Generex Biotechnology Corporation GNBT · News · Profile , the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced new clinical data from a trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product.
The study compared the effects of two forms of prandial (mealtime) insulin in patients with Type-1 diabetes mellitus maintained on basal isophane insulin (NPH): Generex Oral-lyn versus pre-prandial subcutaneous injections of regular bolus insulin.
NPH is an intermediate acting insulin that peaks between 6-8 hours and may last as long as 8-10 hours or more. It has in recent years been replaced in some parts of the world by glargine, a basal insulin analogue. Regular insulin is a bolus or mealtime insulin taken a half hour before eating to combat post-meal blood glucose surges. Generex Oral-lyn is regular bolus insulin delivered by spray into the mouth (using the Company's proprietary RapidMist(TM) device) and is designed to replace mealtime insulin injections. NPH is the only longer acting insulin used in many parts of the world. The pharmacokinetics of Generex Oral-lyn (duration 2 hours) make it complementary to NPH, both functionally and economically. Unlike "inhaled" insulin products, Generex Oral-lyn does not enter the lungs; rather, the insulin is absorbed by the inner lining of the mouth.
In this study, 11 subjects in the control group received twice daily injections of NPH and three pre-meal injections of regular insulin. 14 subjects in the treatment group received twice daily injections of NPH and three split-dose applications of Generex Oral-lyn (i.e. RapidMist puffs of Generex Oral-lyn before and after meals). The comparison phase, following a stabilization phase, lasted 99 days with fructosamine and glycated hemoglobin (HbA1c) determined, on average, every 14 days.
The study demonstrated that both Generex Oral-lyn and mealtime injections of regular insulin achieved near normalization of metabolic control parameters as reflected by continuous improvement in fructosamine and HbA1c concentrations. In fact, a straightforward comparison of HbA1c during the comparison phase showed a superior effect for Generex Oral-lyn. By providing a safe, simple, fast, flexible, familiar, and effective alternative to mealtime insulin injections, Generex Oral-lyn is designed to improve patient compliance which promotes metabolic stability which in turn delays the onset and reduces the severity of the complications associated with diabetes.
This study provides the format for the Company's pivotal late-stage, long-term trial of Generex Oral-lyn in 300 patients which will begin early in 2007.
Generex 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 (Generex Oral-lyn(TM)), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. For more information, visit the Generex website at www.generex.com.
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," "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 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. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Posts: 252 | From: WestCoast | Registered: Oct 2006
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wow gnbt one of the first stocks i ever bought over 5 years ago...anyway this was the product that hooked a lot of investors purely because no1 likes to poke themselves with needles i dont know if it was the same name i forget...but still MORE time..but yeah i agree with ABEX youll have time to buy under 2.00 its a very risky play and i dont suggest it personally..
Posts: 3086 | From: miami | Registered: Nov 2005
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