +/- 11.2 and 55.3 +/- 41.8 uU/ml, respectively, p<.05) proved a dose response relationship for the 3 doses of spray insulin. The poster concluded that Oral-lynT has a faster onset and a shorter duration of action compared to s.c. regular insulin, with the main effect in the first 2 hours and these characteristics are well suited for the management of the prandial glucose levels.
"These results demonstrate the potential for Oral-lynT," said Anna Gluskin, Generex's President & Chief Executive Officer. "Our data has yielded similar results across many trials, which is one of the reasons that we are confident as we prepare for a pivotal trial. We believe that Oral-lynT continues to offer the opportunity for prandial control of blood glucose."
Results from a second study were also presented. The purpose of the study was also to evaluate the pharmacodynamic and pharmacokinetic properties and the dose ranging effects of Oral-lynT in comparison to s.c. insulin and placebo spray in healthy subjects. In this randomized, 5-way, crossover study, 5 healthy volunteers were assessed over 5 test periods, 7 days apart and received 4 different doses of buccal spray: placebo = 10 puffs; spray insulin = 5, 10 and 20 puffs and a dose of 0.1 U/kg s.c. regular insulin under euglycemic clamp. Somatostatin was used in order to inhibit endogenous insulin and glucagon secretion.
Oral-lynT had an earlier onset of action, an earlier peak and a shorter duration of action (90.1 +/- 37 vs 305.6 +/- 51 min). A dose-response relationship was demonstrated by an increase in maximal glucose infusion rates ad in AUC0-120 with 5, 10, 20 puffs.
The time to maximum insulin concentration was shorter for the Oralin compared to s.c insulin. The results demonstrated that Oral-lynT had a faster onset and a shorter duration of action compared to s.c. regular insulin. A dose-response relationship in the absorption and metabolic effect of Oral-lynT was noticed.
Generex is engaged in the research and development of drug delivery systems and technology. To date, it has focused on developing a platform technology for the buccal delivery -- delivery to the oral cavity for absorption through the inner mouth mucosa -- of drugs that historically have been administered only by injection. Generex's buccal delivery technology has application to a large number of drugs.
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.
Shayne Gilliatt of Generex Biotechnology Corporation,
1-800-391-6755 or +1-416-364-2551; or Ken Sgro of CEOcast, Inc.,
+1-212-732-4300, or email@example.com, for Generex Biotechnology Corporation
Last Updated: Sunday June 13, 2004 14:49:58
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