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Generex finalizes protocol for Metformin chewing gum

Generex Biotechnology has finalized the protocol for MetcontrolT, the company's proprietary Metformin chewing gum product, and will be proceeding with applications to regulatory agencies for approval of the protocol for a clinical study.

The protocol is an open-label crossover study comparing Generex’s Metformin chewing gum and immediate release tablets in healthy volunteers. The company anticipates that approximately 75 – 100 patients will participate in the study.

Metformin is a generic drug used to regulate blood glucose levels by reducing liver glucose production and improving insulin sensitivity by the cells. The delivery of Metformin in a good tasting chewing gum format may make the drug more acceptable to these patients and may increase compliance with the therapy.

Anna Gluskin, president and CEO of Generex, said: “The goal of the Metformin gum development is to provide an alternative method of drug delivery that will improve both safety profiles and therapeutic compliance.”