Health-care costs have spiraled out of control in most countries, especially the U.S., where people can’t seem to lead healthy lifestyles. The latest data (from 2016) shows that the adult obesity rates exceeded 35% in five states (led by WV at 37.7%), 30% in 25 states, and 25% in 46 states. Estimates are that obesity costs the U.S. more than $150 billion in health-care each year. Part of this is due to one in 11, or about 30 million Americans, having diabetes, a chronic condition that is often helped by weight loss.
Diabetes is characterized by high levels of blood sugar (also called "blood glucose"). Insulin is a hormone produced in the pancreas by the islets of Langerhans that regulate the amount of glucose in the blood. For people with diabetes, insulin is either not produced (Type 1 diabetes), not enough is produced, or the body doesn’t use it right (Type 2 diabetes).
People with Type 1 diabetes are insulin-dependent, meaning they must use a device (albeit a syringe or some type of automatic device) to inject insulin into their body to survive. Type 2 diabetic subjects can be either insulin-free or insulin-dependent, based upon their stage of disease.
Type 2 is the most common type of diabetes, accounting for about 95% of all cases. It is estimated that there are more than 40 million people with diabetes – both Type 1 and Type 2 – worldwide.
At the leading edge of new devices and therapeutic cells for treatment of diabetes is a small powerhouse, London, Ontario-based Sernova Corp. (TSX-Venture:SVA) (OTCQB:SEOVF), the creator of the revolutionary Cell Pouch System™.
The Cell Pouch is a novel implantable and scaleable medical device that forms a favorable environment within its chambers for the housing and long-term survival and function of therapeutic cells. The cells could be integral to any number of functions, including releasing necessary proteins or hormones missing from the body to treat chronic diseases, such as diabetes, as an alternative to daily administration of drugs.
About the size of a business card and manufactured from medical-grade, U.S. Food and Drug Administration-approved materials, the Cell Pouch is biocompatible and safe, as demonstrated in multiple pre-clinical studies and ISO10993 biocompatibility studies.
Studies have shown the device to be easily implanted under the skin and incorporate with vascularized tissue, eliminating the risks of fibrosis that accompanies other implantable devices. Sernova is also developing new technology for immune protection, which will lower any chance of anti-rejection drugs being needed.
In three different animal models of diabetes, the Cell Pouch was transplanted with insulin-producing islets and demonstrated efficacy by the animals achieving sustained glucose control. That was followed by a small clinical trial in Canada that proved safety and biocompatibility of the Cell Pouch™ with islets necessary for glucose production.
Now, the goal is to get this into larger-scale clinical trials as quickly as possible to see if the Cell Pouch can deliver the same results in people with diabetes as it did in the lab models.
To that end, the Juvenile Diabetes Research Foundation is contributing funding for an upcoming Phase 1/2 clinical trial in the U.S. The FDA has recently allowed Sernova’s Investigational New Drug (IND) application for a study evaluating the Cell Pouch System for the treatment of Type 1 diabetes in people with hypoglycemia unawareness.
In the study, patients will be implanted with the Cell Pouch and associated islets and followed for six months, at which time a decision will be made as to whether a second islet dose will be administered. Patients will then be followed for another year, with the primary endpoint being safety and secondary endpoint being signals of efficacy.
To keep an eye on glucose levels at all times, the trial is incorporating the continuous glucose monitoring system of Medtronic (NYSE:MDT), a marriage of diabetes devices that investors would surely like to see explored more in the future if the Cell Pouch performs as hoped.
While an addressable market of over 40 million certainly is appetizing, the beauty of the Cell Pouch is its diverseness, where it can be adapted to many different indications and areas of unmet medical need, including Hemophilia A, a disorder that Sernova scientists are already working on.
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