Generex Biotechnology Presents Oral-lyn(TM) Clinical Trial Results Company presents at the American Diabetes Association 65th Scientific Sessions
TORONTO, Generex Biotechnology Corporation (Nasdaq: GNBT - News), a leader in the area of buccal drug delivery, today announced clinical trial results in respect of Oral-lyn(TM), the Company's proprietary oral insulin buccal spray formulation, presented at the 65th Annual Meeting & Scientific Sessions of the American Diabetes Association held June 10 - 14, 2005 in San Diego. Generex clinician Dr. Jaime Guevara-Aguirre presented a poster in the Clinical Therapeutics/New Technology -- Insulin Delivery Systems category titled "A Series of Open-Label Studies Comparing Various Formulations of Oral-lyn(TM) Propellant Spray in Patients with Type- 1 Diabetes Mellitus" (co-authored with M. Guevara and J. Saavedra). During the normal drug development process and besides evaluating Oral-lyn(TM) against its active comparator, it was necessary to test preparations with different insulin concentrations or different ratios of the excipients included in the Oral-lyn(TM) formulation. In Dr. Guevara's study, the glucodyanmic (GD) profiles induced by single pre-prandial versus pre- and post-prandial split doses of Oral-lyn(TM) were compared to the GD profile of Humulin-R in a 3-day (4 hours per day) open-label study performed in patients with Type-1 diabetes. In a second experiment, Dr. Guevara tested the relative efficacy of various Oral-lyn(TM) preparations in a series of similar 4-hour open label studies performed in the same individuals with a view to determining the most appropriate Oral-lyn(TM) preparation for longer term trials. In the first experiment, Oral-lyn(TM), in either a single pre- prandial dose or in a split-dose fashion, was administered to 6 patients with Type-1 diabetes. The corresponding GD profiles were compared to the GD profiles induced by the administration of the active comparator (subcutaneous injection of Humlin-R) 30 minutes prior to the same test meal. The study determined that a pre- and post-prandial split-dose of Oral-lyn(TM) was better than a pre- prandial single dose and comparable to the GD profile induced by Humulin-R. The second experiment included a series of open-label studies at which the same 6 patients with Type-1 diabetes received, in different days, single does of each preparation of Oral-lyn(TM) in a split-dose regimen with 5 puffs before and 5 puffs after the test meal. After evaluation of the GD profiles of the various preparations, Dr. Guevara was able to identify the preparation that exhibited the best GD profile for use in longer term trials. In addition, Generex clinician Professor Itamar Raz published a paper in the Abstract Book for the 65th Annual Scientific Sessions titled "Addition of Oral-lyn(TM) at Mealtimes in Subjects with Type- 2 Diabetes Maintained on Glargine + Meformin -- A Comparison with Placebo" (co-authored with A. Dubinsky, M. Kidron and J. Wainstein). The purpose of the Professor Raz study was to determine the metabolic effect of Oral-lyn(TM) at mealtime on a long-term basis (12 weeks) in patients with Type-2 diabetes maintained on once-a-day subcutaneous Glargine insulin injection therapy at bedtime and Metformin. The primary hypothesis was that Oral-lyn(TM) can be used safely at mealtimes and will improve 7 point glucose profiles, fructosamine and the baseline HbA1c levels 12 weeks after treatment. This was a randomized, double-blind, long-term (12 weeks) study in 26 patients with Type-2 diabetes (male or female) with poorly controlled blood glucose maintained on once a day s.c. Glargine and Metformin. After the initial screening visit, subjects maintained their regular treatment for two weeks as a run-in period. Following the training of the Oral-lyn(TM) device operation and dosing schedules, they were divided into two groups. One group had 7 puffs of Oral-lyn(TM) TID, and the other group had 7 puffs of placebo TID. Both groups took the puffs 10 minutes before mealtime in addition to their regular treatment. In cases where self-glucose values were above 12mmol/L before any meal or before bedtime, an additional 7 puffs were added. Each subject had routine blood chemistry and HbA1c as well as fructosamine levels at the beginning of the study and at the end of every month during the study period. Beginning with the initial screening visit, each subject had to monitor his/her blood glucose at least three times a day and once a week for a 7-point profile. The interim results, after 8 weeks of treatment, showed no change in fasting glucose while in post-prandial glucose there was a 15.4% reduction in the Oral-lyn(TM) group versus 3.9% elevation in the placebo group. Furthermore, the study found a reduction of fructosamine in the Oral-lyn(TM) group of 6.4% versus 3.6% in the placebo group and for HbA1c there was a 6.6% reduction in the Oral- lyn(TM) group versus 3.4% in the placebo group. The effective post- prandial trend can be seen clearly, although the results are not statistically significant. This may be partially due to the short time period and small sample size of the study. The study concluded that in patients with Type-2 diabetes maintained on Glargine and Metformin, Oral-lyn(TM) was especially effective in controlling post-prandial glucose excursions. About Generex Generex (http://www.generex.com) 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 Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), is in late stage clinical trials around the world. 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," "f orecasts," "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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. 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