Generex Oral-lyn Phase III Dossier Submitted To Indian Government For Marketing Approval
Phase III Data Demonstrates Effectiveness and Non-inferiority When Compared to Injected Insulin
WORCESTER, Mass. and TORONTO, Jan. 23, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) today announced that it has been advised by its Indian licensee, Shreya Life Sciences Pvt. Ltd., that they have submitted a dossier of the results of the recently completed Phase III trial of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product, to the Indian government seeking approval for marketing and commercial distribution.
The trial, entitled "A 12 Week, Open Label, Parallel Group, Comparative, Multicentric Phase III Study to Assess Efficacy and Safety of Metered Dose Buccal Insulin Spray versus Rapid Insulin, s.c. on Subjects with Type II Diabetes who are inadequately Controlled (i.e. 6.5% < HbA1C < 8.5%) while on Oral Anti-Diabetic Agents", was conducted at 14 sites in India with 209 subjects randomized with a 95% completion rate. The results of the Phase III trial show that Generex Oral-lyn™ is as effective as subcutaneously injected regular insulin and that non-inferiority has been established. Additionally, Generex Oral-lyn™ was shown to be well-tolerated by patients and a preferred alternative to injection.
Shreya has advised Generex that the dossier was submitted in December of 2012 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. Generex has also been advised that Shreya anticipates receiving government approval for the marketing and commercial distribution of the product, known in India as Oral Recosulin™, in the summer of 2013.
The International Diabetes Federation (IDF) estimates there are over 50 million people with diabetes in India. Generex will be working with Shreya as they develop educational and sales and marketing plans for Oral Recosulin™. "This Phase III trial and upcoming approval demonstrate the viability of Generex Oral-lyn™ as an effective alternative to injected insulin in a large and diverse patient population, and is a significant component in our overall Generex Oral-lyn™ clinical development strategy," noted Dr. James Anderson, Generex's Senior Scientific Advisor. Mark Fletcher, President & Chief Executive Officer of Generex, commented: "We are pleased to be working with our partner Shreya as Generex moves forward in the reestablishment of its global Generex Oral-lyn™ and diabetes programs."
"We are most pleased with the results of our Phase III study," commented Ram Shelat, Shreya's CEO. "In anticipation of the DCGI's approval, we have begun working with Generex to facilitate the commercialization of Oral Recosulin™ in India."
These Generex Oral-lyn developments will be reviewed as part of the previously announced Company conference call scheduled for Thursday, January 31, 2013.
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.
Cautionary Note Regarding Forward-Looking
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
Posted: January 2013