June 17, 2003

News Release: Details of Studies Presented At the 2003 American Diabetes Association 63rd Scientific Sessions

Generex Biotechnology Corporation (Nasdaq: GNBT), a leader in the area of buccal drug delivery, today reported the details of data from studies sponsored by the Company and presented at this week's American Diabetes Association conference in New Orleans, Louisiana. The studies further indicate that the Company's proprietary Oralin(TM) insulin formulation has the potential to be used safely and effectively in place of injected insulin to treat patients with Type-1 and Type-2 diabetes. Oralin(TM) is delivered as a fine spray to the buccal (oral) cavity via the Company's RapidMist(TM) device, where the formulation is rapidly absorbed through the buccal mucosal lining. Reproducibility of Oralin(TM) Absorption in Type-1 Diabetics on 3 Different Occasions -- The goal of this proof of concept study was to evaluate the efficacy and the reproducibility of the absorption of the Oralin(TM) spray (10 puffs, no NPH) in Type-1 diabetic patients after a standard meal challenge at breakfast-time on 3 different occasions. In a randomized crossover study, 12 Type-1 diabetic patients received Oralin(TM) spray via the RapidMist(TM) device on 3 different occasions 3 to 7 days apart or s.c. injection (8-9 units) with a 360 calories 'Ensure'liquid meal 15 minutes after each treatment. The onset action of Oralin(TM) was much faster and reached its peak level (Tmax) at 20 minutes when compared to s.c. injection (Tmax = 60 minutes). There were no statically significant differences on 3 different occasions in Oralin(TM) absorption (p<0.857). The rise in serum insulin concentrations in the Oralin(TM) treated group was comparable to s.c. injection (p<0.760). There was no inter and intra-subjects variability observed in the Oralin(TM) treated group.

Comparison of Oral Insulin Spray vs. s.c. Bolus in Patients with Type-1 Diabetics Stabilized on Insulin Pump (I.V. Drip) -- The goal of this study was to evaluate the efficacy of the Oralin(TM) spray (10 puffs, no NPH) in Type-1 diabetic patients stabilized on insulin drip pump after a standard meal challenge at breakfast-time. In an open-label, randomized, crossover study, 11 Type-1 diabetic patients received Oralin(TM) spray via the RapidMist(TM) device or s.c. injection (7-8 units) with a 360 calories 'Ensure'liquid meal 15 minutes after each treatment. Oralin(TM) spray at meal time controlled glucose levels in a comparable manner to s.c. injected insulin. The onset action of Oralin(TM) was much faster and reached its peak level (Tmax) at 15 minutes. The rise in serum insulin concentrations in the Oralin(TM) treated group was significantly higher compared to s.c. injection. Orally absorbed insulin (Oralin(TM)) proved to be effective in controlling meal related glucose excursion in Type-1 diabetics.

Dose Ranging Study of Oralin(TM) in Healthy Subjects -- The goal of this proof of concept study was to evaluate the efficacy and the dose ranging effect of the absorption of the Oralin(TM) spray of 3 different strengths in healthy subjects under fasting condition. In a randomized, crossover, open label study, 14 healthy subjects received Oralin(TM) spray via the RapidMist(TM) device on 3 different doses (75u, 150u, 225u) on 3 occasions 3 to 7 days apart or s.c. injection 0.11 u/kg (7-9 units) under fasting condition to study the linearity of absorption and the dose ranging effect. The onset action of Oralin(TM) was much faster and reached its peak level (Tmax) at 30 minutes when compared to s.c. injection (Tmax = 60 minutes). The absorption of Oralin(TM) was found to be linear and proportionately showed an increase in the serum insulin levels when compared to the fixed dose of insulin injection. The frequency of hypoglycemia increased with the increase in the Oralin(TM)0 dose. The decreases in C-Peptide and glucose levels were also found to be proportional to the doses of Oralin(TM) and its absorption.

Time Action Profile of Oralin(TM) in Comparison with s.c. Injected insulin in Type-1 Diabetic Patients Under Euglycemic Clamp Technique -- This proof of concept study investigated the time-action profile of Oralin(TM) in comparison with s.c. injected insulin in 10 Type-1 diabetics under euglycemic clamp technique (clamp level 120 mg/dl, continuous i.v. insulin infusion 0.1 mU/kg/min). After a stable baseline establishment in a 40 minute period, patients received either 10 puffs of Oralin(TM) bolus or 0.1 u/kg s.c. insulin injection (7-9 u) in a randomized, 2-way crossover study on two separate occasions. The glucose infusion rates were registered for the next 4 hour period. Oralin(TM) showed faster onset of action and the action was evident within the first 10 minutes of the dose administration and reached peak level within 50-70 minutes (Tmax = 50 minutes, p<0.0001) while the s.c. injected insulin on average was slower in action as expected and reached peak levels around 90-100 minutes. Although the peak serum insulin levels of Oralin(TM) were higher in comparison with the s.c. injected insulin, the duration of the action was shorter for the Oralin(TM) treated group (150 minutes for Oralin(TM) vs 230 minutes for s.c. injected insulin). The relative bio effectiveness of Oralin(TM) was approximately 8% vs regular s.c. injected insulin. No drug related adverse events were observed in this study. In summary, Oralin(TM) has faster onset of action when compared to s.c. injected insulin with time to peak (Tmax) resembling that of insulin lispro. These characteristics are well suited for the treatment of diabetes to manage and control meal related glucose levels safely and effectively.

About Generex

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.

SOURCE Generex Biotechnology Corporation

Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or +1-416-364-2551; or Matthew Henderson of CEOcast, Inc., +1-212-732-4300, This email address is being protected from spambots. You need JavaScript enabled to view it., for Generex Biotechnology Corporation (GNBT)

WEBSITE This email address is being protected from spambots. You need JavaScript enabled to view it.