Charles H. Best and Frederick Banting co-discovered insulin in 1921.

Perle Bioscience continues their efforts to help those living with diabetes.

Information for Healthcare Professionals

Type 1 diabetes is a serious, chronic disease affecting over 3 million children and adults in the United States alone.  Each day 80 children and adults are diagnosed with type 1 diabetes in the US.1  Type 1 diabetes affects every organ system of the body. The annual cost of medical care for young people with diabetes is six times higher than medical care for children and teens without the disease, according to the U.S. Centers for Disease Control and Prevention study.2  The cost of treating type 1 diabetes is estimated at $38,000 each year in the US for patients on insulin pumps.3  Type 1 diabetes accounts for $14.9 Billion in costs per year in the US.4,5

One of the greatest new insights in the field of type 1 diabetes is the understanding that unlike the success seen in type 1 mouse models treated with a variety of immune therapies, in man, beta cell regeneration does not occur.  Thus type 1 diabetes in man is now considered not only a disease of autoimmunity, but also a lack of beta cell regeneration, even in the presence of immune therapy. 6

The necessity of combination therapy with a biologic response modifier and an islet neogenesis agent has evolved from the past 3 decades of type 1 diabetes research, in which two lines of research have dominated the field:  1) trials to alter the immunological response against beta cells, and 2) trials developing and replacing beta cells, including islet cell transplantation.  While immunosuppressants have been shown in some studies to prolong the maintenance of beta cells, it does not halt or reverse beta cell failure.  While beta cell replacement can result in insulin production, the effects are not long lasting.

Numerous different immunological based therapies have shown some ability to preserve remaining beta cell function, but none completely halted or reversed beta cell failure.  More than 50 trials have used a number of therapies among new onset type 1 patients including: the heat shock protein 60,  Diapep 277, Bacille Calmette–Guérin (BCG vaccine), mycophenolate mofetil, daclizumab, rituximab (anti CD20), anti CD3 antibodies including hOKT3 gamma1 (Ala-Ala), the monoclonal antibody TRX4 (ChAglyCD3), CTLA4-Ig (abatacept), campath-1H, the anti-CD52 antibody, a polyclonal anti-T-lymphocyte globulin (ATG), the GAD antibody vaccine based on the 65 kDa isoform of the recombinant human glutamic acid decarboxylase protein (rhGAD65), diazoxide, Alpha-1 Antitrypsin and others.

Therefore, new therapies that treat both autoimmunity and aid with islet neogenesis may hold the key to future approaches for this significant public health concern with a large and growing unmet medical need. (Figure 1).6 To date, there have been no trials using a combination of both a biologic response modifier and an islet neogenesis agent in type 1 diabetes.

Figure 1: Combination therapy: Control Autoimmunity and Aid in Regeneration of Beta Cells

Research suggests that future therapies for type 1 diabetes may require an immune tolerance agent and a regeneration agent.



Figure 2: Plasticity of adult human pancreatic ductal tissue.

The single larger black cell (left) represents the presence of Reg, and the pink cell is a progenitor cell within the ductal population. Blue cells indicate beta cells, and red cells represent alpha cells, with delta cells present to a lesser extent in green. Reg is present in the early small islets that have just budded from the exocrine populations and is not present in the larger more mature islets.


Source: 2013 Levetan Pierce Distinctions Between Islets of Mice and Men (PDF)
by Claresa S. Levetan, MD, FACE; Susan M. Pierce, MPT, CDE

Taken together, Perle Bioscience, Inc. is conducting preclinical animal studies that will lead to FDA Investigational New Drug Studies to begin in man. Perle plans to complete both animal models for type 1 and 2 diabetes and early stage studies in man.


For full references please contact us here.

  1. Accessed 10/1/14
  2. Sundar SS,  Zhang P, Albright A et al. Medical Expenditures Associated With Diabetes Among Privately Insured U.S. Youth in 2007. Diabetes Care. 2011 34:1097-1101.
  3. Rosenthal E. Even small medical advances can mean big jumps in bills. New York Times 2014.  Accessed  8/25/14
  4. Tao B, Massimo Pietropaolo, M Atkinson M. Estimating the cost of type 1 diabetes in the U.S.: A propensity score matching method. PloS One. 2010;5(7)e11501
  5. Dall T, Mann S, Zhang Y. et al. Distinguishing the economic costs associated with type 1 and type 2 diabetes. Population Health Management. 2009;12:103–110.
  6. Levetan C, Pozzilli P, Jovanovic L. et al. Proposal for generating new beta cells in a muted immune environment for type 1 diabetes. Diabetes Metab Res Rev. 2013;29:604-606
  7. Matthews JB, Staeva TP, Bernstein PL. et al. Developing combination immunotherapies for type 1 diabetes: recommendations from the ITN–JDRF Type 1 Diabetes Combination Clinical and Experimental Immunology, Clinical and Experimental Immunology. 2010;160:176–184.

Photo Credit: “C. H. Best and F. G. Banting ca. 1924” by Unknown – University of Toronto.
Licensed under Public domain via Wikimedia Commons.

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