WORCESTER, Mass. and TORONTO, July 10, 2013 /PRNewswire/ — Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced the results of a Phase 3 clinical trial, conducted by its Indian licensee, Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in), of Generex Oral-lyn™, the Company’s proprietary buccal insulin spray product, in preparation for the approval for marketing and commercial distribution of the product in India, to be trademarked there as Oral Recosulin™.
The trial, entitled “A 12 Week, Open Label, Parallel Group, Comparative, Multi-centric 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% less than or equal to HbA1C less than or equal to 8.5%) while on Oral Anti-Diabetic Agents”, was conducted at 14 sites in India. Type 2 patients between 18 and 75 years of age with at least one year of use of oral anti-diabetes medications were eligible to participate. Two hundred and nine (209) subjects were randomized to receive either Generex Oral-lyn™ buccal insulin spray or injected human regular insulin before each major meal as an add-on to the patient’s current oral hypoglycemic agent. Dosing was periodically adjusted based on prior fasting blood glucose values. Each subject was instructed in an ADA/IDF (American Diabetes Association/International Diabetes Federation) guidelines dietary plan. One hundred ninety eight subjects (95%) completed the trial.
The hemoglobin A1c (HbA1c) was measured at baseline, 6 weeks and 12 weeks with the following results,
Time Period Oral-lyn™ Buccal Insulin Spray N=116 Regular Insulin Injection N=82
Baseline 7.44 +/- 1.34 7.47 +/- 1.40
6 weeks 6.96 +/- 1.83 7.42 +/- 1.23
12 weeks 6.99 +/- 1.58 7.24 +/- 0.96
Generex Oral-lyn™ significantly lowered the HbA1c at 6 weeks and 12 weeks compared to baseline (p less than 0.05) while injected human regular insulin did not significantly lower the HbA1c until 12 weeks. Generex Oral-lyn™ resulted in a significantly lower HbA1c at 6 weeks than did injected regular insulin (p less than 0.05). At 12 weeks the HbA1c for both groups were statistically comparable.
The results of this Phase III trial show that Generex Oral-lyn™ more rapidly reduced hemoglobin A1c and was as effective as subcutaneously injected regular insulin at the trial’s conclusion establishing non-inferiority. Adverse events were rare and comparable between groups. Generex Oral-lyn™ was shown to be easily used and well-tolerated by patients, and over two thirds of patients preferred Generex Oral-lyn™ 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™, by the end of this year.
The International Diabetes Federation currently estimates there are over 50 million people with diabetes in India. Generex will be working with Shreya as it develops its educational and sales and marketing plans for Oral Recosulin™. “This Phase III trial and upcoming approval demonstrate the viability of Generex Oral-lyn™ as a safe and 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.
Ram Shelat, Shreya’s CEO, commented, “We are most pleased with the results of our Phase III study. In anticipation of the DCGI’s approval, we have begun working with Generex to facilitate the commercialization of Oral Recosulin™ in India.” Mark Fletcher, President & Chief Executive Officer of Generex, noted, “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.”
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