Biotechnology Diabetes

A Pure Regenerative Medicine Play

by Richard (Rick) Mills, editor of aheadoftheherd.com

As a general rule, the most successful man in life is the man who has the best information

The promise of regenerative medicine is to treat disease and injury by replacing, regenerating or rejuvenating various parts of the human body that have been damaged by chronic disease, traumatic injury, heart attack, stroke, or aging. Treatments include both in vivo (studies and trials performed inside the living body) and in vitro (treatments applied to the body through implantation of a therapy studied inside the laboratory) procedures.

After many years of research the potential for regenerative medicine to redress the increasing prevalence of degenerative chronic diseases and acute injuries is beginning to receive huge scientific and public interest.

And no wonder! Look at some of the things we can already do…

  • Spina bifida suffers can now receive a bladder grown from their own cells.
  • Researchers have bioengineered a human liver that can be implanted into mice.
  • Heart disease affects the valves of the heart causing them to fail, we’ve already successfully grown heart valves from human cells.
  • Researchers have regenerated kidney tissue that is able to clear metabiolites, reabsorb nutrients and produce urine both in vitro and in vivo in rats.
  • Surgeons can now implant a tiny telescope within the eye helping restore some of the vision lost to end-stage age-related macular degeneration (AMD).
  • A material developed from the small intestines of pigs – small intestinal submucosa (SIS) – is used for everything from reconstructing ligaments, closing hard-to-heal wounds and treating incontinence.
  • Less complex organs such as the bladder and the trachea have been constructed from a patient’s cells and scaffolds and successfully transplanted.
  • Tissue-engineered vascular grafts for heart bypass surgery and cardiovascular disease treatment are at the pre-clinical trial stage.
  • New approaches to revitalizing worn-out body parts include removing all of the cells (decellularization) from an organ, and infusing new cells (recellularization) to integrate into the existing matrix and restore full functionality.

The first crop of simple stem cell therapies for regenerative medicine has reached widespread availability in the developed world. “Simple,” because these therapies are on the level of transfusions. In most cases stem cells are obtained from the patient, then grown in a cell culture and the greatly expanded number of cells injected back into the body. New medicine doesn’t get much simpler than that in this day and age. This is merely the start of a revolution in medicine, however, one will grow to become as large and as influential on health as the advent of blood transfusion or the control of common infectious diseases…Research continues, with a tone of excitement coming from the scientific community. They know they are onto something big.” Fightaging.org, Stem Cells, Regenerative Medicine, and Tissue Engineering

Some ongoing studies:

  • Diabetics treated with stem cell therapies that grow new insulin making cells.
  • Researchers are developing strategies to deliver proteins directly to the brain of stroke patients to stimulate stem cells and promote tissue repair.
  • Halting the progression of ALS, amyotrophic lateral sclerosis (also known as Motor Neuron disease and Lou Gehrig’s disease) and multiple sclerosis (MS).
  • Regrowing muscles in soldiers who were wounded in an explosion.
  • Restoration of Factor VIII in hemophiliacs.
  • The potential benefits of genetically enhanced stem cells in healing severe heart attacks.

It has to be pretty clear by now that regenerative medicine, although still in the early stages, is in the process of changing the practice of medicine.

These therapies will not only change healthcare, but will also lead to commercial success for the company and success in the market for investors.

One regenerative medicine company that’s currently off investors radar screens is Sernova Corp. (TSX-V: SVA, OTCQB: SEOVF, FSE: PSH).

However, with all Sernova has going on for it, the academic partnerships and R&D alliances, the company will begin to attract serious market attention, and possibly big pharma attention, in 2017.

Sernova Corp. is a clinical stage regenerative medicine company developing their Cell Pouch System™ for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.

Sernova Corp. has developed the subcutaneous Cell Pouch™ and has specifically designed it to overcome the issues with previous implanted devices for cell transplantation.

Sernova’s implantable prevascularized macro-encapsulated Cell Pouch™ is a versatile and scalable, first-in-class medical device made entirely of FDA approved materials. The Cell Pouch System™ provides a natural “organ-like” environment rich in tissue matrix and micro-vessels. This is the ideal environment for therapeutic cells to thrive which then release proteins and/or hormones as required.

Sernova’s extensive preclinical safety and efficacy studies have shown this device to be both safe and effective, while being sparing of islets, supporting its design and function. The Cell Pouch™ being thin and typically smaller than a business card, fits easily under the skin with virtually no visibility.

Sernova Corp.’s Cell Pouch™, using human donor islet cells to produce insulin, should begin formal U.S. Food and Drug Administration (FDA) directed clinical testing in Type I/II diabetes early in 2017.

Phase I clinical human testing with porcine-derived islets and formal human studies using stem cell-derived islet cells will follow.

Sernova has entered into partnerships with the University of Toronto (a stem cell-derived diabetes technology licensing/alliance), Harvard University and the University of Chicago.

Sernova has also entered into R&D alliances with leading regenerative medicine and disease-specific organizations like the University of Toronto-affiliated Centre for Commercialization of Regenerative Medicine and the Juvenile Diabetes Research Foundation.

Sernova’s Cell Pouch™ potential is not limited to just islet cell transplantation in diabetes. Sernova has an R&D collaboration ongoing to develop cell therapies for treating hemophilia A (already funded from the European Commission’s Horizon 2020 program), and a separate alliance with the University of British Columbia focused on thyroid disorders.

Regenerative medicine could potentially provide lasting solutions to some of the world’s leading chronic diseases. That will massively impact the medical industry in coming years. The regenerative medicine market, still in its infancy, offers a genuine opportunity for investors.

Big pharmaceutical companies are beginning to show increased interest by making various acquisitions and engaging in partnership programs with startup research companies.

“The rapid aging of the global population and the increasing prevalence of obesity is leading to a significant and growing rate of inflammatory and degenerative diseases of all types. These demographically driven changes are generating significant interest from large, multi-national pharmaceutical companies now targeting small biotechnology start-ups engaged in developing diagnostics and treatments for these degenerative diseases.”

By the year 2020, baby boomers – people aged 65 and up –  will outnumber children under age 5 globally. Also, by the year 2020, the Department of Health and Human Services predicts the market for regenerative medicine will reach $300 billion.

Companies, such as Sernova Corp., are the leaders in preclinical research and many, like SVA is, are entering Phase I/II clinical trials. These company’s become significant targets once they successfully get their products to a stage warranting the attention of the big players.

The magnitude of the present opportunity for an investment into Sernova is equaled only by the enormous potential return once one of SVA’s therapies reaches the market, or more likely draws the attention of big pharma.

A new branch of medicine will develop that attempts to change the course of chronic disease and in many instances will regenerate tired and failing organ systems.” Leland Kaiser, recognized futurist and acknowledged authority on the changing American healthcare system

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.

Lab manufactured therapeutic cells hosted in the human body, in SVA’s prevascularized Cell Pouch System™ monitoring, regulating, manufacturing and secreting the necessary hormones, factors and proteins to control diabetes and hemophilia would be a major accomplishment.

The transformational potential of stem cells, placed within Sernova’s prevascularized Cell Pouch(TM) 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

It would be hard to argue against my position that Sernova Corp., and the regenerative medicine sector as a whole, will have taken a massive step forward if upcoming human Phase I/II clinical trials are successful.

Sernova is today a relatively unknown pure regenerative medicine play that has partnered their Cell Pouch™ with a network of academic cell therapy research and development partners.

For these two reasons Sernova, and a well timed investment in the regenerative medicine space, best be on your radar screen. Is it?

If not, it should be.

Richard (Rick) Mills

aheadoftheherd.com

Richard lives with his family on a 160 acre ranch in northern British Columbia. He invests in the resource and biotechnology/pharmaceutical sectors and is the owner of aheadoftheherd.com.

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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, OTCQB: SEOVF, FSE: PSH). Sernova is an advertiser on Richard’s site – aheadoftheherd.com.