MINNEAPOLIS, Sept. 10 Exsulin Corporation today announced the start of a phase II human clinical trial of Exsulin(TM), a peptide drug product aimed at restoring insulin production in people with diabetes mellitus. The randomized, controlled 12-week trial in patients with established Type 1 diabetes (T1DM) will be co-led by Mayo Clinic in Rochester, Minn., and McGill University Health Centre in Montreal, Canada. First results are expected to be available in Q2 2010. The design of the study is based on previous trials which showed improvement in insulin secretion and glucose control in both Type 1 and Type 2 diabetes (T2DM) patients treated with Exsulin.
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Diabetes is a life-threatening condition affecting nearly 24 million people in the United States, and more than 200 million worldwide. It remains one of medicine's most significant and costly chronic diseases, and its prevalence is expected to grow due to the global obesity epidemic and the aging of the population. T1DM develops when the body's immune system destroys pancreatic beta cells that make insulin, the key hormone responsible for controlling blood sugar levels. All people with T1DM require insulin therapy to survive. People with T2DM have insufficient insulin secretion and uptake, and often require insulin therapy as their disease progresses. Poorly controlled diabetes can lead to serious complications, including blindness, kidney failure and death.
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"Exsulin is a hormone that is being studied for its potential ability to regenerate islets - and possibly restore insulin production -- in the pancreas," said G. Alexander Fleming, MD, founder and chairman, Exsulin Corporation. "We look forward to the results of this important study, which will build on previous findings and further characterize the effects of Exsulin on insulin production and glucose control."
"This phase II trial represents a critical milestone in demonstrating the potential of Exsulin as a novel approach to diabetes treatment," said Lisa Jansa, founder and CEO, Exsulin Corporation. "Exsulin is the only islet regeneration hormone now in clinical development for people with established T1DM. If this trial confirms previous data, we are confident we can advance Exsulin to phase III trials, with the ultimate goal of bringing an innovative new treatment to the millions of patients living with diabetes."
About the Trial Sites
Exsulin's phase II trial will be undertaken by a cross border effort led by diabetes research centers at Mayo Clinic in Rochester, Minnesota, and the McGill University Health Centre in Montreal, Canada. Teams in both locations will begin recruitment of T1DM patients with established disease (greater than two years since diagnosis) for enrollment in the trial. Selection of patients will require an A1C of 7.5 or less. McGill University has a long history in diabetes care and research. McGill is the home of the JDRF Centre for Beta Cell Regeneration, which has made many contributions to the understanding of the human pancreatic islet.
About Exsulin Corporation
Based in Minneapolis, Exsulin Corporation has global rights to and pioneered the development of an experimental approach for the treatment of Type 1 and Type 2 diabetes with the goal of affecting the future of diabetes care and providing significant cost savings within the healthcare system. Exsulin has worked with leading research labs in multiple countries to develop the technology that has led to the current trial. More information can be found at www.exsulin.com.
SOURCE Exsulin Corporation
