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exsulin corporation is in Phase II with its lead compound, a novel breakthrough drug aimed at the underlying causes of Type 1 and Type 2 diabetes (T1DM and T2DM). The drug, branded as ExsulinTM, uses a synthetic version of a naturally-occurring peptide that induces regeneration of pancreatic insulin-producing islet cells - which could lead to reversal of the effects of diabetes, and help reduce the use of injected insulin, itself a difficult and dangerous therapy. Though an islet regeneration therapy can benefit both forms of diabetes, a T1DM indication is the priority for Exsulin because of the high unmet clinical need of patients and the virtual absence of other therapies under mid-stage development, particularly for people with established T1DM.  

exsulin has taken advantage of over 80 years of related observations in its pursuit of a frame-breaking regeneration diabetes therapy and $25M of research that has led to consistent animal and human data supporting safety and substantial benefits for both Type 1 and Type 2 diabetes patients.  For the last three years exsulin's founders operated "under-the-radar" to achieve critical milestones in manufacturing, formulation, animal studies, and clinical trial preparations.  The Company is now supporting a Phase II clinical trial at two major diabetes centers - Mayo Clinic (Rochester) and McGill University Hospital Centre (Montreal).  The trial is actively enrolling patients and is the only Phase II clinical trial targeted at regeneration of insulin-producing islets in people with established Type 1 Diabetes.   The Company believes these trials will confirm earlier data showing that Exsulin therapy is an unprecedented medical breakthrough in the diabetes market.  Results are expected within 9 months and upon success will demonstrate a return of natural insulin secretion from a patient's own pancreas.   Any return of a T1DM patient's ability to produce their own insulin would represent a major breakthrough and change the standard of diabetes care providing significant clinical and quality of life benefits.  

exsulin has an experienced founding management team lead by G. Alexander "Zan" Fleming, MD, Chairman and Chief Medical Officer, a recognized authority in diabetes with 12 yrs experience as Head of the Metabolic Group at the FDA responsible for diabetes and other metabolic and endocrine disorders. He is joined by Lisa Jansa, CEO, a long-time business associate and pharma/healthcare executive with experience at Baxter Healthcare, Spectral Diagnostics, and Boston Medical. Together they have put together a broad and expert team who, along with a world class Advisory Board, are leading the way to an FDA Fast Track approved therapy within 5 yrs.

Diabetes is one of the world's most prevalent and fastest growing chronic diseases without cure. It is also a life-threatening condition characterized by a decline in function of pancreatic islets and consequent loss of insulin production. Insulin is a hormone critical to the conversion of sugars and starches into energy. Loss of insulin leads to multiple serious illnesses, making diabetes one of the leading causes of heart attacks, kidney failure, blindness and over 1 million amputations/year. 24M people suffer from diabetes in the US, over 200M are afflicted internationally, and in some regions including the US, China, India and the Middle East incidence is rising to epidemic levels. Costs to the US healthcare system alone are running at a rate of over $170B per year and rising. There has been no fundamental breakthrough in diabetes therapy since the discovery of insulin in 1921, with currently available palliatives that lower blood sugar levels for a limited time being the only treatment available.  Given the scope of the market, the seriousness of the disease, and the lack of a viable cure, the success of a drug that could markedly mitigate and even reverse the effects of insulin loss would be front page news worldwide.

 

///the Company