Sernova, Diabetes and Haemophilia

Richard (Rick) Mills
Ahead of the Herd

Page 1 of 2

As a general rule, the most successful man in life is the man who has the best information

 

Paul Lacey was a researcher at Washington University when, in 1972, he cured some diabetic rats by transplanting the islet cells from healthy rats into diabetic ones.

 

Over the next two decades researchers made many attempts to apply the procedure to humans. Unfortunately no one was successful. By the early 1990’s most scientists had come to the conclusion that islet-cell transplantation was a lost cause.

 

Drs. James Shapiro, Jonathan Lakey and colleagues from the University of Alberta in Edmonton were successful at improving the treatment of a select group with severe diabetes through development of the Edmonton protocol in the late 1990s.

The Edmonton Protocol is a method of transplantation of pancreatic islets into the portal vein of the recipient's pancreas. These pancreatic islets are sourced/extracted from pancreases removed from recently deceased adults.

 

Each recipient receives islets from one to three donors. The islets are infused into the patient's portal vein, and are then protected from the recipient's immune system through the use of two immunosuppressant drugs as well as an antibody drug specifically used in transplant patients.

 

Since 2000 close to a thousand people have received islet transplants – but by five years after the procedure, on average fewer than 10% of all patients are free of daily insulin supplementation. Thus, while islet cell transplantation has demonstrated exciting success and the potential for cell therapy as a treatment for diabetes has great promise, further technology developments are required.

 

Exactly what is Diabetes?

Diabetes is a condition in which the sugar levels in the blood are too high on a constant basis. Without tight blood sugar control to normal levels, this can result in severe long term medical consequences.

 

Much of the food one eats is broken down into a simple sugar called glucose. In response to a rise in glucose levels after a meal the islet’s beta-cells in the pancreas detect blood glucose levels and secrete insulin into the blood. Insulin acts to open the gates of cells allowing the glucose to move from the blood stream into the cells where it can be utilized for energy.


A Type 1 diabetes diagnosis means the pancreatic beta cells that read glucose levels and secrete insulin have been damaged or destroyed. Thus, glucose cannot move from the bloodstream into the cells allowing blood sugars to rise.

 

A Type 2 (insulin resistance) diabetes diagnosis is a far more common verdict for people than Type 1. Insulin resistance occurs as a result of chronically elevated blood sugar and insulin levels. These elevated levels of sugar and insulin have the effect of "numbing" the cellular processes which move the sugar from the blood stream to the cells - the body cannot respond to the insulin "requests" to move blood sugar into the cells. Approximately 27% of the people who start out as Type 2 diabetics, will, in the future require insulin injections similar to Type 1 diabetics.

 

Diabetic complications, which occur even in individuals taking insulin injections, include irreversible damage to the heart, blood vessels, eyes, kidneys, skin, feet and hearing. In individuals taking insulin injections to reduce blood sugar levels, severe hypoglycemia from a single injection of too much insulin, can cause organ failure, coma and death.

  

Diabetes is not considered a high mortality condition, but it is a major risk factor for other causes of death and has an extremely high attributable burden of disability, for example; 2% of people with diabetes become blind, about 10% develop severe visual impairment, and 50% of people with diabetes die of cardiovascular disease.

 

Standard of Care

 

The Standard of Care for patients with reduced or missing critical hormones or proteins, such as insulin, is often monitoring and injecting these proteins multiple times a day.

 

A search has been on for an alternative site for islet transplantation as well as for an optimal medical device in which to implant the islets (therapeutic cells). Several subcutaneous devices have previously been developed for islet transplantation but from a preclinical and clinical perspective the results from these products have been generally disappointing.

 

Current cell therapy is limited to poor cell survival, inappropriate delivery of hormones and a lack of available donors and cells. At this time there is no approved device to house and protect therapeutic cells in the body.

 

Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH)

 

Sernova Corp is a Phase I/II clinical stage company developing medical technologies for the treatment of chronic debilitating metabolic diseases to replace proteins or hormones in short supply within the body.

 

The first proprietary platform technology is the Cell Pouch System™. Think of SVA’s Cell Pouch System™ as a potential natural insulin producing pump with the added benefit of fine-tuned glucose control with no need to replenish the insulin. When placed under the skin and filled with islets it can develop pancreas-like characteristics taking over normal blood glucose control. The device uniquely forms highly vascularized tissue chambers for the placement, survival and function of therapeutic cells. Insulin producing islets transplanted in the device have been proven to become connected to microvessels and able to produce all of the regulatory hormones to control diabetes.

 

Sernova is exploring the additional utility of the Cell Pouch System™ as an enabling platform for a range of therapeutic cell types and diseases. The technology could be used for a patient’s own cells (autograft), or a donor’s cells (allograft).

 

The therapeutic cells placed into the device may also be cells that can be a source to treat millions of patients such as stem cell derived therapeutic cells (stem cells have the ability to differentiate into other cell/tissue types) or xenogeneic (derived or obtained from an organism of a different species) cells.

 

Sernova’s products are also designed to allow for multiple market expansion opportunities within each therapeutic area. For example, the technology would be beneficial if it provided a simple reduction in the number of daily therapeutic injections a patient must take; however, there is the possibility that it could even essentially ‘cure’ the disease through natural release and regulation of the therapeutic proteins or hormones.

 

Sernova’s trials

 

Sernova’s products are uniquely focused on those diseases in which a protein, hormone or factor, missing or in short supply in the body, could be replaced by therapeutic cells which release those factors into the bloodstream.

 

Diabetes and hemophilia are but two of the multibillion dollar market opportunities where such treatments could lead to:

  • A significant improvement in the quality of patient’s lives
  • Reducing health care costs
  • Potentially reduce the devastating side effects of disease

While other scientific laboratories around the world were advancing stem cell technologies which, if successful, would provide sources of therapeutic cells for various clinical applications, Sernova was in parallel working on their proprietary, scalable, implantable medical device (Cell Pouch System™) that creates a natural environment for the survival and function of these therapeutic cells.

 

Sernova is in the forefront of such technologies. 

 

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