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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 trials
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.
Richard (Rick) Mills
Ahead of the Herd
Diabetes
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.
Haemophilia
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.
Conclusion
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. Is SVA
on yours?
If not, it should be.
aheadoftheherd.com
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:
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***
Legal Notice / Disclaimer
This document is not and should not be construed as an offer to sell or the
solicitation of an offer to purchase or subscribe for any investment.
Richard Mills has based this document on information obtained from sources
he believes to be reliable but which has not been independently verified.
Richard Mills makes no guarantee, representation or warranty and accepts
no responsibility or liability as to its accuracy or completeness.
Expressions of opinion are those of Richard Mills only and are subject to
change without notice. Richard Mills assumes no warranty, liability or guarantee
for the current relevance, correctness or completeness of any information
provided within this Report and will not be held liable for the consequence
of reliance upon any opinion or statement contained herein or any omission.
Furthermore, I, Richard Mills, assume no liability for any direct or
indirect loss or damage or, in particular, for lost profit, which you may
incur as a result of the use and existence of the information provided within
this Report.
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