MINNEAPOLIS, Aug. 18 /PRNewswire/ -- Exsulin Corporation today announced milestones achieved and immediate plans to move forward as a well supported Minnesota-based company dedicated to the development of regeneration therapies for the treatment of diabetes mellitus. Exsulin’s focus is on development of a drug with potential to become a breakthrough therapy for patients suffering from type 1 (T1DM) and type 2 diabetes (T2DM). Phase II human clinical trial data of Exsulin(TM) (INGAP peptide), a peptide drug product aimed at restoring the ability of the pancreas to produce insulin normally in people with diabetes mellitus, have just been published online by Diabetes/Metabolism Research and Reviews.
“Since the landmark discovery of insulin in 1921, only incremental progress has been made in insulin therapy, which remains difficult and hazardous - particularly for people with T1DM,” said G. Alexander Fleming, MD, founder and chairman, Exsulin Corporation. “These study results are very encouraging that Exsulin therapy could restore normal insulin secretion, which would allow insulin dependent T1DM and T2DM patients to achieve normal glucose control while decreasing or ending their dependence on insulin treatment.”
In the T1DM study (SPIRIT 1), Arginine-stimulated C-peptide (AUC0-30) significantly increased from baseline in the 600 mg group (p = 0.0058 versus placebo) while in the T2DM patients (SPIRIT 2) stimulated C-peptide was significantly better preserved in the 600 mg group 30 days after washout (p = 0.031 versus placebo). In T2DM patients, A1C decreased significantly more in the 600 mg group compared to placebo at day 90 (-0.94% versus -0.47%, respectively, p = 0.009) and day 120, 30 days after washout (-0.73% versus -0.24%, respectively, p = 0.013). This was accompanied by significant reductions in mean glucose. Placebo-adjusted A1C trended downward in T1DM patients. Stimulated C-peptide is recommended by experts as the best measure of endogenous insulin secretion and has been acknowledged by FDA to be the primary regulatory efficacy endpoint for T1DM therapies. Increasing evidence underscores that even small amounts of retained insulin secretion helps to prevent complications and serious hypoglycemia in people with T1DM.
“We believe these trial results and further studies will confirm the potential for Exsulin as a breakthrough in diabetes treatment,” said Lisa Jansa, founder and CEO, Exsulin Corporation. “Exsulin will soon begin new Phase II clinical trials at leading diabetes research centers.”
About Exsulin Corporation
Based in Minneapolis, Exsulin Corporation has global rights to a platform that enables research and development of islet cell regeneration approaches for reversing a fundamental cause of type 1 and type 2 diabetes. Exsulin aims to change the future of diabetes care and win significant cost savings for the healthcare system. Exsulin works with leading research labs and clinical investigators in multiple countries to advance understanding and treatment of diabetes. More information can be found at www.exsulin.com.
SOURCE Exsulin Corporation
CONTACT: Leslie Williamson of Weber Shandwick, +1-612-670-7702,
lwilliamson@webershandwick.com, for Exsulin Corporation
Web site: http://www.exsulin.com/
