Generex Biotechnology Reports Preliminary Outcomes and Trends From Ongoing Phase III Clinical Trial of Generex Oral-lyn(TM)
Findings Based on In-Process Data for Subjects That Completed the 6-Month Treatment Phase of the Study Demonstrate Several Favorable Comparisons to Injectable Insulin
WORCESTER, Mass., Jun 7, 2010 (GlobeNewswire via COMTEX News Network) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today reported preliminary outcomes and trends from the ongoing Phase III pivotal study of Generex Oral-lyn(TM), the Company's proprietary oral insulin spray product.
Observations were made regarding insulin antibody levels, weight gain, body mass index, and hypoglycemic events. Information on reported trends has been collected from in-process, non-finalized data. With over 400 subjects now enrolled in the Phase III global clinical trial of Generex Oral-lyn(TM), a brief look at open data from the Electronic Data Capturing System (EDC) reveals the following for subjects that completed the 6-month treatment phase of the study:
Insulin resistance has not been observed for subjects using Generex Oral-lyn(TM). Subjects using Generex Oral-lyn(TM) demonstrated no weight gain, on average, and an actual decrease in Body Mass Index (BMI). This compares favorably to subjects using injectable insulin that have, on average, gained weight and experienced an increase in BMI. When comparing hypoglycemic events, subjects using Generex Oral-lyn(TM) were observed to have a better Adverse Event profit than subjects using injectable insulin. Furthermore, there have been fewer severe hypoglycemic events for those using Generex Oral-lyn(TM) than those using injectable insulin.
"We are very pleased that these key characteristics often monitored throughout insulin treatments are trending favorably," stated Anna Gluskin, Generex's President & Chief Executive Officer. "As weight gain and hypoglycemic events are often negative side effects of injectable insulin, it is extremely encouraging that regular administration of Generex Oral-lyn(TM) has been observed to result in a decrease in BMI and fewer severe hypoglycemic events."
These reported trends and outcomes are preliminary only. Once approximately 450 subjects are enrolled in the study, a formal interim analysis of the collected data is planned.
While the Phase III global study continues, Generex Oral-lyn(TM) remains available under the Treatment IND program in the United States. In September 2009, the FDA granted approval to Generex to proceed with the treatment use of Generex Oral-lyn(TM) under the Treatment IND program, pursuant to which the product can be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company's Phase III study of the product. The Treatment IND program is open to eligible patients in the USA who comply with the selection criteria of the treatment protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for the program.
To learn more about the availability of Generex Oral-lyn(TM) under the Treatment IND program, the Company has provided information within the www.ClinicalTrials.gov website on the program design and contact information on all participating sites and/or physicians.
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, buccal insulin (Generex Oral-lyn(TM)), which has been approved in India, Lebanon, Algeria, 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. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
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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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SOURCE: Generex Biotechnology Corp.
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