Echo Therapeutics Initiates Clinical Trial of its Symphony tCGM System in Patients with Type 1 and Type 2 Diabetes
PHILADELPHIA, Oct. 13, 2011 /PRNewswire/ – Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the SymphonyÃ‚® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the PreludeÃ‚® SkinPrep System for transdermal drug delivery, today announced that it is initiating a clinical study of its Symphony tCGM System in patients with Type 1 and Type 2 diabetes. The company expects to complete and announce the results of the study in the fourth quarter, and plans to subsequently begin a separate study in critical care patients.
“Building on the positive momentum generated by the results of our last clinical study of the Symphony System, we are excited to have started our next study in the important diabetes home use market,” said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. “This trial is an important step not only for our glucose monitoring technology and the company, but also for the diabetes community. We believe that Symphony represents an opportunity to better monitor glucose levels in people with diabetes and we look forward to confirming this in the trial.”
Echo plans to enroll in the clinical study up to twenty-five (25) patients with either Type 1 or Type 2 diabetes and to compare data obtained from its Symphony tCGM System with both the YSI 2300 STAT Plus Glucose Analyzer and a commercially available professional-use glucometer. The study is expected to collect more than 2400 data pairs to be used in the analyses by taking frequent reference glucose measurements for 24 hours. The study data will be blinded to study subjects and study personnel. A comparison of the data relative to the reference blood glucose values will be used to assess the accuracy of Symphony.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The Centers for Disease Control and Prevention predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. Worldwide, the number of adults with diabetes has doubled over the last three decades to nearly 350 million and increased nearly three-fold in the U.S., according to a study published in the British journal Lancet. The total cost of diagnosed diabetes in the U.S. was estimated at $174 billion in 2007.
About Continuous Glucose Monitoring (CGM)
Continuous glucose monitoring has the potential to help plan diabetes treatment, guide day-to-day choices about diet, exercise and insulin use, and avoid unwanted low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) events and the complications that they can cause. Blood glucose levels are affected by many factors such as the carbohydrate and fat content of food, exercise, stress, illness, and variability in insulin absorption among others; therefore, it is often challenging for diabetes patients to avoid frequent and unpredictable excursions above or below normal glucose levels. Patients are often unaware that their glucose levels are either too high or too low, resulting in their inability to control their glucose levels and prevent the complications associated with unwanted glucose excursions.
About Echo Therapeutics
Echo Therapeutics is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in hospital critical care units. Echo is also developing its needle-free Prelude SkinPrep System as a platform technology for enhanced skin permeation for delivery of topical pharmaceuticals.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s and its partners’ ongoing studies, including: the safety and efficacy of Echo’s Symphony tCGM and Prelude SkinPrep Systems; the failure of future development and preliminary marketing efforts related to Echo’s Symphony tCGM and Prelude SkinPrep Systems; Echo’s ability to secure additional commercial partnering arrangements; risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell diagnostic and transdermal drug delivery products based on its skin permeation platform technologies, including the Symphony tCGM and Prelude SkinPrep Systems; the availability of substantial additional funding to support its research, development and product commercialization activities; and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony tCGM and Prelude SkinPrep Systems. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2010, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
SOURCE Echo Therapeutics, Inc.