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.
SSernova Corp. today released interim results in a continuing type 1 diabetes human clinical trial with the company's Cell Pouch.
Sernova's human clinical trial is designed to assess the safety and efficacy of the Cell Pouch in subjects with unstable diabetes receiving an islet transplant. Interim study results in the first group of patients support that the implanted Cell Pouch, transplanted with insulin-producing islets, is showing longer-term safety and biocompatibility with one of the patients beyond the 180-day time point.
Encouraging early results up to 30 days postislet transplant were presented at the International Pancreas and Islet Transplantation Congress in September, 2013. These results showed after implantation under the skin, the Cell Pouch is safe and biocompatible. Following islet transplantation, the islets living within a natural tissue matrix were supported with a rich supply of blood vessels, similar to the pancreas. Of further importance, the islets were shown to make insulin, somatostatin and glucagon -- key hormones in the control of blood sugar levels. The continuing study is being conducted with Dr. James Shapiro as principal investigator at the University of Alberta Health Sciences Centre in Edmonton, Alta.
"The fact that the Cell Pouch continues to exhibit both safety and biocompatibility in longer-term follow-up is an important milestone in the early clinical testing of this device and provides encouragement that human islets transplanted within the device may provide the opportunity to change the standard of care of patients with diabetes," said Dr. James Shapiro. "I look forward to the ongoing results of the investigation as the study progresses."
The study, entitled "A Phase 1/2 Study of the Safety and Efficacy of Sernova's Cell Pouch for Therapeutic Islet Transplantation," is an open label, non-randomized, phase 1/2 safety and efficacy study of up to 20 patients with type 1 diabetes undergoing allograft pancreatic islet transplantation. Patients who have met the enrolment criteria and provided informed consent are implanted with the Cell Pouch approximately two weeks to 24 weeks prior to transplantation of donor human islets. To prevent islet graft rejection, the standard of care immunosuppressive regimen is provided.
The primary end point of the study is to assess the safety of the Sernova Cell Pouch in these patients just prior to islet transplantation, following islet transplantation and at various points during follow-up. The secondary end point of the study, efficacy, is to determine the proportion of subjects implanted with the Cell Pouch and transplanted with islets who achieve and maintain insulin independence. Patient follow-up occurs for a minimum of three years to assess long-term safety and efficacy.
"In the second half of 2014, we expect to provide further preliminary safety and efficacy data," remarked Dr. Shapiro.
"This interim update by Dr. Shapiro suggests we are making positive strides forward. The Cell Pouch could potentially be a game changer for patients suffering from this debilitating disease. Indeed, this is the result of years of hard work and dedication from our company's staff and collaborators," said Dr. Philip Toleikis, president and chief executive officer of Sernova Corp. "We have developed the subcutaneous Cell Pouch 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. What adds further credence to the Cell Pouch's mechanism of action is the application of the Cell Pouch for other clinical indications, which Sernova is undertaking," added Dr. Toleikis.
About the Cell Pouch
The Cell Pouch is a proprietary, scalable, biocompatible medical device that, once implanted subcutaneously, incorporates with the patient's tissue and microvessels. The Cell Pouch is contract manufactured (ISO13485) to meet international regulatory standards. Sernova's research has demonstrated that when the Cell Pouch is inserted under the skin, it forms an ideal environment, rich in microvessels and tissue matrix for the placement and function of therapeutic cells. The Cell Pouch is currently being evaluated in clinical trials at the University of Alberta with Dr. Shapiro as principal investigator in patients with type 1 diabetes receiving an islet transplant.
It has been shown in multiple preclinical studies to provide a safe environment for transplantation, as well as for the long-term survival and efficacy of therapeutic cells. Sernova's goals for the diabetes indication include making the Cell Pouch available to a wider group of patients than currently possible with intraportal delivery of islets. Sernova also plans to make the Cell Pouch available as a natural, improved site for non-primary-derived, insulin-secreting cells. This may enable long-term treatment in large numbers of patients with insulin-dependent diabetes without limitation to availability of donor-derived cells.