Oral Insulin Spray, Oralin

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From http://www.pslgroup.com/dg/206e96.htm

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ALIGN="center"><B>EASD: Oral Insulin Spray, Oralin, May Be Effective Replacement for Insulin Injections in Diabetes</B></P>

TORONTO, ON -- September 24, 2001 -- Generex Biotechnology Corporation, a leader in the area of buccal drug delivery, presented promising data at the 37th annual meeting of the European Association for the Study of Diabetes (EASD) in Glasgow, Scotland, that suggests that Oralin?, Generex proprietary oral insulin spray, may be a safe and effective replacement for injected insulin in the treatment of Type-1 and Type-2 diabetes patients.

Oralin is delivered as a fine spray to the buccal (oral) cavity via Generex' RapidMist? device, where the formulation is rapidly absorbed through the buccal mucosa and into the bloodstream.

Dr. Pankaj Modi, Generex chief scientific officer, co-authored four studies that were presented at the EASD meeting, including one oral presentation and three poster presentations. Similar studies were presented by the company at the 2001 Meeting of the American Diabetes Association (ADA) earlier this year.

The oral presentation entitled "Early Introduction of Oral Insulin in Patients Failing on Diet and Exercise, A Long Term Efficacy Study in Treatment of Type-2 Diabetes," evaluated the fifteen-week efficacy of a low dose of oral insulin spray in patients failing on diet and exercise to improve post prandial glucose profile and HbA1c.

In a double blind, placebo controlled, randomized study, data indicating that Oralin can be used in diet- and exercise-failure patients to significantly improve HbA1c levels and achieve better glucose control.

The study entitled "Long-Term Efficacy of Oral Insulin and Pioglitazone Combination Therapy for Treatment of Type-2 Diabetes" evaluated the long-term (12 weeks or more) efficacy of low doses of oral insulin in combination with pioglitazone against placebo plus pioglitazone.

In a double blind, randomized study, type-2 diabetic patients failing on oral agents received oral insulin or placebo puffs in the buccal cavity via Generex' Rapidmist device in combination with pioglitazone tablets. The HbA1c levels were measured every two to four weeks. The data from the study showed that the HbA1c levels significantly improved in the group receiving oral insulin with pioglitazone when compared to the baseline group, thus indicating that oral insulin can be safely used on a long-term basis without any adverse effect to treat diabetes in place of injections.

The study entitled "Replacement of s.c. Injections with Oralin in Treatment of Diabetes" evaluated the efficacy of oral insulin versus subcutaneous injection to control post-prandial glucose in type-2 diabetic patients after a standard meal challenge.

In a single blind, randomized, crossover study, 11 type-2 diabetic patients received oral insulin buccally via Generex' Rapidmist device or subcutaneous injections of insulin, followed by 360 calories Sustacal meal 15 minutes after dosing. Patients received both treatments in replicate dosing. The data from the study showed no statistically significant differences between the treatments in terms of post-prandial glucose control after a standard Sustacal meal challenge, rise in plasma insulin levels and the suppression of C-peptide levels, indicating that Oralin can be used safely to replace mealtime injections to treat diabetes.

The study entitled "Oral Spray Insulin in Patients with Type 1 Diabetes: Comparison with Regular Insulin," indicated that Oralin administered via the buccal spray formulation is as effective as subcutaneous insulin injections in lowering blood glucose levels in patients with type-1 diabetes after a standard meal challenge.

The study consisted of two days comparing subcutaneous insulin treatment with oral insulin spray. On day one, patients received their usual dose of subcutaneous regular insulin, while on day two, subcutaneous insulin was replaced with the equivalent dose of oral spray insulin. On both days, capillary blood glucose, venous blood glucose, plasma insulin and C-peptide levels were measured every 30 minutes for two hours and then every 60 minutes up until the fourth hour. Results of this study showed that were no significant differences in blood glucose or insulin levels throughout the four hours after insulin administration between patients receiving the oral spray or the subcutaneous insulin formulation.

"We are quite pleased with the data we presented at the EASD meeting, as well as the ADA meeting earlier this year. All our presentations generated tremendous interest among leading diabetologists and researchers alike," stated Dr. Modi. "To date, our studies indicate that our proprietary oral insulin spray can be an effective replacement for injected insulin and an adjunctive therapy for variety of oral agents."

SOURCE: Generex Biotechnology Corporation