contributed by Richard (Rick) Mills
Editor, Ahead of the Herd
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 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.
About 347 million people worldwide have diabetes. The World Health Organization (WHO) projects that diabetes will be the 7th leading cause of death in 2030.
July 12, 2016 – Sernova Corp. a clinical stage company developing disruptive regenerative medicine technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, is pleased to announce today it has entered into a research funding agreement with JDRF, the leading global organization funding and advocating for type 1 diabetes (T1D) research.
The purpose of the funding is to advance human clinical trials of Sernova’s
Cell Pouch System(TM) (CPS) technologies for treatment of hypoglycemia unawareness patients with severe type 1 diabetes. T1D is a life-threatening disease in which the body’s immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose.
JDRF will provide Sernova up to US$2.45 million to support a clinical trial at a major transplantation center in the United States. The goal of the study is to provide patients with hypoglycemia unawareness a novel cell therapy treatment utilizing Sernova’s proprietary, highly vascularized, cell macroencapsulated implantable and scalable device to reduce or eliminate the need for injections of exogenous insulin.
“Sernova’s progression to human clinical trials is an incredible accomplishment in the global diabetes research agenda. I am particularly proud of this trial being a part of the JDRF portfolio because it supports advancements of the best and brightest research minds in Canada at Sernova. Also, this is a shining example of the international collaboration fostered by projects funded by JDRF. Working together with our global partners, we can accelerate this type of transformative research and ensure it becomes available for the T1D community.” Dave Prowten, President and CEO of JDRF Canada.
Patients with hemophilia A have a defective gene for factor VIII. Patients receive prophylaxis factor replacement therapy two to three times a week. Prophylactic therapy (prevention therapy) involves three infusions of Factor VIII each week at a hospital at a cost of about USD$200,000/yr.
December 21, 2015 – Sernova Corp. announced today that the European Commission’s Horizon 2020 program has awarded a Euro 5.6M ($8.5M CAD) grant to a consortium consisting of Sernova Corp and five European academic and private partners to advance development of a GMP clinical grade Factor VIII releasing therapeutic cell product in combination with Sernova’s Cell Pouch(TM) for the treatment of severe hemophilia A
February 16, 2016 – Sernova Corp. announced today it has received its initial € 566,500 ($875,000 CDN) installment of non-dilutive funds from the HemAcure Grant funded by the EU Horizon 2020 Program. Sernova will use the payment to fund activities related to the development of a GMP clinical grade Factor VIII releasing therapeutic cell product combined with Sernova’s Cell Pouch(TM) to treat severe hemophilia A, a serious genetic bleeding disorder caused by missing or defective factor VIII in the blood stream.
“We are excited that the HemAcure consortium partners, a group developing a therapeutic that is highly disruptive to the current standard of care treatments for hemophilia A, are already working diligently to advance the program. Together, we are working to address, with a sense of urgency, the critical challenges posed by severe hemophilia A.” Dr. Philip Toleikis, Sernova President and CEO.
Since late December 2015, Sernova and its collaborative partners have announced funding of joint research hemophilia and diabetes collaborations totaling Cdn$11,780,000.00.
Individually each of these collaborations is massive validation of Sernova’s technology. Taken together they show a company on the cusp of being THE paradigm changer in science and they highlight Sernova’s capability to profoundly disrupt current standard of care.For this reason Sernova Corp has to be on everyone’s radar screen.
Richard (Rick) Mills
Richard owns shares of Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH)
Richard lives with his family on a 160 acre ranch in northern British Columbia and is the owner of Aheadoftheherd.com.
Richard’s articles have been published on over 400 websites, including: WallStreetJournal, USAToday, NationalPost, Lewrockwell, MontrealGazette, VancouverSun, CBSnews, HuffingtonPost, Beforeitsnews, Londonthenews, Wealthwire, CalgaryHerald, Forbes, Dallasnews, SGTreport, Vantagewire, Indiatimes, Ninemsn, Ibtimes, Businessweek, HongKongHerald, Moneytalks, SeekingAlpha, BusinessInsider, Investing.com, MSN.com and the Association of Mining Analysts.