Generex Biotechnology Corp. (Nasdaq: GNBT) is a leader in drug delivery for metabolic diseases through the inner lining of the mouth. The company has developed a proprietary Metformin chewing gum product, MetControl. Today, the company announced it produced clinical samples of Metcontrol, manufactured under GMP conditions, to be used in upcoming trials.

“We are pleased to have completed this significant milestone with respect to our medicinal chewing gum product,” Rose Perri, the company’s chief operating officer stated in the press release. “This represents the expansion of the company’s proprietary drug delivery platform as it utilizes the core science behind the company’s RapidMist delivery system in another form and application.”

The results will allow the company to continue additional R&D initiatives and to consider regulatory agency registration applications. The upcoming study will involve approximately 36 patients and will allow the company to conduct an open-label crossover study to compare MetControl and immediate release tablets in healthy volunteers.

Metformin allows for effective use of insulin produced by the body to reduce the amount of liver glucose production. Metformin is the “backbone” of most treatments for Type 2 diabetes mellitus. Metformin addresses the issues, such as large pill size and bitter taste, of traditional prescription drugs for Type 2 diabetes. Metformin will be administered in a good-tasting chewing gum and may thereby increase compliance with the treatment.

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