Generex Announces Expansion Plan for the U.S. FDA Expanded Access Treatment IND Program for Generex Oral-lyn(TM) in the United States
WORCESTER, Mass., March 29, 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 it has expanded its plans for its United States Food and Drug Administration (FDA) Expanded Access Treatment IND Program for its flagship product, Generex Oral-lyn™, to include licensed and qualified Nurse Practitioners in the United States.
Nurse Practitioners in a total of 11 states within the United States have the authority to issue prescriptions to patients without medical doctor collaboration.
In September, 2009, the FDA approved the treatment use of Generex Oral-lyn™ under the FDA's Treatment Investigational New Drug (IND).
The FDA's 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. Drugs that are granted approval by the FDA for the Treatment IND program MUST demonstrate the prospect of efficacy through clinical testing.
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 will be open to eligible patients that comply with the inclusion/exclusion criteria of the protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.
The Company continues to work with its key strategic relationships under the Treatment IND Program in the U.S. for Generex Oral-lyn™ including Assured Pharmacy, which will provide Generex Oral-lyn™ dispensary services to physicians and patients in the program. Assured Pharmacy will also undertake the enrollment of family physicians, endocrinologists, and now, nurse practitioners in the program. TS Biopharma, a multi-tiered pharmaceutical development services organization, will continue to assist in mounting a recruitment campaign for the participation in the program consisting of physicians, nurse practitioners and patients. Health Management Resources is also participating in the program recruitment activities.
"We are so pleased to have the opportunity to include nurse practitioners in the FDA's Treatment IND Program in the United States," said Anna Gluskin, the Company's President and Chief Executive Officer. "Nurse practitioners are usually at the front lines of dealing with patients with diabetes and have the skill set to work closely with patients to implement new safe and efficacious tools in the diabetes treatment paradigm."
In order to learn more about the availability of Generex Oral-lyn™ under the 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 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™ 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.
April 07, 2010