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Retour au sujet GENEREX BIOTECHNOLOGY CORP

GENEREX BIOTECH : Bon article pour GNBT....

09 juin 200917:07

Generex Presented Positive Study Data At the American Diabetes Association Scientific Sessions



WORCESTER, Mass., June 9, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that data in respect of two of its products was presented at the American Diabetes Association's (ADA's) 69th Annual Scientific Sessions held in New OrleansJune 5 - 9, 2009.

As part of the session on New Concepts on Insulin Delivery Applications, independent clinician Professor Paolo Pozzilli, Head of the Department of Diabetes and Endocrinology at University Campus Bio-Medico, Rome, Italy, made a podium presentation of his abstract entitled Buccal Spray Insulin for the Management of Post-Prandial Hyperglycaemia in Subjects with Impaired Glucose Tolerance.

Postprandial hyperglycaemia (PPHG) occurs as the consequence of a reduced early insulin response after a meal and has been linked with an increased risk of cardiovascular events and raised mortality risk. Subjects with PPHG often present with dyslipidaemia, hypertension, abdominal obesity, microalbuminuria, endothelial dysfunction and markers of inflammation. The objective of this phase II study was to investigate the safety and efficacy of treatment with Generex Oral-lyn(tm), the Company's proprietary oral insulin spray product, on post-prandial plasma glucose excursions and insulin levels in subjects with impaired glucose tolerance (IGT). 15 subjects with IGT were included in the study. Subjects were randomized to take 4, 6 or 12 Generex Oral-lyn(tm) puffs, split in two doses each, before and 30 minutes after a standard oral glucose tolerance test (OGTT). Glucose excursions and insulin levels were measured at baseline and at 30, 60, 90, 120 and 180 minutes. There were no significant differences in glucose levels during OGTT with 4 or 6 Generex Oral-lyn(tm) doses compared to baseline OGTT. Treatment with 12 doses was followed by a significant 31.2% decrease in mean plasma glucose at two hours and a 28.4% decrease at three hours. Considering all time points of OGTT, there was a mean reduction of 16.5% in plasma glucose levels. There was a trend for increased insulin levels at all measurements reaching statistical significance at 30 minutes. No adverse events were observed during the study period. The study demonstrates that treatment with Generex Oral-lyn(tm) is a simple and valuable therapy for PPHG in subjects with IGT.

"With the explosion in the number of people with diabetes and pre-diabetes, now estimated to be 43% of the United States population over the age of 20, effective intervention will be required to address the significant attendant cardiovascular risks in the coming years," said Dr. Gerald Bernstein, the Company's Vice-President for Medical Affairs. "These study results suggest that Generex Oral-lyn(tm) could play a valuable role in the treatment regimen."

In addition, an abstract entitled A Novel Tool to Control Hypoglycaemia and Improve HbA1c in Very Young Children with Type 1 Diabetes, which featured Glucose RapidSpray(tm), the Company's proprietary glucose buccal spray product, was a poster presentation at the 2009 ADA scientific sessions.

Hypoglycaemia continues to be a complex condition to tackle, especially in children because of difficulties in administering glucose as well as child compliance. The aim of this study was to evaluate the effect of administering small amounts of glucose through Glucose RapidSpray(tm) (GRS) during first signs of hypoglycaemia in children affected by type 1 diabetes (T1D) to evaluate if such treatment was able to improve the metabolic control over a period of 9 months. GRS consists of a 19 ml bottle containing 10 g glucose solution with the addition of artificial flavors and excipients to facilitate buccal absorption, delivering glucose by spray in quantities as small as 0.5 grams. The trial was comprised of 27 T1D children up to 5 years of age. They were randomly allocated into two groups: A) GRS (10-20 puffs of GRS, 0.5 g to 1 g glucose) depending on hypoglycaemic symptoms; and B) traditional treatment of hypoglycaemia episodes (sugar, fruit juice, etc). The following parameters were evaluated at entry into the trial, at three months, at six months, and at the end of the study: HbA1c, number of hypoglycaemic episodes, compliance to treatment, and quality of life of children and parents. After three months, both groups showed a significant improvement in HbA1c with no differences between groups which further improved at 6 months, and at the end of the study. There was a statistically significant difference in the improvement of the HbA1c in the GRS treated group versus the control group. Finally, children in group A showed a tendency for less severe hypoglycaemic episodes during the day compared to group B in the observational period. A more acceptable and practical tool to manage hypoglycaemia, especially in toddlers, represents a very relevant therapeutic issue. GRS is able not only to reduce the risk of hypoglycaemia but to improve the overall metabolic control as shown by a reduction of HbA1c.

"The great value of GRS in this particular population, in addition to addressing hypoglycaemia, is that it is designed to allow parents to administer glucose in a specific and controlled fashion thereby providing considerable security and empowerment," observed Dr. Bernstein.

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization 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 India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at http://www.generex.com.

The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives in respect of 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 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. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

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