OTCBB: $PKTX - Protokinetix: Major advance in regenerative

Disclaimer: I’m a long-time shareholder and I’m excited about this company’s technology. I'm not a financial advisor, this is not financial advice, and I’m not being paid to write this. All this information is available on the company website (www.protokinetix.com), their YouTube channel ( www.youtube.com/channel/UCUd74SpJ0NtFiVtRjfznEUQ ) and from their news releases (on the website). Please do your own due diligence to confirm!

Summary

Protokinetix (OTCBB: PKTX) has developed AAGP, also known as PKX-001, a small glycopeptide which completely shuts down cell-level inflammation and dramatically increases the health, lifespan and functionality of all cells ever tested. This has literally dozens of applications in traditional medicine, regenerative medicine and over-the-counter products. Each application could be worth well over $1B to the company’s valuation. Yet the company is currently valued only around $35M (as of 13 Feb 2021).

$1B+ markets currently under development

Dry Eye Disease: This seems to be to company’s top priority. Protokinetix is developing a treatment for Dry Eye Disease, a multi-billion dollar market with no effective cure. Dry Eye Disease is caused by inflammation. Current drugs for Dry Eye Disease, such as Restasis and Xiidra, do not stop inflammation. Also, they irritate the eyes and have other side effects (for example, Xiidra is banned in Europe). AAGP completely stops inflammation, does not irritate the eye and is non-toxic. Protokinetix has completed all preliminary tests with excellent results. Novartis bought Xiidra for $3.4B. What would a real cure be worth?

Blindness: Blindness is generally caused by dead or non-functional retinal cells. Many teams are trying to cure blindness by transplanting stem cells into blind retinas in the hope that these cells will develop into functioning retinal cells. The problem is that the transplanted cells die after a few days. However, if you treat these cells with AAGP, they not only survive but they develop into fully functioning retinal cells, thereby restoring vision. Dr. Gregory-Evans (Julia Levy Leadership Chair in Macular Research at University of British Columbia) has successfully restored vision in genetically blind mice and rabbits by transplanting AAGP-treated human stem cells into their retinas. The same technique should be able to restore vision to blind people. The company is now seeking partners for human clinical trials.

Diabetes: Type 1 Diabetes can be cured by transplanting insulin-producing islet cells into a diabetic patient. The problems are low cell survival rates and low cell functionality. When the islet cells are treated with AAGP, they survive much longer and produce more insulin. This substantially increases the efficacy of the treatment and lowers the cost. Protokinetix is now entering the second year of human trials, with excellent results. The trials are led by Dr. James Shapiro of the Alberta Diabetes Institute. Dr. Shapiro is the founder of the Edmonton Protocol for Type 1 Diabetes and he largely invented this field.

Protection of transplanted cells and organs against immune system rejection: A fundamental problem in all cell, tissue and organ transplants is rejection by the body’s immune system. To help protect against rejection, patients are given anti-rejection drugs such as tacrolimus, cyclosporine and rapamycin. However, these drugs are toxic and cause side effects which can be serious. In testing performed by Dr. Gregory-Evans, AAGP-treated human stem cells, when transplanted into animals, were unaffected by the host’s immune system. Further testing is ongoing at the University of Dalhousie. The implications could be dramatic for the entire field of transplantation.

Cardiovascular medicine: AAGP protects cardiac cells from stress induced by nutrient overload or cardiotoxic drugs. Specifically, AAGP minimizes cardiac cell damage and improves viability when challenged with multiple stressors. Testing is ongoing at the University of Dalhousie, led by Dr. Thomas Pulinilkunnil.


$1B+ markets which, in my opinion, the company could easily enter.

Cosmetics, including high-performance sunscreen and creams for general skin protection, “anti-aging” and repair: Products for anti-aging and skin protection are a very big business. Most don’t really work. AAGP, however, has been extensively tested on human skin cells. In all cases, the cells live several hundred per cent longer, function better, and become resistant to acid, alkali, ultraviolet radiation, oxidative stress and other harmful influences. Therefore AAGP could be incorporated into cosmetics to produce the first ever truly effective skin-protection “anti-aging” creams. This could be a big deal in the cosmetics world. Also, because AAGP-treated skin cells are protected from UV damage, AAGP could be used to make high-performance sunblocks. Conventional sunblocks are quite inefficient, need to be reapplied often, are greasy, are often quite toxic, and can cause skin damage. AAGP on the other hand is non-toxic, non-greasy (it’s both fat- and water-soluble), makes the skin cells healthier and renders them unaffected by ultraviolet radiation. This would be another big market. Moreover, the formulation would be simple -- basically just adding a small amount of AAGP into a cosmetic cream base.

Cell / stem cell transplants across the entire field of regenerative medicine: This is a huge opportunity. Regenerative medicine is growing exponentially and most areas of regenerative medicine involve growing and/or transplanting cells. In every case, the challenge is to increase the cell yields, increase cell survival during manufacture and storage, increase cell survival after transplant, and increase cell functionality in the new host body. As the existing studies and human clinical trials show, AAGP dramatically helps all these areas. Therefore Protokinetix could develop $1B+ applications of AAGP throughout most areas of regenerative medicine.

Inflammatory eye diseases: Chronic inflammatory diseases that affect the eyes include uveitis, Graves’ disease and rheumatoid arthritis. There are no effective remedies. Once Protokinetix has launched its AAGP-based treatment for Dry Eye Disease, it would probably be logical to start developing a treatment for inflammatory eye diseases.

Inflammatory skin diseases: These include eczema, psoriasis, acne, rosacea, vitiligo, hives, seborrheic dermatitis and many others. There are no really effective remedies at this point since current drugs can treat the symptoms but cannot remove the underlying inflammation. Since AAGP eliminates inflammation, making a treatment for inflammatory skin diseases should be relatively straightforward. Also, AAGP has been tested extensively on skin cells, with excellent results.

Heart / liver / kidney transplants: Protokinetix says it is “now moving into whole organ transplantation ...” The challenge with organ transplants is to keep the organ healthy and functional while it is outside the body, and then to ensure that the organ functions properly when transplanted. It seems possible that by treating an organ with AAGP, we could prevent cells from weakening and dying, keep the organ highly functional and increase the organ’s functionality once transplanted.

Bone marrow transplants: Bone marrow transplants are an essential weapon in the fight against cancer. Many bone marrow transplants use cord blood (blood from an umbilical cord). The challenge is that cord blood cells are limited in supply, many die in storage, and they also degrade in functionality. According to Dr. McNagny, it seems possible that treating cord blood cells with AAGP would increase yields and functionality of cord blood cells.


Other key points

Strong and broad IP on both structure and application.

Leading academic partners.

Debt free. Funded by shareholders. This is pretty amazing. Generally, companies who have reached human trials and have multiple other development projects will have lots of debt, a high cash burn and big outside investors. Protokinetix has a very low burn (check out their SEC filings), no debt and no big VC investors to deal with.

Fully reporting.

Currently (13 Feb 2021) has market cap of only $35M, share price 12.5 cents, 288M shares outstanding, thinly traded.


What is AAGP?

AAGP is a synthetically produced molecule known as a glycopeptide. AAGP is very small, only 574 Daltons in size, and so it can easily penetrate tissues. AAGP is hyper-stable and non-toxic.

AAGP shuts down cell-level inflammation. Inflammation is the cause of many diseases and is linked to the aging process itself.

AAFP is proven (in vitro, in animals, and in humans) to protect cells from inflammation, oxidative stress, cold, heat, UV, acid, alkali, immune system rejection and other stresses.

AAGP greatly increases yields, lifespans, engraftment and performance of all cells, including skin cells, stemcells, monoclonal antibodies, B-, T-, CAR-T cells, etc.

AAGP suppresses expression of all tested known pro-inflammatory cytokines (IL 1b, IL 2, IL 6, TNFa, CXCL1) and inhibits expression of COX1, COX2, Prostaglandin E2, Caspase 3 and other inflammation-linked substances.

AAGP increases cell lifespan by three to five times, while maintaining and enhancing cell function.

AAGP is a molecule with a novel mechanism which could potentially lead to a new class of drugs. The precise mechanism of action is unknown. The effect of AAGP is to protect the cell against a wide variety hostile influences including pro-inflammatory stimuli. So when I say AAGP “eliminates inflammation”, I really mean that cells are protected from inflammation-causing stimuli, which pretty much comes down to the same thing.

AAGP is a synthetic version of a family of molecules known as anti-freeze glycoproteins, which keep fish such as arctic char from freezing in sub-zero temperatures. . These molecules have long been known to have many useful properties such as preserving animal tissues. However, these naturally occurring molecules are very large and so cannot easily penetrate animal tissues. Moreover, they are unstable and economically and ecologically unfeasable to harvest at scale.

Here’s the molecular formula:




Here’s a link to more information about AAGP: https://www.protokinetix.com/anti-aging-glycopeptide-aagp/


Papers

Paper “pre-print” (early release) in BioRxiv on restoring vision in genetically blind mice by transplanting AAGP-treated human stemcells into their retinas: https://www.biorxiv.org/content/10.1101/2020.11.22.393439v1

Paper published in Diabetes journal: https://drive.google.com/open?id=0B8HnH7IRbnI...HFYdkwxUm8 Shows that transplanted insulin-producing cells, when treated with AAGP, had twice the survivability increase from 31.5% to 67.9%. Insulin production increased over 10x.

Paper published in Journal of Tissue Engineering and Regenerative Medicine, showing increased survival of transplanted AAGP-treated cells: https://drive.google.com/open?id=1c1MlaMnU4YW...Oprhwu7eOb


Videos

Dr. James Shapiro on AAGP for islet cell transplants for curing diabetes: https://www.youtube.com/watch?v=_L7cSeMql4c

Dr. Gregory-Evans on AAGP for retinal diseases: https://www.youtube.com/watch?v=LrVocQyXNV8

Here’s a company overview by Dr. Keith Brunt: https://www.youtube.com/watch?v=AMcQ39kooO0&a...mb_rel_end

Dr. McNagny on AAGP for bone marrow transplants: https://www.youtube.com/watch?v=Bb_Fj_9Oi0c&a..._rel_pause

Two PKTX investors, one surgeon and one scientist: https://www.youtube.com/watch?v=A0BaXvFKPuA&a..._rel_pause