Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, had a meeting with the Veterinary Drugs Directorate (VDD) of Health Canada on 14 July in Ottawa, Canada. The meeting was a pre New Drug Submission (NDS) meeting for the purpose of outlining the company's proposed development plan for the veterinary application of Generex Oral-lyn, the company's proprietary oral insulin spray product, with a view to proceeding with the filing of an NDS. As a result of this meeting, the company plans to prepare an IND package for submission to the VDD before the end of this year.
Anna Gluskin, the company's president & chief executive officer, commented, "We are delighted to have made the necessary progress to further establish our plans for our flagship product, Generex Oral-lyn, in the veterinary field. This step is very important in that it paves the way for improved treatment for companion dogs (and later cats) suffering from diabetes. Generex Oral-lyn will provide a more user-friendly option to pet owners and encourage compliance."
To date, the company has conducted a two-year safety study on dogs as well as drafted a preliminary clinical design in order to meet some of the regulatory requirements for the IND application.
Generex is engaged in the research, development and commercialization of drug delivery systems and technologies.