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Aubrey de Grey a biomedical gerontologist, predicted that the first person
to live to a thousand has already been born. According to de Grey the key may
lie in the field of regenerative medicine.
The Webster dictionary defines biological regeneration as “the
restoration or the growth by an organism of organ or tissue, that have been
lost, removed or injured.”
Dr. William Haseltine CEO of Human Genome Sciences, believes
thatregenerative medicine is about assisting the body to heal itself. Dr.
Haseltine coined the term "regenerative medicine," to describe the
expected medical revolution that, in his view, could lead to human
immortality.
Stanford Universities Dr. Helen Blau wrote that the goal of regenerative
medicine is to restore form and function to damaged tissues.
I think we can decide for ourselves that regenerative medicine means
replacing, engineering or regenerating human cells, tissues or organs with
the goal being to re-establish normality for conditions that currently are
beyond repair.
“Cell therapy uses living cells as treatments. Its potential to cure
or transform serious medical conditions lies in the nature of cells and their
ability to interact with the body at levels of complexity many orders of
magnitude greater than conventional drugs. Regenerative medicine is focused
on the regeneration of tissues and organs using all the different therapeutic
platform technologies available: small molecule drugs, biologics, medical
devices and cells. Stem cell technologies, cell therapy and regenerative
medicine are closely entwined and will ultimately transform the practice of
medicine from today’s model of continual interventions to single
treatment cures.” Following Through: Realizing the Promise of
Stem Cells, KPMG
Stem cells
Stem cells are the foundation for every organ and tissue in your body.
Stem cell research is paving, or leading the way for the hugely
transformative and disruptive potential of regenerative medicine.
There are many different types of stem cells that come from different
places in the body or are formed at different times in our lives.
All stem cells can self-renew – clone themselves - and differentiate,
meaning they can develop into more specialized cells.
Embryonic stem cells
Embryonic stem cells are obtained from the inner cell mass of the
blastocyst, a mainly hollow ball of cells that, in humans, forms three to
five days after an egg cell is fertilized by a sperm. Embryonic stem cells
are pluripotent, meaning they can give rise to every cell type in the fully
formed body, but not the placenta and umbilical cord.
Tissue-specific stem cells
Tissue-specific stem cells (also referred to as somatic or adult stem
cells) are more specialized than embryonic stem cells. Typically, these stem
cells can generate different cell types for the specific tissue or organ in
which they live.
Induced pluripotent stem cells
Induced pluripotent stem (iPS) cells are cells that have been engineered
in the lab by converting tissue-specific (somatic/adult) cells, such as skin
cells, into cells that behave like embryonic stem cells.
Treatments include both in vivo and in vitro procedures:
- In vivo - studies and trials performed inside the living
body in order to stimulate previously irreparable organs to heal
themselves
- In vito - treatments are applied to the body through
implantation of a therapy studied inside the laboratory
Sernova Corp TSX.V – SVA
For the past 25 years, scientific laboratories around the world, with
specialty trained experts in cell technologies, were learning the processes
for how the body turns starting generalized stem cells into the mature
functional cells.
Recent scientific advances have turned these scientists towards developing
therapeutic cells to treat diseases such as Diabetes and Hemophilia. If
successful these technologies have the ability to treat millions of patients
unlike the currently available donor cells.
The ultimate goal of regenerative medicine for technologies that produce
proteins or hormones as therapeutics, is to develop an unlimited supply of
safe and efficacious therapeutic stem cells placed, in a simple procedure,
within the body in a cell friendly and retrievable medical device, while
being protected from immune system attack.
When the time came, Sernova Corp was determined to be in the forefront of
such technologies with strong proof of concept on their therapeutic device
with donor therapeutic cells within.
Knowing the importance of these developments, back in 2009, Sernova began
working on, and patented, a proprietary, scalable, implantable medical
device, their Cell
Pouch™ that creates a natural environment for the survival and function
of therapeutic cells.
The following examples are two diseases that regenerative medicine for
technologies that produce proteins or hormones as therapeutics has the
potential to cure and what the current state of treatment looks like.
Haemophilia
Hemophilia A - Occurs in about 1 in 5,000 births. Currently, the number of
people with hemophilia in the United States is estimated to be about 20,000,
an estimated 400,000 people worldwide are living with hemophilia and only 25%
receive adequate treatment.
Hemophilia is passed from parents to children. According to the U.S.
Centers for Disease Control and Prevention, hemophilia occurs in
approximately one in 5,000 live births. Even though this is an inherited
disease, approximately one-third of the cases occur due to spontaneous gene
mutation.
Hemophilia is a rare bleeding disorder in which blood doesn’t clot
normally due to the lack of sufficient blood clotting factor. Clotting factor
is a protein required for blood clotting to occur normally. These proteins
work with platelets i.e. small blood cell fragments that form in the bone
marrow, to help the blood clot.
There are several types of hemophilia, such as, hemophilia A, hemophilia B
(commonly known as Christmas disease) and hemophilia C. Hemophilia A is the
most common type of the disorder and is caused due to insufficient clotting
factor VIII. Hemophilia A is four times more common than hemophilia B (US$2 billion
market), and more than half of the patients with hemophilia A have a severe
form of hemophilia.
Hemophilia A patients receive prophy-laxis factor replacement therapy.
Prophylactic therapy (prevention therapy) involves three infusions of Factor
VIII each week at the hospital at a cost of about $260,000 each year.
The broader hemophilia A&B market is US$10 billion and is expected to
grow to US$13 billion by 2020.
The European Commission’s Horizon 2020 program has just awarded a $5.6M
Euro ($8.5M CAD) grant to the HemAcure consortium. The consortium consists 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.
The product being developed by the HemAcure consortium is expected to be
highly disruptive to the current standard of care treatments for hemophilia
A.
The reviewof
the HemAcure grant proposal stated the following:
“Participation
of the third country partner (Sernova Corp) is essential for carrying out the
(program). This is justified by the fact that the partner in question is the
one who possesses the technology that will be the basis of the whole
proposal, and which will perform all the in vivo studies. Sernova uses a
scalable, contract manufactured, proprietary patented worldwide implantable
medical device (Cell Pouch) transplanted with therapeutic cells. (It) has
been in development for more than six years and has shown success in multiple
small and large animal preclinical models and is now in a clinical trial for
another therapeutic indication. This Cell Pouch device is the only such
device that when implanted under the skin is proven to become incorporated
with blood vessel enriched tissue-forming chambers for the placement of
therapeutic cells. This implies that the Canadian partner (Sernova) is an
essential partner for the success of this project.”
About HemAcure
HemAcure is the name of the consortium developing a product for hemophilia A.
This project has received funding from the European Union's Horizon 2020
research and innovation program under grant agreement No 667421. The
consortium members include the University Hospital Wurzburg (Coordinating
Institute), Integrierte Management Systeme IMS e.K., Universita del Piemonte
Orientale “Amedeo Avogadro,” Loughborough University, GABO:mi Gesellschaft
für Ablauforganisation: milliarium mbH & Co. and Sernova Corp. The main
objective of the HemAcure project is to develop and refine the tools and
technologies for a novel ex vivo prepared cell based therapy within Sernova’s
prevascularized Cell Pouch to treat this bleeding disorder that should
ultimately lead to improved quality of life of the patients.
Diabetes
The World Diabetes Foundation estimates that there will be 438 million
people with diabetes by the year 2030. The global market for products in the
management of diabetes is on pace to grow to over $114 billion by 2018.
The top 10 companies producing diabetes medications raked in about $62
billion in global sales in 2014, up 5.1% from the previous year.
“Anti-diabetic products include glucose meters, lancets, test strips,
continuous blood glucose meters, insulin, insulin pumps, syringes and other
insulin delivery devices and anti-diabetic drugs. The bulk of product
revenues come from three segments - test strips, insulin and anti-diabetic
drugs - which will remain the largest sources of product revenues over the
next ten years. The most significant growth, however, will come from the
nascent segment of continuous blood glucose monitors, which provide
significantly added clinical benefit at only a modestly higher cost compared
to standard blood glucose meters.”Analyzing the Global Diabetes Market,
researchandmarkets.com
From a recently published paper ‘Diabetes Is Reversed in a Murine Model by
Marginal Mass Syngeneic Islet Transplantation Using a Subcutaneous Cell Pouch
Device’ comes the following…
"The emerging field of cellular transplantation involving
human-derived engineered stem cells is providing potential therapeutic
treatment options to benefit far more patients than donor cells can provide,
especially for diseases, such as type 1 diabetes. The future of these
therapies, aside from manufacturing aspects to improve safety, depends on a
suitable environment for the cells and cellular engraftment.
The current study demonstrates that the CP (Cell Pouch) placed in the
subcutaneous space provides a suitable environment for therapeutic islets as
effective as the renal subcapsular transplantation, at least in the murine
model. Furthermore, in subsequent assessment, it has been shown that the CP
scaled for human use can provide glucose control in large animal
transplantation models of diabetes (Sernova unpubl. results).
Thus, the CP system placed subcutaneously also meets the requirements for
scalable human islet transplantation. Further studies, which include
evaluation in the clinic are now required to demonstrate that the CP can
indeed serve as a potential alternative to clinical intraportal islet
transplantation, and provide a vehicle for future placement of alternate
cellular therapies in replacement and regenerative medicine. Indeed, the data presented
herein in addition to Sernova's large animal data (unpublished) formed
the experimental basis of a first-in-human trial using identical CP
technology currently underway in patients at the University of Alberta."
Results from the afore mentioned first-in-human trial using SVA’s Cell
Pouch(TM) were impressive…
“Encouraging early results up to 30 days post-islet 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 study was conducted with Dr. James
Shapiro as principal investigator at the University of Alberta Health
Sciences Centre in Edmonton, Alberta.”
Let’s visit SVA’s website from where
we get the following…
“In July, 2014 Sernova entered into an agreement with the University
Health Network of Toronto (UHN) to gain access to worldwide, exclusive rights
to certain patent-pending technologies. developed by distinguished UHN
researchers, Dr. Cristina Nostro and Dr. Gordon Keller, for the advancement
of insulin-producing stem cells for the treatment of patients with
insulin-dependent diabetes.
A product development program has been designed to advance the
technologies from preclinical proof-of-concept studies through to human
testing on an expedited basis.
Sernova believes the proprietary product – insulin producing stem cells,
protected locally from immune system attack and placed within Sernova’s
prevascularized Cell Pouch(TM) – has the potential to provide a significant
break-through in the quality of treatment for the tens of millions of people
suffering from insulin-dependent diabetes, following successful preclinical
and clinical testing. Such individuals could essentially be liberated from
their current onerous regime of daily blood glucose testing and insulin
administration delivered through injections or electronic means which is
expected to materially improve their quality of life while also reducing
short term and longer term health care costs.”
Conclusion
Harnessing the power of stem cells to repair or replace cells, tissues or
organs that are damaged by trauma or disease means we are entering an era
where treatments for some of the world's most devastating diseases are
developed.
Many companies have stem cells, most even have the ability to manufacture
them for various indications. In your author’s opinion, only Sernova Corp
TSX.V - TSX has a proven safe and biocompatible therapeutic device to host
these cells within the human body.
The transformational potential of stem cells, placed within Sernova’s
prevascularized Cell Pouch(TM), to cure diabetes and hemophilia could:
- Treat diseases in a much better way than traditional
drugs/treatments
- Significantly improve the quality of patient’s lives
- Offer a faster, more complete recovery with
significantly fewer side effects or risk of complications
- Reduce the cost of healthcare
- Prevent premature mortality
- Bring significant indirect economic benefits not only to
patients but society as a whole
Lab manufactured therapeutic stem cells hosted in the human body, in SVA’s
prevascularized Cell Pouch(TM), monitoring, regulating, manufacturing and
secreting the necessary hormones, factors and proteins to control diabetes
and hemophilia is a milestone accomplishment.
So does Sernova have Ponce De Leon’s fabled Fountain of Youth? No of
course not, but it would be hard to argue against my position that Sernova
Corp., and the regenerative medicine sector as a whole, has taken a huge step
along that road if upcoming human trials are successful.
It is an exciting time for regenerative medicine, the health care sector,
patients, and yes investors, with many disruptive innovations on the near
horizon.
Sernova Corp TSX.V - SXA is on my radar screen. Is it on yours?
If not, it should be.
Richard lives with his family on a 160 acre farm in northern British
Columbia, Canada. He invests in the resource and biotechnology/pharmaceutical
sectors and is the owner of Aheadoftheherd.com. His 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,
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SeekingAlpha, BusinessInsider, Investing.com, MSN.com and the Association of
Mining Analysts.
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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.
Richard owns shares of Sernova Corp TSX.V – SVA
Sernova Corp is a paid sponsor of Richard’s website aheadoftheherd.com
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