WORCESTER, Mass. and TORONTO, June 25, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) announced today that it has been provided with an update on the status of the clinical and regulatory program for Generex Oral-lyn™, the Company's proprietary buccal insulin spray product, in India (where the product is branded as Recosulin). The update has been provided by the Company's Indian licensee, Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in).
Shreya is undertaking a Phase III clinical study of Generex Oral-lyn™ as a condition precedent to the entitlement to undertake commercial distribution of the product in India. To date, 125 patients have completed the study at 14 sites in India. Shreya has advised that clinical trials at all sites will be completed by the end of July, 2012, at which point statistical data analysis of the more than 200 patients will be undertaken. Shreya has indicated that, before the end of August, 2012, it expects to submit completed study data to the Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Shreya hopes to secure final marketing approval from the Indian government before the end of this year.
"The important information and data collected by Shreya in India will give added support to Oral-lyn™, delivered by the Generex proprietary RapidMist™ platform," stated Dr. James H. Anderson, Jr., MD, FFPM, FACE, Generex' Senior Scientific Advisor. "In conjunction with the scientific data presented at last week's annual meeting of the Generex stockholders, which is available on the Generex website, we will have additional clinical trial evidence of the efficacy of Oral-lyn™ in providing metabolic control to patients along all stages of the continuum of diabetes from impaired glucose tolerance to overt diabetes mellitus. We are committed to providing the best possible formulations of Oral-lyn™ to patients globally, as announced at the recent stockholders' meeting, with our program to increase the convenience, compliance, and safety for patients by producing a more concentrated Oral-lyn™ formulation that would allow dosing in the average patient to be reduced to fewer sprays."
Dr. Anderson continued: "Additional short clinical studies will be designed to demonstrate the potential for Oral-lyn™'s unique pharmacokinetic profile to achieve metabolic results that are not possiblewith sub-cutaneously injected insulins, even with the rapid acting insulin analogs. These studies will allow our marketing partners to more easily obtain reimbursement over injected insulin, and help insure a more rapid uptake of use by patients and the medical community."
"The new Generex Team is committed to the successful development and commercialization of Oral-lyn™," commented Dr. David Brusegard, PhD, Chief Operating Officer of Generex, "and will deploy a strong scientific and clinical strategy to accomplish that for the benefit of patients worldwide."
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 technology 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.