news....
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(TM) buccal insulin spray program. The call will focus on recent developments, the planned Generex Oral-lyn(TM) 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(R) 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.
