WORCESTER, Mass. and TORONTO, Sept. 27, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today provided an update in respect of the previously announced conference call on the Company's proprietary Generex Oral-lyn™ buccal insulin spray program. The call will focus on recent developments, the planned Generex Oral-lyn™ formulation and process improvements, and the go-forward strategy for the expansion of the Generex Diabetes Program, including diagnostics and therapeutics for type 1 and type 2 patients as well as pre-diabetes, and potential therapeutics for reducing the complications of diabetes.
Earlier this year, the Company announced that its Indian licensee, Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in), had completed a local Phase III trial of the buccal insulin product (branded as Oral Recosulin® in India) and submitted the dossier to the Drugs Controller General (India) (DCGI), Central Drugs Standard Control Organization, Director General of Health Services, Ministry of Health and Family Welfare, Government of India.
The trial, conducted at 14 sites in India with 209 patients (with a 95% completion rate), demonstrated the effectiveness and non-inferiority of the product in comparison to injected insulin and that the product was well-tolerated and a preferred alternative to injection.
In conjunction with its review of the dossier, the DCGI recently requested that the submission be augmented by the inclusion of some stability data from previous studies undertaken by Generex. The Company is in the process of collecting and formatting that data and expects to provide it to Shreya within the next two weeks.
As Generex wishes the conference call to be as informative, comprehensive, and up-to-date as possible, management considers it appropriate to schedule the call once the DCGI's review of the dossier is complete. A further announcement with the date and other particulars of the call will be made in due course.
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. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
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," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" 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 or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
SOURCE Generex Biotechnology Corporation