Generex Biotechnology Corporation, announced the results of a phase III clinical trial, conducted by its Indian licensee, Shreya Life Sciences Pvt. Ltd., 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 per cent less than or equal to HbA1C less than or equal to 8.5 per cent) 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 per cent) completed the trial.

Generex Oral-lyn significantly lowered the HbA1c at six 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 six 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 haemoglobin 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 Organisation, 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 & CEO 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 programmes."

Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies.