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Generex Biotechnology, and their wholly owned subsidiary Antigen Express, are developing promising new drugs to treat diabetes, as well as synthetic peptide vaccines targeting HER2/neu cancer and pandemic flu. The flagship product for Generex is Oral-lyn buccal insulin. Antigen Express' leading vaccine is the AE37 HER2/neu synthetic peptide vaccine to prevent breast cancer recurrence. I am not qualified to offer investment or medical advice, and make no claims that I am an expert in these areas. I am a layman and a shareholder in this company. The left side of Pipeline Review holds blogs regarding Generex and Antigen Express, while the right side offers items of due diligence mixed with my analysis which may be of interest to others seeking to learn about Generex's pipeline. If the left side only shows the latest blog, click on the word home to view them all.

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Sunday, July 22, 2012

Unusual Oral-lyn / IGT Data to be Presented at EASD 2012

The following abstract pertaing to an Oral-lyn study with subjects suffering fgrom impaired glucose tolerance will be presented at the 48th EASD Annual Meeting on October 3rd, 2012 in Berlin, Germany:

Title: Buccal spray insulin in subjects with impaired glucose tolerance: improvement in HbA1c is lost after 6 months wash out therapy

Presentation Time: Wednesday, Oct 03, 2012, 2:30 PM - 2:45 PM

Authors: A. Palermo1, N. Napoli1, E. Maddaloni1, A. Lauria1, A. Soare1, S. Manfrini1, M. Altomare2, S. Leotta2, P. Pozzilli1;
1University campus Bio medico, Roma, Italy, 2Hospital "S.Pertini", Roma, Italy.

Abstract: Background and aims: subjects who develop type 2 diabetes (TD2) pass through a phase of impaired glucose tolerance (IGT). Defects in the action or secretion of insulin are the two major abnormalities leading to development of glucose intolerance. Resistance to insulin progressively increases when passing from normal glucose tolerance through IGT to diabetes, whereas secretion of insulin gradually decreases. Glucose tolerance is assumed to remain normal as long as the beta cell secretion can compensate for insulin resistance. IGT will develop only when insulin secretion fails to compensate fully for such resistance, resulting in postprandial hyperglycaemia that is linked to an increased risk for cardiovascular disease even though there is no progression to diabetes. Many intervention trials have been conducted in IGT patients but only one aimed to decrease post prandial hyperglycaemia. Our previous proof of concept study in subjects with IGT undergoing a prolonged OGTT demonstrated that treatment with 12 puffs of buccal spray insulin was followed by a significant 29.6% decrease in mean plasma glucose at two-hours and a 26.8% decrease at three-hours. Based on these findings a short trial with buccul spray insulin was planed.

Materials and methods: We have designed a randomized controlled trial in patients with IGT comparing a 6 months duration therapy using buccal spray insulin (12 puffs per meal) plus physical exercise and diet (treatment group A, n=16, HbA1c at entry 6.2% + 0.4) vs physical exercise and diet only (control group B, n=16, HbA1c at entry 6.0% + 0.3). Primary endpoint of this study is the reduction of HbA1c of 0.3 % at 6 month treatment between experimental versus control group. Secondary endpoints include the evaluation of antibodies against insulin (IA), changes in body weight, number of hypoglycaemic events during the treatment period and the evaluation of metabolic control at 6 months after the end of the treatment. HbA1c levels, metabolic parameters and insulin antibodies were measured at baseline, at 3 months up to 6 months followed by 6 months wash out.

Results: Subjects treated with buccal spray insulin achieved a significant reduction of HbA1c compared to the control group ([[unable to display character: ∆]] HbA1c 0’- 6 months -0.3% vs +0.09% p= 0.002). At 6 months after the end of treatment, in group A HbA1c levels raised from 5.8 % + 0.3 to 6.1 + 0.5 resulting in loss of previous achieved improvement of metabolic control and 19% of the treated patients developed TD2 ( vs 6% in the control group). There was no significant difference in body weight and no hypoglycaemic or other adverse events were observed during the study period in both groups. No generation of IA was observed in subjects with IGT treated with buccal spray insulin.

Conclusion: These results indicate that buccal spray insulin is an effective treatment compared to diet + physical exercise in patients with IGT in reducing HbA1c without adverse effects. However the beneficial effects of buccul spray insulin is lost within few months of suspension of treatment. A larger trial is required to demonstrate the long term effects of this buccul spray insulin in preventing TD2 in subjects with IGT.

Supported: Educational grant from Generex Biotechnology

This is the oddest study abstract that I have ever read. If the investigator substitutes Oral-lyn with any other prandial insulin, or another glucose lowering drug, the study will illustrate that beneficial effects of the insulin or drug is lost within a few hours after discontinuation of treatment, never mind six months later.