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Phase Two Clinical Trials of Trans-buccal Insulin to Begin in August


Press Release Date: July 8, 2014


With ESNano having already demonstrated to required standards in Phase one clinical trial that trans-buccal insulin formulation is by its very design both safe and offering a high rate of barrier absorption efficacy, Phase two testing of this exciting and groundbreaking delivery mechanism is cleared to proceed in August 2014.


The true scope of the revolution in the lives of sufferers of Diabetic conditions, which is now on offer with ESNano’s development of Insulin delivery by Trans-Buccal means, may at first glance be easily overlooked by any layman. What it means however to both doctors and patients alike is the chance to part company with a lifelong regime of insulin injections, saving discomfort and inconvenience for the million living with diabetic conditions throughout the world.


The promise of utilizing the previously unexplored delivery mechanism for the delivery of insulin regimes was noted early on by ESNano and with the successful completion of Phase One clinical trials in May, the process demonstrating a high rate of barrier absorption efficacy and subject safety, failing to occasion any adverse pharmacological events or discomfort in any test subjects over the course of the four month trial schedule, the merits of this approach were clear to all parties.


Phase Two Clinical trials will see ESNano’s Trans-Buccal delivery system tested across an even larger sampling group comprising a total of 140 test subjects with three categories to be represented, Type-1 and 2 conditions and a control group with external peer review to be administered by the University of Chicago’s Medical faculty. The testing regime is scheduled to occur over a period of six months with data review and result compilation to be completed within three months of the trials completion date.


ESNano Technolgy Development Ltd’s Chief Scientific Officer, Prof. David Radcliff described the company’s feelings on the Trans-Buccal Insulin project justly “we have placed a high degree of our corporate and individual focus as well as time into this project as we have from the beginning seen the great improvement in the quality of life that this mechanism offers for so many of those that suffer with diabetes around the world and to this end we look forward to taking this process through the demanding criteria of its stage two trials.”


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