We have a lot to go over so let's dive in.

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(PKTX) Is A Biotech Company That Could Be On The Verge Of Transforming Multiple Booming Industries

5 Potential Catalysts Lead The Way...

March 22nd

Greetings Readers,

We have a lot to go over so let's dive in.

I recently had an interesting idea come across my desk and felt it necessary to bring it to your attention ASAP. Here's why...

Multiple market opportunities.

When 2025 rolls around, you could be looking at the following potential industry sizes:

  • Ophthalmology industry is $35.7Bn (1)
  • Dermatology industry is $183Bn (2)
  • Organ transplant industry is $51Bn (3)
  • Biomanufacturing industry is $218Bn (4)

Choke on those for a second. LOL.

Now, once company who has recently moved above several lines of potential support in recent days could be nearing a game-changing discover that could shape future medical industries forever.

For Wednesday, March 23rd, there is one Biotech profile to have at the top of your watch-list:

*ProtoKinetix, Incorporated (PKTX)*

ProtoKinetix is a research and development company leading the way in cell survival solutions. AAGP®, our patented anti-aging glycopeptide, is a revolutionary discovery with incredible opportunity to shape the future of ophthalmology, dermatology, transplant support and biomanufacturing.

Based on a molecule found in nature and harnessed by a world-class research team, this anti-aging glycopeptide keeps more cells alive longer. It utilizes the same properties that help animals survive in arctic temperatures, and it has the capability to change regenerative medicine forever.

And right now, this profile has 5 potential catalysts to know ahead of Wednesday's opening bell. Check them out:

No. 1 - Profile Trades Above Key Lines Of Potential Support

No. 2 - Company Selects Two AAGP Formulations To Advance Into Preclinical Efficacy Testing

No. 3 - Partnering With NYSE Company To Accelerate Development Of AAGP

No. 4 - Resumption Of Phase 1b Clinical Trials For Use Of AAGP Treated Islet Cells

No. 5 - Peer Reviewed Research Publication Interpreting Results Examining Benefit Provided By AAGP

But more on those in a second...

ProtoKinetix Patented Molecule - Anti-Aging Glycopeptide (AAGP)

AAGP key benefits

AAGPs are small, stable molecules that display abilities in resolving challenges confronting medical researchers in regenerative medicine. Because of its molecular makeup, AAGP should function without side effects common in other treatments.

With AAGP, the company can get closer to affordable, accessible treatments for the conditions that affect our lives. See their greatest areas of opportunity:

Ophthalmology

By regenerating retinal cells in humans and animals, AAGP has the potential to treat millions suffering from dry eyes and blindness.

According to the Centers for Disease Control and Prevention, as many as 12 million Americans live with vision impairment. By regenerating retinal cells in humans, AAGP has the potential to treat people suffering from eye conditions.

The company is researching three major ways that AAGP can help: retinal cell transplantation, ocular inflammation and veterinary treatments.

Retinal cell transplantation

The company is in stage-3 of their pre-clinical retinal replacement program. The Gregory-Evans Retinal Therapeutic Lab at The University of British Columbia is testing whether AAGP treated cells continue to develop into retinal cells. If successful, this could lead to the restoration of vision in humans. For example, retinal cell replacement therapy could become a critical approach for the treatment of retinal diseases including Age-Related Macular Degeneration (AMD).

Ocular inflammation

Dry eye disease afflicts more than 30 million people in America and 430 million people around the world. The company is going to look into the effects of AAGP on ocular inflammation when applied topically. With this biotechnology, they're hoping to improve the quality of tears that lubricate and nourish the eye. This will help the hundreds of millions of people affected by this chronic issue.

Veterinary treatment

It’s possible that you don’t suffer from dry eye or other eye conditions, but your pets do. The company plans on researching AAGP in veterinary treatments. As they move through the discovery phase, they’ll narrow down their line of exploration to find out how they can improve ophthalmology care in animals.

Dermatology

Compared to preventative skincare products that need to be applied before environmental exposure, AAGP can recover skin cells after the damage is done, as demonstrated in a laboratory setting.

Chronic skin conditions can be both physically and mentally painful. In the United States, more than 85 million people are affected by skin conditions each year, according to the American Academy of Dermatology. AAGP can recover skin cells after the damage is done, as demonstrated in a laboratory setting. As a result, this molecule has the potential to make treatments for skin conditions more accessible and affordable.

The company is researching two major ways that AAGP can help: inflammation protection as well as UV-radiation and burn recovery.

Inflammation protection

The most common dermatological issue is inflammation. This can cause chronic conditions like eczema or rosacea. Occasional rashes can also occur from exposures to natural or chemical agents and sensitivities.

Your skin is your largest organ. When it becomes inflamed, visible reactions can happen. Figuring out what’s wrong and getting your skin back to normal is hard enough without answering questions from family and strangers about what’s wrong with your skin.

The company is in the preclinical research stage of discovering AAGP’s ability to protect skin from inflammation and are working hard to advance AAGP to clinical skin trials.

UV radiation and burn recovery

Currently, they're in the discovery phase to understand how AAGP can help skin recover from UV radiation and burns. Ultraviolet light can damage proteins and DNA in skin cells. It can also produce inflammatory mediators that increase cell death or alter skin elasticity and color. In their research, we’ve learned that AAGP could protect human adult skin fibroblasts against high intensity UVA and UVC wavelengths, which suggest that AAGP mechanisms of cell protection could both protect and renew healthy skin. They'll soon be moving on to the proof of concept and into preclinical stages of research.

Transplants

During today’s transplants, organs can only survive around four hours. With AAGP, they hope to extend their viability to 24 hours.

The impact: About 80 people receive transplants each day according to the Health Resources & Services Administration.

Regenerative medicine

Islet cells produce insulin, and Islet cell transplants are well recognized as a viable and effective treatment for unstable Type-1 diabetes. They are currently in Phase 1, first-in-human clinical trials to evaluate the safety and tolerability of AAGP PKX-001 treated Islet cells. PKX-001 is the designation given to the lead drug product molecule of the AAGP family for this application.

They are expanding Phase 1’s clinical trial to include testing on 10 patients. (This is in addition to the initial six patients.) The second half of Phase 1 will also include secondary objectives, including dose escalation to establish optimization criteria for efficacy testing. When Phase 2 begins, we’ll be evaluating the continued safety and efficacy of adding AAGP PKX-001 treated islets to the already established Edmonton Protocol for the treatment of Type-1 diabetes.

Whole organ support

The company is in the discovery phase of AAGP’s effects on whole organ support. They believe AAGP has the power to extend the length of viability far beyond four hours for organs used in transplants.

One of the most significant complications of diabetes is blindness, often as a result of diabetic retinopathy. Protecting the retina is a challenge, and replacing it has been greatly limited by the number of available organ donors. Yet, developments through improved access to new retinas by use of a patient’s own induced pluripotent stem cells to make retinal grafts have emerged. Keeping these retina cells viable using AAGP is the hope of numerous patients and doctors. Protokinetix has advanced their pre-clinical studies to stage-3 and recently reported our findings.

Biomanufacturing

In the realm of cell therapy and cancer immunotherapy, AAGP could be the link to essential advancements.

The impact: Over 1 million people have been treated by cell therapies worldwide according to the Transparency Market Research.

Biologics and biosimilars

The company is in the discovery phase of how biologics and biosimilars can be generated with the help of AAGP. With its ability to increase production yields of therapeutic antibodies used in immunotherapy treatments, this anti-aging glycopeptide could provide more hope for patients who have been diagnosed with cancer, autoimmune diseases, infections and other disorders. They believe that as a biotechnology additive they can help to lower costs and improve accessibility of next generation life-saving medical treatments for everyone.

Blood and cell product preservation

They're also in the discovery phase of their research on AAGP’s effects on blood and cell product preservation. The company has tested human and mouse neural stem cells to find out if AAGP could preserve the cell survival number during cryopreservation.

Find source and more details at the company website.

And right now, PKTX has 5 potential catalysts to firmly know. Check them out:

No. 1 PKTX Potential Catalyst - Profile Trades Above Key Lines Of Potential Support

Strong support levels could be growing for PKTX.

Take a look for yourself:

image

As of close on Monday, 3/21, PKTX was trading above several lines of potential support.

Those include its:

  • 5-Day Simple Moving Average (SMA)
  • 20-Day SMA
  • 5-Day Exponential Moving Average (EMA)
  • 13-Day EMA

If support is growing at these levels, it could act as building blocks towards a higher vertical move for PKTX in the near term.

Additionally, PKTX's 5-Day EMA is trading above its 13-Day EMA in what can be considered a bullish manner.

Watch these lines of potential support closely.

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No. 2 PKTX Potential Catalyst - Company Selects Two AAGP Formulations To Advance Into Preclinical Efficacy Testing

ProtoKinetix Announces Selection of AAGP Candidate Formulations for Treatment of Dry Eye Disease

MARIETTA, Ohio, November 23, 2021--(BUSINESS WIRE)--ProtoKinetix, Incorporated (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that it has selected two formulations of its Anti-Aging Glycopeptide (AAGP) product to be advanced into preclinical efficacy testing for the topical treatment of dry eye disease and ocular inflammation.

The selection follows a seven-month formulation development program conducted by Catalent, in which the Active Pharmaceutical Ingredient (API) was screened for ideal formulation conditions, with a number of potential excipients, to come up with a drug product that suits ProtoKinetix’s needs. The efficacy testing will be conducted by EyeCRO of Oklahoma City. This study should be completed by mid to late January 2022. The resulting lead formulation will then undergo extensive Good Laboratory Practice (GLP) toxicology examination, to prepare a submission for the U.S. FDA for its approval to conduct clinical trials.

"The relationship with Catalent has been extremely successful, and we believe this relationship will be ongoing for further development," said Clarence E. Smith, President and Chief Executive Officer of ProtoKinetix. "This is a very exciting phase for the Company as it moves toward the commercialization phase in the Dry Eye Disease sector. The Company’s highest priority is to create stockholder value through the development and commercialization of products and delivery technology."

ProtoKinetix is working on staffing key personnel to achieve our growing deliverables. This work incorporates retention of highly specialized personnel to advance the Company's product commercialization plan. To secure regulatory approvals, this includes the execution of the required safety toxicology, clinical trials, and engagements. To achieve these goals, the Company is pleased to have expanded the roles of our advisor and consultant teams to add Dana Nohynek (Regulatory Affairs Consultant & Project Manager) and Christopher Santos (CMC Specialist), both specialists that continue to provide expertise, meeting Company needs for product development.

Their expertise will be essential to the management of the production of ProtoKinetix’s AAGP product and regulatory agency formulation toxicology requirements near term (which will continue to be guided by the Company’s expert Toxicologist Consultant, Evelina Rubinchik, PhD). Along with the Company executives and medical science advisors, these specialists will inform and maintain our commercialization plan and industry partnerships.

Read the full article here.

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No. 3 PKTX Potential Catalyst - Partnering With NYSE Company To Accelerate Development Of AAGP

ProtoKinetix and IQVIA Partner to Support Development of AAGP Product in the Treatment of Ocular Conditions

ProtoKinetix, Incorporated (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced its collaboration with IQVIA (NYSE: IQV) to accelerate development of AAGP (PKX-001) in ocular conditions, specifically Dry Eye Disease and Wet and Dry forms of Age-related Macular Degeneration.

The ProtoKinetix-IQVIA collaboration will aim to accelerate the clinical development and regulatory progress of PKX-001. The collaboration is expected to drive directed clinical development as PKX-001 enters Phase 1 testing for the above conditions. This initiative will also serve to optimize these clinical trials to determine safety in these new conditions, drawing from previous experience with PKX-001 in Type 1 diabetes and other conditions.

Read the full article here.

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No. 4 PKTX Potential Catalyst - Resumption Of Phase 1b Clinical Trials For Use Of AAGP Treated Islet Cells

ProtoKinetix Announces the Resumption of Phase 1b Clinical Trials for the use of AAGP Treated Islet Cells in the Treatment of Type 1 Diabetes

ProtoKinetix, Incorporated (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced Phase I clinical trials of AAGP (PKX-001) treated islet cells have resumed at the University of Alberta, Edmonton. All clinical trials were paused in 2020 due to CV-19 restrictions in the province.

The Phase 1 trials, conducted by renowned surgeon Dr. James Shapiro, focus on the impact of PKX-001 treated islet cells transplanted into patients suffering from Type-1 diabetes. Data from the initial Phase 1a illustrated the safety of using the patented PKX-001 molecule as an enhancement to transplanted islet cells in six study patients. Study protocols have been modified for Phase 1b, focusing on the efficacy of the PKX-001 treated islet cells transplanted in a process known as the Edmonton Protocol. Under the new protocols, the first patient out of a total of 10 has entered into this Phase 1b trial Type-1 diabetes patients to be treated.

PKX-001 is the designation given to the lead drug product molecule of the AAGP family. Islet cell transplants are well recognized as a viable and effective treatment for Type-1 diabetes. The study will treat islet cells with PKX-001 prior to transplantation into informed patient participants. The clinical trials primary objective is to establish patient safety. We are now looking at optimizing these trials for efficacy by dose escalation. The study will also be making observations related to indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells. The trial follows extensive preclinical evaluation in experimental models (to learn more, refer to this link: Diabetes).

The trial is being led by Dr. James Shapiro, MD, PhD, FRCSC, MSM FCAHS, AHS Director of Clinical Islet and Living Donor Liver Transplant Programs, Canada Research Chair in Transplant Surgery and Regenerative Medicine, Professor of Surgery, Medicine and Surgical Oncology, University of Alberta.

"We are delighted to have increased dose and reactivated this exciting AAGP trial, and transplanted our next patient on April 12, 2021. We eagerly await definitive results as we move forward." – Dr. James Shapiro

[...]

Read the full article here.

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No. 5 PKTX Potential Catalyst - Peer Reviewed Research Publication Interpreting Results Examining Benefit Provided By AAGP

Journal of Tissue Engineering and Regenerative Medicine Publishes Peer Reviewed Research Paper Establishing ProtoKinetix AAGP Enhanced Stem Cell Vision Restoration

ProtoKinetix, Incorporated (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced the publication of a peer reviewed research paper describing and interpreting the results examining the benefit provided by AAGP to enable human induced pluripotent stem cell (iPSC) derived retinal precursor cells transplanted to restore vision in an experimental model of blindness due to retina degeneration. The paper has been published by the prestigious Journal of Tissue Engineering and Regenerative Medicine. The focus of this journal is therapeutic approaches which combine stem/progenitor cells with bioactive agents to restore, maintain, or improve tissue or organ function.

Journal of Tissue Engineering and Regenerative Medicine Paper on ProtoKinetix AAGP

Vision loss due to degeneration of the retina, most commonly the macula, commonly appears with aging, comorbid cardiovascular conditions, genetics, or other exposures. Age-related Macular Degeneration (AMD) currently has no cure and is the leading cause of blindness in the USA after deterioration in loss of reduced sharp central vision necessary for daily tasks like reading or driving. By 2050, the number of people in the USA with AMD is estimated to be 5.44Mn.

Age-Related Macular Degeneration (AMD) Data and Statistics

Cells transplanted without AAGP offered no benefits in electroretinography (ERG) or optokinetic tracking (OKT), which are advanced techniques used to measure vision function. By comparison, AAGP treated cells showed 3-fold greater improvement in both ERG & OKT — with more transplanted cells surviving long-term in the retina. Only AAGP treated cells showed maturation and integration with the host retina. This overcomes a significant challenge not previously achieved to offer new hope for AMD patients and opportunity for cell therapy products to succeed for clinicians in need of protecting cell for transplant.

This study was completed by Dr. Kevin Gregory-Evans, MD, PhD, Professor of Opthalmology & the Julia Levy Leadership Chair in Macular Research at the University of British Columbia. A panel member of the California Institute of Regenerative Medicine & Canadian Institutes of Health Research. Previously, a reader in molecular ophthalmology at Imperial College London. An ophthalmologist and global leader in macular research and regenerative medicine development.

"We have now completed both structural and functional studies in cell transplantation in model systems of blindness. Concurrent use of PKTX-001 has shown to significantly improve cell survival and integration into host tissue and will be a valuable asset in the field of regenerative medicine in the future." – Dr. Kevin Gregory-Evans M.D., Ph.D.

[...]

Read the full article here.

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PKTX Recap: 5 Potential Catalysts To Know Now

No. 1 - Profile Trades Above Key Lines Of Potential Support

No. 2 - Company Selects Two AAGP Formulations To Advance Into Preclinical Efficacy Testing

No. 3 - Partnering With NYSE Company To Accelerate Development Of AAGP

No. 4 - Resumption Of Phase 1b Clinical Trials For Use Of AAGP Treated Islet Cells

No. 5 - Peer Reviewed Research Publication Interpreting Results Examining Benefit Provided By AAGP

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Coverage is officially initiated on PKTX. When you have a moment, do this:

image

Get PKTX on your radar now.

Sincerely,

Kai Parker

StockWireNews


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