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Phase II Begins for a New Islet Regeneration Treatment

Sep 13, 2009

Exsulin Corporation announces next hase II trial of novel islet regeneration treatment in Type 1 diabetes. Leading diabetes research centers collaborate on new trial designed to further evaluate regeneration treatment for people with Type 1 diabetes.

Exsulin Corporation announces 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. 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 patients treated with Exsulin.

“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.”

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.