WORCESTER, Mass., April 13, 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, today announced that John Muir Physician Network Clinical Research Center has agreed to participate in the United States Food and Drug Administration (FDA) Expanded Access Treatment Investigational New Drug (IND) Program for the Company's flagship product, Generex Oral-lyn™, a proprietary buccal insulin spray product. In September 2009, the FDA approved the treatment use of Generex Oral-lyn™ under the FDA's Treatment IND Program.
John Muir Physician Network Clinical Research Center is a top-rated and prestigious clinical research site. John Muir Physician Network Clinical Research Center is part of the John Muir Physician Network, which is comprised of John Muir Medical Group, a group of nearly 800 providers, and is a subsidiary of John Muir Health, a recognized leader in providing quality medical care in the San Francisco/Bay Area. John Muir Physician Network Clinical Research Center will be the first site in the State of California to participate in the Treatment IND.
John Muir Physician Network Clinical Research Center provides rapid enrollment, high data integrity, as well as compassionate and quality care to their research subjects. It has extensive primary research experience in diabetes mellitus and its complications and other endocrine metabolic disorders such as obesity.
"We are very pleased by the participation of John Muir Physician Network Clinical Research Center," says Anna Gluskin, Generex's President and Chief Executive Officer. "We anticipate that a concentrated effort for the Treatment IND Program within centers that have an established network of patients with diabetes will serve as a good base from which the program can expand within the United States."
Under the Expanded Access Treatment IND program, Generex Oral-lyn™ will 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 ongoing global Phase III pivotal clinical trial.
This Treatment IND is open to patients 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 this treatment use program.
To learn more about the availability of Generex Oral-lyn™ under the Treatment IND program, as per FDA requirements, the Company has provided information within the www.ClinicalTrials.gov website. Details include program design and participating sites and/or investigators.
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.