WORCESTER, Mass., March 11, 2010 (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, announced today that Health Management Resources, Inc. (HMR) has recently conducted two focus groups in Indianapolis for Generex Oral-lyn™. HMR provides educational programs, materials, and services to the healthcare industry. Specializing in diabetes management, HMR has collaborated with medical associations and industry to develop clinical practice guidelines and to facilitate delivery of diabetes-related information and education to healthcare providers and people with diabetes.
The focus groups were conducted with one group consisting of physicians and another consisting of nurse practitioners. The focus groups were designed to determine the perception and opinions of these healthcare practitioners regarding the Generex's buccal insulin spray, Generex Oral-lyn™. The opinions expressed by both groups were very positive regarding the product and the general consensus was that Generex Oral-lyn™ is a suitable alternative prandial insulin product. Participants also expressed interest in the expanded access Treatment IND program in respect of the product, additional information in respect of which can be obtained on the www.ClinicalTrials.gov website.
Generex announced in September 2009 that the USFDA has granted approval for the treatment use of Generex Oral-lyn™ in patients with Type 1 or Type 2 diabetes mellitus under the FDA's expanded access Treatment IND program. Under the expanded access Treatment IND protocol, Generex Oral-lyn™ will be provided to patients with life-threatening or serious Type 1 or Type 2 diabetes mellitus where there is no satisfactory alternative therapy available to treat the condition.
Generex Oral-lyn™ is the Company's proprietary buccal insulin spray product for the treatment of patients with Type 1 or Type 2 diabetes mellitus, impaired glucose tolerance (IGT) or pre-diabetes. The product is presently in a global Phase III protocol clinical trial in patients with Type 1 diabetes mellitus.
"We are pleased with the results of these initial focus groups as we prepare for our initial distribution under the Treatment IND program," said Anna Gluskin, the Company's President & Chief Executive Officer. "We believe that Generex Oral-lyn™ will play an important role in redefining the diabetes treatment paradigm and that these educational forums will provide valuable information to help us gain the confidence of physicians and nurse practitioners who treat diabetes patients on a daily basis."
The FDA's expanded access Treatment IND Program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Generex Oral-lyn™ qualified for the Program after its safety and efficacy was demonstrated over 10 years of development and clinical studies.
To learn more about the availability of Generex Oral-lyn™ under the Program, as per FDA requirements, the Company has provided information pertaining to the Program within the www.ClinicalTrials.gov website. Details include treatment design and participating sites and/or physicians. Please note that the drug will be available only through qualified investigators who are registered in the Program.
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™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which has been launched 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.