The World Economic Forum (WEF) and the Harvard School of Public Health report entitled “The Global Economic Burden of Non-communicable Diseases” estimates global diseases kill 36 million people every year and will cost upwards of US$47 trillion by 2030.

 

The World Health Organization's four biggest killers; cancer, heart disease, diabetes and chronic respiratory disease are dominant in non-communicable disease (NCD) mortality and morbidity. All four are increasing in prevalence  and the cost of treatment is spiraling out of control.

 

Exactly what is Diabetes?

Diabetes is a condition in which blood sugar levels are too high.

 

Much of the food you eat is broken down into a simple sugar called glucose. In response to a rise in glucose levels after a meal the islets beta-cells in the pancreas read 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.

A Type 2 (insulin resistance) diabetes diagnosis is a far more common verdict for people than Type 1. Insulin resistance happens because 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. Roughly 27% of the people who start out as Type 2 diabetics, will, in the future require insulin injections similar to Type 1 diabetics.

 

Between Type-1 and Type-2 patients with diabetes the total number of diabetics requiring insulin in just North America, is about nine million.

 

Sernova Corp. TSX:V-SVA is a Canadian-based medical device development company focused on chronic metabolic, neurological, and haematological diseases. Due to the enormous market and potential for significantly improved patient treatment, Sernova’s first product focus is on diabetes.

 

Sernova’s Cell Pouch System™ is a versatile, scalable credit card-sized device, made of FDA approved materials that provides a natural "organ-like" environment for therapeutic cells such as insulin producing islets for diabetics. Think of the Cell Pouch System™ as a potential natural insulin producing pump with the added benefit of fine-tuned glucose control. Placed under the skin in a simple inexpensive procedure it develops endocrine pancreas like characteristics when islets are placed into the device taking over normal glucose control. A key feature of the device is its ability to stimulate natural microvessel development, thought to be essential for long-term survival and function of therapeutic cells.

 

Sernova Corp. has received Health Canada approval to conduct a human clinical trial assessing both the safety and efficacy of Sernova's Cell Pouch with transplanted insulin-producing islets in patients with insulin-dependent diabetes. The study will be conducted in collaboration with Dr. James Shapiro at the University of Alberta Health Science Centre in Edmonton.

 

"Sernova's compelling pre-clinical results provide optimism that the Cell Pouch(TM) has the potential to change the standard of care of patients with diabetes receiving islet transplantation," said Dr. James Shapiro, principal investigator of the study. "I am excited to begin enrolment of patients in this ground breaking clinical study to evaluate the Cell Pouch(TM) in humans."

 

The study, entitled "A Phase I/II Study of the Safety and Efficacy of Sernova's Cell Pouch(TM) for Therapeutic Islet Transplantation," is an open label, non-randomized, single-arm, Phase I/II safety and efficacy study of up to 20 patients with insulin-dependent diabetes undergoing allograft pancreatic islet transplantation.

 

In this study, patients who have met the enrolment criteria and provided informed consent will be implanted with the Cell Pouch(TM) approximately

2-12 weeks prior to transplantation of donor human islets. To prevent islet graft rejection, patients will be treated with the standard immunosuppressive regimen.

 

The primary endpoint of the study is to assess the safety of the Sernova Cell Pouch(TM) in adult participants with Type-1 diabetes receiving islet transplantation for the first time. This endpoint will be assessed just prior to islet transplantation and one month thereafter.

 

The secondary endpoint of the study is to determine the proportion of subjects implanted with the Cell Pouch(TM) and transplanted with islets who achieve and maintain insulin independence as measured three months post-final islet transplantation.

 

In addition, the study will provide preliminary data on the efficacy of the Cell Pouch(TM) to maintain adequate immunological protection against both allo- and autoimmunity of islet transplant recipients.

 

Following assessment of primary and secondary endpoints, patients will be followed for a minimum of three years to assess long-term safety and efficacy of the Cell Pouch(TM). It should also be noted that the study allows for interim analysis of the data at various study time points.

 

"The initiation of this study marks a significant milestone for Sernova, and is the result of years of hard work and dedication from our company's staff and collaborators," said Dr. Philip Toleikis, President and CEO of Sernova Corp. "We have developed the subcutaneous Cell

Pouch(TM) for Sernova's first clinical application, insulin-dependent diabetes, as an alternative site for islet transplantation that may allow for safer, more efficient engraftment of islets and potential improved long-term insulin independence using a marginal islet mass. We are pleased to have Dr. Shapiro and his team conduct this study at this world class institute for islet transplantation."

 

The Cell Pouch(TM) is a proprietary medical device that, once implanted subcutaneously, incorporates with tissue and microvessels. It has been shown in multiple preclinical studies to provide a safe environment for transplantation, as well as long-term survival and efficacy of therapeutic cells. Sernova's goals for the diabetes indication include making the Cell Pouch(TM) available to a wider group of patients than currently possible with intraportal delivery of islets. Sernova also plans to make the Cell Pouch(TM) available as a natural, improved site for non-primary-derived, insulin-secreting cells for long-term function to enable large numbers of patients with insulin-dependent diabetes to be treated without limitation to availability of cells.