SOURCE: Generex Biotechnology

September 15, 2006 09:45 ET

Generex Biotechnology to Present Recent Clinical Data at the 42nd Annual Meeting of the European Association for the Study of Diabetes

TORONTO -- (MARKET WIRE) -- September 15, 2006 -- Generex Biotechnology Corporation (NASDAQ: GNBT), the leader in metabolic diseases drug delivery through the inner lining of the mouth, announced today that two poster presentations of recent Company clinical data will be made at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD) (www.easd.org) in Copenhagen, Denmark, September 14 - 17, 2006.

The aims of the EASD are to encourage and support research in the field of diabetes, the rapid diffusion of acquired knowledge, and the facilitation of its application. The EASD currently has more than 5,500 active individual members from over 100 countries.

The first poster, entitled Metformin Gum: An Alternative Method for Delivery of Biguanides, was co-authored by Drs. Jaime Guevara-Aguirre, David Saldarreaga, Marco Guevara-Aguirre, and Jeannette Saavedra of the Institute of Endocrinology IEMYR in Quito, Ecuador, and Dr. Gerald Bernstein, the Company's Vice President -- Medical Affairs.

The poster reports the results of a clinical trial designed to compare pharmacokinetic profiles of metformin (used for the treatment of Type-2 diabetes mellitus in adults and children) administered by both the traditional manner (tablets) and by an alternative presentation (the Generex Metformin Gum product) that can be chewed thereby delivering metformin into the human body by way of the buccal cavity (i.e., the mouth).

The conclusion of the study is that the Generex Metformin Gum displays a pharmacokinetic profile similar to that of the metformin tablets and therefore shows promise as an alternative method of delivering metformin. The Generex Metformin Gum presentation should avoid the significant adverse gastrointestinal side effects often accompanying the use of metformin tablets thereby improving patient compliance. In addition, Generex Metformin Gum is expected to be an ideal companion product for the Company's oral insulin spray product, Generex Oral-lyn™. Generex Oral-lyn is designed to offer a safe, simple, fast, effective, flexible, and familiar alternative to subcutaneous injections of prandial insulin.

The second poster, entitled 3-Month Safety and Efficacy of an Oral Insulin (Generex Oral-lyn™) Administered at Lunchtime in Juvenile Type-1 DM Subjects Maintained on Basal Glargine Insulin and Pre-Breakfast and Pre-Dinner Regular Insulin, was co-authored by Drs. Jaime Guevara-Aguirre, Marco Guevara-Aguirre and Jeannette Saavedra of the Institute of Endocrinology IEMYR in Quito, Ecuador.

The poster presents interim results of a long-term study of 24 adolescents and five young adults with Type-1 diabetes who replaced prandial subcutaneous injections of insulin with split doses of Generex Oral-lyn (i.e. puffs before and after meals). The interim results (three months) of the ongoing study (i.e. parameters of metabolic control) indicate that Generex Oral-lyn can effectively replace prandial subcutaneous injections of regular insulin.

Generex believes that this approach offers a new diabetes treatment paradigm by offering improved efficacy (as Generex Oral-lyn is better at mimicking the healthy body's natural insulin production) and patient compliance (no painful injections) resulting in greater metabolic stability thereby better controlling diabetes and reducing the complications associated with it. Treatment of adolescents with Type-1 DM is challenging and Generex choose to replace the lunchtime dose because it is this dose that is most frequently associated with non-compliance.

The Company believes that Generex Oral-lyn can make a significant contribution to the achievement and maintenance of metabolic stabilization by providing a safe, simple, fast, effective, flexible, and familiar alternative to prandial insulin injections.

As a pain-free and convenient method of insulin delivery that is better at mimicking the healthy body's natural insulin production, Generex Oral-lyn will allow individual patients to "fine tune" and then maintain their metabolism, resulting in an improved quality of life; the increased metabolic stability will provide better control of diabetes and reduce the complications associated with it.

The study is of particular significance in that the participants are juveniles and young adults, a notoriously difficult group to treat successfully due to the prevalence of non-compliance, particularly in respect of prandial insulin injections. Generex Oral-lyn has been approved in Ecuador for the treatment of juveniles with Type-1 or Type-2 diabetes.

About Generex

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™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), 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 Web site 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.

Contact Information

  • Contacts:
    Shayne Gilliatt
    Generex Biotechnology Corporation
    Phone: (800) 391-6755
    or (416) 364-2551

    Andrew Hellman
    CEOcast, Inc.
    Phone: (212) 732-4300

    Dolores Naney
    Rubenstein Public Relations
    Phone: (212) 843-8018
    Email Contact