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 provided a corporate update on the clinical development of the Cell Pouch and projections for 2013. As well, it is pleased to announce the results of the 2013 Annual General Meeting (AGM).
Cell Pouch(TM) Corporate Update
In August 2012, Sernova initiated the enrollment of patients in a Phase I/II clinical trial in Canada to evaluate the safety (primary endpoint) and efficacy (secondary endpoint) of treating diabetes with transplantation of insulin-producing islets using its Cell Pouch(TM).
"We are continuing to enroll patients in this clinical study of Sernova's Cell Pouch(TM) and we expect to announce the first interim analysis of the data in the second half of 2013," said Dr. James Shapiro MD, Ph.D. FRCS (Eng.) FRCSC, principal investigator of the Cell Pouch(TM) study and Director of the Clinical Islet Transplantation Program at the University of Alberta.
Dr. Toleikis, President and CEO Sernova Corp added, "2013 is shaping up to be a most exciting year for Sernova. We look forward to sharing important developments while continuing our strategic plan to build Sernova into a leading technology company that will improve the health and quality of life for people with diabetes and other chronic diseases."
Sernova intends to complete the following corporate objectives in 2013:
- -- Continue the enrollment of patients into the Phase I/II study of the Cell Pouch(TM), and release interim results
- -- Develop and confirm an international clinical, regulatory and commercialization strategy for the Cell Pouch(TM) for the treatment of insulin-dependent diabetes
- -- Conduct preclinical studies of the safety and efficacy of Sernova's local immune protection technology, Sertolin(TM), within the Cell Pouch(TM) through the recently announced NRC-IRAP contribution agreement
- -- Initiate preclinical, safety and efficacy studies using stem cells or xenogeneic cells within the Cell Pouch(TM) which could eventually enable treatment of a much larger number of patients with diabetes than donor islets could provide alone
- -- Establish a corporate partnership to begin development of a new product indication for the Cell Pouch(TM)
- -- Prepare regulatory documentation for initiation of a second clinical indication for the Cell Pouch(TM)
Results of Sernova's 2013 AGM
Dr. George Adams (Chair), Jeffrey Bacha, James Parsons, Bruce Weber and Dr. Philip Toleikis, were elected as the directors of the Company to hold office until the next annual general meeting of shareholders.
Davidson & Company, Chartered Accountants, was appointed auditor of the Company until the close of the next annual general meeting of shareholders, at a remuneration to be fixed by the Directors.