https://www.protokinetix.com/investors/pktx-investordeck-june2019.pdf
https://seekingalpha.com/instablog/47797823-melikemsmallstocks/5296806-pktx-life-changing-science-life-changing-stock
PKTX - A Life Changing Science And A Life Changing Stock
Apr. 25, 2019
ProtoKinetix, Incorporated (PKTX), Includes: CSBR
Summary
PKTX is where CSBR was 3 years ago.
PKTX's AAGP molecule is life changing.
Data is coming. With that comes higher stock price.
Those of you who have been following me the last few years, because of my call on Champions Oncology, CSBR, know that I have been predicting that ProtoKinetix PKTX is destined to be my next CSBR. The dynamics of each company and their respective stocks have parallels that can not go unnoticed.
For years CSBR had an incredible technology that the market had just not taken notice of. In 2014, 2015 and much of 2016 CSBR essentially traded by appointment and posted many zero volume days. Even a reverse split and an uplist to NASDAQ didn’t wake the stock up. Then around the 3rd quarter of 2016, the market finally took notice and we saw CSBR go from the high 1-dollar range to as high as $15 and some days trading several millions of dollars in volume. Why the big difference? Sure, they had some wins, they raised some money, landed a contract, increased revenues and brought on an IR firm, but at the end of the day, what really happened is, the market finally realized what they were all about. The market is not always efficient. Many great companies go unnoticed for years while many companies that are garbage enjoy the benefit of liquidity and over inflated market caps…dot com bubble, cryptocurrency, tulip bulb mania etc.
First, a little bit about ProtoKinetix. OTCQB:PKTX. ProtoKinetix is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP) that enhance both engraftment and protection of transplanted cells used in regenerative medicine. For those of you that are not biochemists or hold a PHD in immunology, let me simplify what this means. Very simply put, their AAGP molecule:
Is an anti-aging molecule
Increases cell survivability
Encourages cell growth
Increases cell viability
Improves cell functionality
Why is this important? Because the use of the AAGP molecule can be used to improve treatments of nearly every disease known to man. I know…that’s a big deal.
They began their first human trials in 2017. The trial is for the treatment of Type 1 diabetes with pancreatic islet transplants. The addition of AAGP to the transplant should increase the life of the islet, thereby increasing the success of the transplant.
AAGP is currently being tested or soon to be tested in the following:
Kidney Ischemia
Ischemia is a condition that occurs when blood flow to cells, tissues or organs is severely restricted. This condition can affect any part of the human body. When this happens, cell death and organ damage follows rapidly. Ischemia is a major cause of kidney damage, heart attacks and strokes. Testing will determine whether AAGP™ can reduce the inflammatory response that causes cell damage and organ failure that occurs during an ischemic attack.
Normothermic Liver Perfusion
Normothermic (body temperature), ex vivo (outside the body) liver perfusion (method of irrigation) is a therapy to livers outside of the body before transplantation. Again, simply put, AAGP, will keep the harvested organ viable longer. This can apply to any organ of the body. A true game changer for organ transplants.
Retinal Cell Replacement
Use of AAGP will improve the survival of stem cells that are currently being used in human trials to treat retinal blindness. Studies have already been completed at the University of British Columbia and showed dramatic improvement on cell survivability and viability, functionality with the addition of AAGP.
Monoclonal Antibody Production
Monoclonal antibodies are antibodies that are made by identical immune cells that are all clones of a unique parent cell, these are used in the rapidly growing field of immunotherapy. Monoclonal antibodies are currently being used to treat Cancer, Rheumatoid Arthritis, Multiple Sclerosis, Cardiovascular Disease, Systemic Lupus Erythematosus, Crohn's Disease, Ulcerative Colitis, Psoriasis, Transplant Rejection, and several more conditions.
By adding AAGP will lead to a dramatic decrease in the cost of production of monoclonal antibody medicines.
Bone Marrow Recovery
Bone marrow can be collected and cryopreserved. Conditions that can be treated by transplantation include bone marrow diseases, histiocytic disorders, hemoglobin opathies, inherited immune system disorders, inherited metabolic disorders, leukemias and lymphomas, myelodysplastic syndromes, multiple myeloma, plasma cell disorders, other cancers and malignant diseases. The inclusion of AAGP will increase functionality and viability of the bone marrow. This could then be expanded to all cryopreserved cells.
Cord Blood Preservation
Cord blood is the blood left in the umbilical cord and placenta immediately after birth. It can be collected, stored and used at any time during a baby’s lifetime to treat a wide variety of diseases and medical conditions. Cord blood is currently being used to treat multiple forms of cancer, hematopoietic diseases, inborn errors of metabolism and immune system diseases. You guessed it, AAGP will improve viability and function of the stored cord blood cells.
Ischemic Stroke Repair
Ischemic Stroke is associated with severe disabilities and a high recurrence rate. Testing of AAGP™ molecule is to prove it suppresses the inflammatory attack caused by ischemic stroke thereby preventing any long-term damage to the human body.
I could continue but I think that I’ve made my point. AAGP part of the future for the treatment of cancer, blindness, diabetes, transplants, stroke… AAGP conceivably could be used in every cutting edge treatment that we are currently aware of. We’re not just talking about one of two things it can treat, as stated before we are truly talking about nearly every ailment that affects the human body.
To be clear, these things are currently in trials and studies, but the results have been nothing but positive. Last year they announced their first working relationship with a large unnamed international biotech company. I believe we will see more of this. Given the enormity of the possibilities of this molecule, I see only one outcome for ProtoKinetix and that is a sell of the company. They are just too small to capitalize on such a vast technology.
Now that I’ve covered the science and its potential, let’s get into the nuts and bolts of the company. The company was essentially left for dead in 2012. No filings were made for over 18 months and the demise of the company was a given. Then in 2014, through the efforts of the current CEO, the company was revived. This is not the typically outcome for a micro-cap that is in trouble. By mid-2014, the company was current of their filings and back up and running. They also moved from Canada to the US.
Not only did they get going again, they are one of the tightest ran micro caps you will find. The 2018 cash burn for the company was just under $600k. This is remarkable for any public company but even more so for a biotech. In part they are able to keep expenses low due to the fact that most of their trials and studies are Investigator Sponsored by the University of Alberta, so the company isn't the one footing the bill for the research. Another reason for the low expense is the CEO’s salary is $1 a year. More on him later. To top it all off the company not only has no convertible debt it has no debt at all. Unheard of for a small biotech.
One last compelling thing about this company is the amount of insider buying. I can safely say; I have never seen as many Form 4’s from a company as I have seen from PKTX. The buying has been significant. To give you an idea, the current CEO’s initial form 3 that was filed in June of 2014, showed him owning 19,670,500 shares. His most recent form 4 shows him owning 61,353,833 shares. I’ll save you the math exercise, that is an increase of over 41 million shares. Some have been acquired through private placements, but a huge number have been bought in the open market. The past and current CFO were and are regular Form 4 filers as well.
So, the big question? Why is PKTX only trading at .08 with a $22 million market cap. There are a few reasons.
Like CSBR, they have been spending their time on building a business and increasing the value of their technology, rather than spending their time on pumping their stock up.
History. Like I said, the stock was left for dead and forgotten about. It takes a long time to recover from that. And legacy shareholders, I’m sure took advantage of an opportunity to get out, once they had the chance.
It’s a tough environment for OTC stocks. In a market that has been as good as what we’ve seen the last few years, people are content with the easy money being made in the big names.
Why buy now?
The technology…AAGP is a life changing molecule. Nearly unlimited upside.
Last year’s announcement of a Material Transfer Agreement with a global biotech company. Although the market didn’t take much notice, this is significant. It’s official, the big boys are starting to explore the AAGP molecule.
Data/Trials/Studies – Press this week announced they expect results from Phase 3 testing for Retinal Cell Replacement. Data is king and we’re starting to get it. Data is what will bring big biotech knocking…along with their checkbook.
No debt
Insider buying
It’s cheap. $22 million market cap is nothing for a company with a technology of this potential.
I do believe the time is now. ProtoKinetix not only has a life changing molecule, I’m also betting that PTKX will be a life changing stock.
Disclosure: I am/we are long PKTX, CSBR.
PROTOKINETIX INC.
CORPORATE OFFICE
412 Mulberry St,
Marietta Ohio 45750, USA
Tel: (304) 299-5070
EMAIL: contact@protokinetix.com
CEO:
Clarence E. Smith
www.protokinetix.com
BUSINESS MODEL
ProtoKinetix is building value for investors through licensing and joint ventures with business partners, utilizing our internationally patented technology- which is comprised of a family of glycoprotein compounds - targeting biotechnology applications where existing and developing businesses have requirements that AAGPs™ - anti-aging glycopeptides - will dramatically improve.
The biotechnology business is often subject to expensive and time consuming regulatory processes. Our approach is to expedite the development of our technology primarily through business relationships that provide us with leading-edge technical and marketing expertise to expedite the time lines to place products on the shelf.
ProtoKinetix is not about building a business with "bricks and mortar." We believe there are so many AAGP™ applications that can best be reached through strategic business relationships.
We assess each opportunity with return on investment as the priority. Defining and measuring each agreement based upon corporate investment, time line to market, strength of the organization within a specific market segment and marketing strengths.
As we build the value of AAGP™ we are also taking steps to generate revenue through sales of products in markets that do not require regulatory oversight.
COMMERCIAL APPLICATIONS
ProtoKinetix Successfully Completes Phase 1 Clinical Trials for the Treatment of Type 1 Diabetes in Islet Cell Transplants July 20, 2022 ProtoKinetix, Incorporated ( www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that the University of Alberta has successfully completed Phase 1 clinical trial enrollment for the treatment of type 1 diabetes in islet cell transplants. The molecule, PKX-001 (AAGP®) successfully achieved, to date, the primary safety objectives. The trial is continuing with observation of the latest enrolled patients to monitor secondary objectives over the next 6-months. Following this period of follow-up, all secondary objectives will have been evaluated in all patients, and the data will be collated, analyzed, and reported. The trial is being led by Dr. James Shapiro, MD, PhD, FRCSC, MSM FCAHS, AHS Director of Clinical Islet, Liver Transplant 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 excited to move forward with dose escalation in this exciting trial using this anti-aging glyopeptide molecule AAGP, and eagerly await data on how this might improve and protect islets after transplant. Certainly, at this point the data shows the molecule is safe” - Dr. James Shapiro. Dr. James Shapiro Bio To obtain additional information and monitor updates regarding this trial please use the following link: Clinicaltrials.gov – Islet Transplantation Using PKX-001. About ProtoKinetix, Incorporated ProtoKinetix Announces Selection of AAGP® Candidate Formulations for Treatment of Dry Eye Disease November 23, 2021
- ProtoKinetix, Incorporated (www.protokinetix.com) (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.
Dry Eye Disease Market Overview
According to market research published by Mordor Intelligence LLP, studies of the Dry Eye Disease market indicated a value of approximately USD 4.5 billion in 2018, and the market is expected to reach up to USD 6.2 billion by 2024, with an anticipated compound annual growth rate (CAGR) of 5.8%, during the forecast period (2020-2025). The growth of dry eye related diseases may include several factors, such as a significant increase in the population aged 65 and older, a decrease in the supportive hormones, systemic inflammatory diseases, ocular surfaces diseases or surgeries affecting the cholinergic nerves, which stimulate tear secretion. | |
ProtoKinetix and IQVIA Partner to Support Development of AAGP® Product in the Treatment of Ocular Conditions Marietta, Ohio, May 12, 2021 ProtoKinetix, Incorporated (www.protokinetix.com) (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. About IQVIA IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With approximately 67,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com. ProtoKinetix Announces the Resumption of Phase 1b
Clinical Trials for the use of AAGP® Treated Islet Cells in
the Treatment of Type 1 Diabetes Marietta, Ohio, April 22, 2021 ProtoKinetix, Incorporated (
www.protokinetix.com) (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 COVID-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, andtransplanted our next patient on April 12, 2021. We eagerly await definitive results as we move forward.” – Dr. James Shapiro Click here for Dr. James Shapiro Video Dr. James Shapiro Bio About the Edmonton Protocol Diabetes Research Institute Foundation Canada Video To obtain additional information and updates regarding this trial please use the following link: Clinicaltrials.gov – Islet Transplantation Using PKX-001.
See the promising research of AAGP® and results to date.
The Islet Cell Transplantation study is encouraging and additionally supports ProtoKinetix’s efforts to develop PKX-001 for other indications, including (but not limited to) stem cell transplantation in Wet and Dry Age-related Macular Degeneration and potential use in Dry Eye Disease. ProtoKinetix aims to investigate PKX-001 for these and other indications based on robust preclinical evidence. Visit our new website at ProtoKinetix.com for more information and to join our email list.
ProtoKinetix Engages Multi-National Partner for Formulation of Topical Drug to Treat Dry Eye Disease & Ocular Inflammation with AAGP®
Marietta, Ohio, April 14, 2021 ProtoKinetix, Incorporated (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that it has engaged a global pharmaceutical company to develop the formulation as a topical ocular drug for the treatment of dry eye disease (DED) and ocular inflammation using AAGP®. For the development of this drug for DED to date the company has completed:
- Ocular irritation studies
Proof of concept pre-clinical DED trials for efficacy
Confirmatory pre-clinical DED trials for efficacy
Pilot drug stability (ie. shelf-life) testing
Pilot tolerability and toxicology studies
All these studies were conducted by market-leading contract research organizations (CRO).
In order to progress to clinical trials, the Company intends to complete the following activities:
- Complete topical application formulation(s)
Confirmatory DED efficacy tests
Drug product Good Lab Practice (GLP) IND-enabling safety toxicology
Communicate with Fedral Drug Administration (FDA) on clinical trial design criteria
Dry Eye Disease Market Overview According to
market research published by Mordor Intelligence LLP, studies of the Dry Eye Disease market indicated a value of approximately USD 4.5 billion in 2018, and the market is expected to reach up to USD 6.2 billion by 2024, with an anticipated CAGR of 5.23%, during the forecast period (2019-2024). The growth of dry eye related diseases may include several factors, such as aging, a decrease in the supportive hormones (ex. menopause), systemic inflammatory diseases, ocular surfaces diseases or surgeries affecting the cholinergic nerves, which stimulate tear secretion.
“This is a critical milestone in our application development and moves us forward to commercialization of ProtoKinetix’s Dry Eye Disease program.” – Clarence Smith, CEO President See the promising research of AAGP® and results to date Visit our new website at
ProtoKinetix.com for more information and to join our email list.
***PKTX...Journal of Tissue Engineering and Regenerative Medicine Publishes Peer Reviewed Research Paper Establishing ProtoKinetix AAGP(R) Enhanced Stem Cell Vision Restoration
MARIETTA, Ohio--(BUSINESS WIRE)--April 07, 2021--
ProtoKinetix, Incorporated (www.protokinetix.com) (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(R) to enable human induced pluripotent stem cell (iPSC) derived retinal precursor cells transplanted to restor 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(R)
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 5.44 million. Age-Related Macular Degeneration (AMD) Data and Statistics
Cells transplanted without AAGP(R) offered no benefits in electroretinography (ERG) or optokinetic tracking (OKT), which are advanced techniques used to measure vision function. By comparison, AAGP(R) treated cells showed 3-fold greater improvement in both ERG & OKT -- with more transplanted cells surviving long-term in the retina. Only AAGP(R) 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.
Dr. Kevin Gregory-Evans on ProtoKinetix AAGP(R)
Dr. Gregory-Evans Bio
"We are happy to celebrate this milestone, which is the product of 5-years of intense research. This enables us as a company to focus on development and we will be looking forward to disclosing more on that in the near future." -- Clarence Smith, CEO President
Global ophthalmic therapeutics/drug market is expected to reach USD $35.7 billion by 2025, according to a new report by Grand View Research, Inc. According to market research published by iHealthcareAnalyst, the global market for organ transplantation is estimated to reach $51 billion by 2025, growing at a CAGR of 9.9% over the forecast period, driven by an aging population with increasing incidence of chronic disease, organ failures, and rising demand for transplant products, such as tissue products, immunosuppressants, and organ preservation solutions.
See the promising research of AAGP(R) and results to date
Visit our new website at ProtoKinetix.com for more information and to join our email list.
Research Paper Showing ProtoKinetix AAGP® Enhanced Stem Cell Derived Retina Precursor Cells Restoration of Vision..
11/24/2020
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced the submission of a research paper describing and interpreting the results analysing the benefit of PKX-001 on human induced pluripotent stem cell (iPSC) derived retinal precursor cells transplanted to an experimental model of blindness due to retina degeneration.
The paper has been submitted to a prestigious journal specializing in tissue regeneration for peer review and editing. Given the priority of this study, the paper has been made publically available now during the review process as a pre-print for a limited time for other stakeholders and scientists to review, discuss, or comment, here: https://www.biorxiv.org/content/10.1101/2020.11.22.393439v1
Vision loss due to degeneration of the retina, most commonly the macula, commonly appears with aging, comorbid cardiovascular conditions, genetics, or other exposures. Macular degeneration currently has no cure. It is the leading cause of reduced sharp central vision necessary for such tasks as reading or driving.
Cells transplanted without PKX-001 did not show any statistical benefits in electroretinography (ERG) or optokinetic tracking (OKT) used to measure vision function.
By comparison, PKX-001 treated cells showed 3-fold greater improvement in both ERG & OKT — with more transplanted cells surviving long-term in the retina. Only PKX-001 treated cells showed maturation and integration with the host retina.
“In this experimental model of retinal degeneration, iPSC derived retinal precursor cells treated with PKX-001 remarkably improved cellular integration after transplantation to secure functional vision benefits.” - Dr. Kevin Gregory-Evans M.D., Ph.D.
PKX-001 is the designation given to the lead drug product molecule of the AAGP® family.
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.
Dr. Kevin Gregory-Evans on ProtoKinetix AAGP®
Dr. Gregory-Evans Bio
Global ophthalmic therapeutics/drug market is expected to reach USD $35.7 billion by 2025, according to a new report by Grand View Research, Inc.
According to market research published by iHealthcareAnalyst, the global market for organ transplantation is estimated to reach $51 billion by 2025, growing at a CAGR of 9.9% over the forecast period, driven by an aging population with increasing incidence of chronic disease, organ failures, and rising demand for transplant products, such as tissue products, immunosuppressants, and organ preservation solutions.
“Our molecule offers significant benefits to the field of regenerative medicine already. Seeing more scientific success of this magnitude is exciting as we seek further partnership for clinical trials. Our company mission and values are to benefit patients in need and I am confident AAGP is the stem cell helper to do just that.” – Clarence Smith, CEO President
See the promising research of AAGP® and results to date
Visit our new website at ProtoKinetix.com for more information and to join our email list
ProtoKinetix AAGP® Restores Vision in Blind Test Subject
September 15, 2020
***ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that after the conclusion of 4-years of extensive testing, evidence of fully functional retinal cells was conclusively achieved. Based on these results Dr. Kevin Gregory-Evans shortly submitting a paper for publication in a peer reviewed journal.
***In vivo tests demonstrated that transplantation of PPCs (Precursor Photo Cells) pre-treated with AAGP® (PKX-001) results in statistically significant improvements in both the visual behavioral (optokinetic tracking test) and functional analysis (electroretinogram test) responses as compared with PPCs without pre-treatment. Imaging data revealed that pre-treatment of PPCs with AAGP® also leads to a substantial enhancement of cell survival as determined at 3, 4.5 and 6 months after cell transplantation. At the 6-month time point, the AAGP®-treated cells acquired the ability to express retinal and synaptic proteins, confirming that AAGP® has no adverse effect on precursor cells’ maturation. ***Macular degeneration, or age-related macular degeneration (AMD), is a leading cause of vision loss in Americans 60 and older. It is a disease that destroys sharp, central vision. Central vision is crucial for seeing objects clearly and doing tasks such as reading and driving.
AMD affects the macula, which is the part of the eye that allows you to see fine detail. AMD does not hurt, but it causes cells in the macula to die. There are two types of AMD: wet and dry. Wet AMD happens when abnormal blood vessels grow under the macula. These new blood vessels often leak blood and fluid. Wet AMD damages the macula quickly. Blurred vision is a common early symptom. Dry AMD happens when the light-sensitive cells in the macula slowly break down resulting in the loss of central vision.
***The study was conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia.
"We are very excited by these latest results showing functional benefits with these AAGP®-pre treated stem cells”. – Dr. Kevin Gregory-Evans
Dr. Kevin Gregory-Evans on ProtoKinetix AAGP®
Dr. Gregory-Evans Bio
***The success of these tests opens doors for ProtoKinetix AAGP® in the entire field of regenerative medicine. The next step towards commercialization is partnering with a major pharma to adapt AAGP® into their current clinical trial program. The global ophthalmic therapeutics/drug market is expected to reach USD $35.7 billion by 2025, according to a new report by Grand View Research, Inc. Ammendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials Have Been Approved by Health Canada
August 27, 2020 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that Dr. James Shapiro has received approval from Health Canada and the University of Alberta Ethics Committee for the ammendments to the clinical trial protocol. This phase of the clinical trials, based on safety data received from the initial studies in Phase 1, demonstrated the safety of the molecule and are now approved to adjust the protocols for optimal efficacy. The Company has been asked to deliver over 75-grams of the PKX-001 to the University to accommodate the ongoing clinical trial. 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 PKX-001 study will treat islet cells prior to transplantation into informed patient participants. The clinical trials primary objective is the establishment of 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 excited to continue our trials with ProtoKinetix and their anti-aging glycopeptide product in clinical islet transplantation. Our previous studies suggested this powerful agent could improve islet engraftment and protect islets from the toxic side effects of some of the anti rejection drugs. This trial is designed to test that. We eagerly await enrolment of our next patients.” – Dr. James Shapiro Dr. James Shapiro Bio Dr. James Shapiro Video About the Edmonton Protocol Diabetes Research Institue Foundation Canada Video To obtain additional information and updates regarding this trial please use the following link: Clinicaltrials.gov – Islet Transplantation Using PKX-001. See the promising research of AAGP® and results to date ProtoKinetix AAGP® Moves to Whole Organ Transplantation Testing 08/14/2020 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that due to the results that AAGP® has achieved over the previous years, we are now moving into whole organ transplantation, open heart surgery and cardiac ischemia treatment testing. “In our in vitro model of rat cardiomyocytes, pre-treatment with PKX-001 substantially increased cell survival under stress conditions (exposure to the lipotoxic fatty acid, palmitate and the anthracycline class of drug, doxorubicin). The mechanism of PKX-001 protective activity may in part be explained by its inhibitory effect on cysteine-type endopeptidase activity involved in the apoptotic signaling pathway. PKX-001 had no cytotoxic effect and minimally affected survival and normal functional activity of cardiomyocytes, both in vitro and ex vivo.” - Prof. Dr. Thomas Pulinilkunnil, Ph.D. PKX-001 is the designation given to the lead drug product molecule of the AAGP® family. This study is being led by Prof. Dr. Thomas Pulinilkunnil, Ph.D., Diabetes Canada Scholar, Associate Professor, Department of Biochemistry and Molecular Biology, Dalhousie University, Adjunct Professor, University of New Brunswick, Affiliate Scientist, Saint John Regional Hospital, Dalhousie Medicine New Brunswick (DMNB). Dr. Thomas Pulinilkunnil Bio According to market research published by iHealthcareAnalyst, the global market for organ transplantation estimated to reach $51 billion by 2025, growing at a CAGR of 9.9% over the forecast period, driven by increasing incidence of organ failures, and rising demand for transplant products such as tissue products, immunosuppressants, and organ preservation solutions. See the promising research of AAGP® and results to date Visit our new website at ProtoKinetix.com for more information and to join our email list. Ammendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials by the University of Alberta Submitted to Health Canada
July 13, 2020
....ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced an update to the Press Release of March 24, 2020. The ammendments to the clinical trial protocol have been submitted by the University of Alberta to Health Canada for their review. Upon approval from Health Canada and upon final approval by the University of Alberta ethics committee, the Company will be immediately delivering over 75-grams of the PKX-001 to the University to accommodate the ongoing clinical trial.
....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 PKX-001 study will treat islet cells prior to transplantation into informed patient participants. The clinical trials primary objective is the establishment of patient safety. We are now looking at optimixing 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.
Visit our new website at ProtoKinetix.com for more information and to join our email list. ProtoKinetix AAGP® Dry Eye Program Advancing
July 7, 2020 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX), a clinical-stage biomedical company, provides the following update regarding upcoming news in its Dry Eye Disease Program.
Dry Eye Disease (DED) – ProtoKinetix is expecting closure of agreements for the first steps in a roll-out of a new product line development that will test AAGP® for treatments related to Dry Eye Disease. Proof of concept work and basic formulation have been completed. Current project updates are expected from the following: - EyeCRO has been contracted to conduct confirmatory testing and dose ranging. Early progress reports from EyeCRO will be received over the next two weeks.
Charles River have been contracted to conduct pilot toxicology studies, to start at the end of July 2020. Early stage indications are expected by mid-August 2020.
Stability tests have been completed by Ambiopharm. The tests were conducted at room temperature, in a provisional formulation, under non-sterile conditions. These preliminary results are extremely encouraging.
“We are pleased with the progress made with respect to the expansion of ProtoKinetix’s Dry Eye Disease program.” - said Clarence E. Smith, President and Chief Executive Officer of ProtoKinetix. Dry Eye Disease Market Overview According to market research published by Mordor Intelligence LLP, studies of the Dry Eye Disease market indicated a value of approximately USD 4.5 billion in 2018, and the market is expected to reach up to USD 6.2 billion by 2024, with an anticipated CAGR of 5.23%, during the forecast period (2019-2024). The growth of dry eye related diseases may include several factors, such as aging, a decrease in the supportive hormones, systemic inflammatory diseases, ocular surfaces diseases or surgeries affecting the cholinergic nerves, which stimulate tear secretion.
***Please visit our new website at ProtoKinetix.com for more information and to join our email list.
ProtoKinetix Ready to Ship AAGP® to the University of Alberta for the Continuation of Phase 1 Human Trials
03/24/2020 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced an update to the Press Release of January 24, 2020. We have now completed the sterilization, quality assurance, labeling of the AAGP® (PKX-001) and are ready to ship the final product to the University of Alberta upon receipt of the NOL from Health Canada for the continuation of the Phase 1 clinical trials.
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 PKX-001 study will treat islet cells prior to transplantation into human test subjects. The clinical trials primary objective is the establishment of patient safety. 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.
Dr. James Shapiro Bio
Dr. James Shapiro Video
About the Edmonton Protocol
Diabetes Research Institute Foundation Canada Video
To obtain additional information and updates regarding this trial please use the following link: Clinicaltrials.gov – Islet Transplantation Using PKX-001.
See the promising research of AAGP® and results to date.
Visit our new website at ProtoKinetix.com for more information and to join our email list.
***COVID-19 Information as Applicable to ProtoKinetix***
In December 2019, the 2019 novel coronavirus (“COVID-19”) surfaced in Wuhan, China. The World Health Organization declared a global emergency on January 30, 2020, with respect to the outbreak and several countries, including the United States, Japan and Australia have initiated travel restrictions to and from China. The impacts of the outbreak are unknown and rapidly evolving.
Although we rely on third-party suppliers and manufacturers in China to produce AAGP® for testing, we believe we have sufficient quantities to last the Company for the next two years. Nevertheless, this outbreak has resulted in the extended shutdown of certain businesses, which may in turn result in disruptions or delays to our supply chain and restrictions on the export or shipment of our products.
Further, we cannot predict the availability of our scientists to continue testing or whether the trials can be completed. A widespread health crisis could adversely affect the global economy, resulting in an economic downturn that could impact demand for our products.
To date the outbreak has not had a material adverse impact on our operations. However, the future impact of the outbreak is highly uncertain and cannot be predicted and there is no assurance that the outbreak will not have a material adverse impact on the future results of the Company. The extent of the impact, if any, will depend on future developments, including actions taken to contain COVID-19.
ProtoKinetix Files for Patent Protection for AAGP® to be Used in Dry Eye Disease Marietta, Ohio, March 19, 2020 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) recently filed for patent protection for new applications of its AAGP® molecule. During recent testing conducted by EyeCRO of Oklahoma City, using a well-established animal model for Dry Eye Disease (DED), and Ocular Inflammation it was observed that AAGP® may have a substantial effect on the suppression and control of the disease. Based on these results the company has filed for patent protection with the United States Patent and Trademark Office (USPTO) for the application of DED. The patent application was submitted for both human and veterinary uses.
Dry Eye Disease is one of the most common ocular problems with an estimated prevalence of almost 5-million people over the age of fifty in the United States alone. Current therapies for dry eye are palliative with a focus on the replacement of tears to reduce symptoms. Over-the-counter artificial tear formulations are available. Punctual palliative therapies are also available, and while they have benefits over the short term, they have limited utility in long-term control therapy for dry eye. Cyclosporine A is the first prescription product for dry eye therapy, which increases tear production in patients whose tear production is suppressed. However, Cyclosporine A treatment presents disadvantages over the long term which could potentially be mitigated by AAGP®.
By protecting this technology, the Company is in a better position to move forward with its research in ophthalmological therapies. “Following the successful completion of recent testing of our AAGP® for dry eye disease, we need to ensure all our intellectual property is patented in order to protect its value.” - said Clarence E. Smith, president and chief executive officer. Please visit our new website at http://www.protokinetix.com for more information and to join our email list. ProtoKinetix Announces Progress in the use of AAGP® in Cardiovascular Medicine
February 19, 2020
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX) announces the progress of screening PKX-001 for cardiometabolic disorders “Using isolated cardiac cells, we demonstrated that PKX-001 exerts cardioprotective effects in cells that are exposed to stress induced by nutrient overload or cardiotoxic drugs. Specifically, PKX-001 minimized cardiac cell damage and improved viability when challenged with multiple stressors,” said esteemed biochemist and toxicologist, Dr. Thomas Pulinilkunnil. “This in vitro data supporting the therapeutic utility of PKX-001 is expected to augment the progress of the whole organ and animal studies while screening PKX-001 for inflammatory, hypertrophic and ischemic pathologies in cardiovascular medicine.”
*****See the promising research of AAGP® and results to date...
ProtoKinetix files for patent protection for the use of AAGP® in transplant medicine
February 11, 2020
ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB:PKTX) recently filed for patent protection for a new application of its AAGP® molecule.
During recent testing at The University of British Columbia, where photo receptors were transplanted into animal models, it was observed that AAGP® may have had a role in protecting xenografts and allografts from immune rejection from the host immune system, thereby helping the graft to survive and mature in the transplant recipient.
Immune rejection, leading to graft versus host disease (GVHD) is a primary concern present in almost all transplants, requiring the use of immunosuppressants such as cyclosporin, tacrolimus and rapamycin.
In addition to filing for patent protection, ProtoKinetix has started a major study at Dalhousie University to examine the effects of AAGP® in transplant medicine.
By protecting this technology, the Company is in a better position to move forward with its research in organ transplantation.
“We are pleased to protect this patent as we can now license the rights to other companies to develop different applications of the AAGP® lead compound,” said Clarence E. Smith, president and chief executive officer.
****Please visit our new website at ProtoKinetix.com for more information and to join our email list.
http://www.protokinetix.com
ProtoKinetix Takes Delivery of GMP AAGP® PKX-001 Dedicated for Phase 1 Trial | |
| January 24, 2020 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) announces that the Company has taken procession of an additional 200 grams of GMP grade PKX-001 (AAGP®) molecule. We are shipping sufficient molecule to Iotron Industries in British Columbia for sterilization. The sterilization process is a 1-week turnaround. After sterilization there will be one more process needed that will take up to 3-weeks for quality assurance. The sterilized molecule will then be sent to the University of Alberta for use in the continuation of the Phase-1 first-in-human clinical trials of PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type-1 diabetes. We are shipping ample molecule to include another 10-patients in the clinical trials. This represents the most significant scale-up of manufacturing in the Company’s history. Upon receipt of the molecule, request for approval of the amendments will be submitted to Health Canada by the sponsor, the University of Alberta. This total process will take 4-6 weeks.
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.
Dr. James Shapiro Bio
Dr. James Shapiro Video
About the Edmonton Protocol
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 PKX-001 study will treat islet cells prior to transplantation into human test subjects. The clinical trials primary objective is the establishment of patient safety. 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).
To obtain additional information and updates regarding this trial please use the following link: Clinicaltrials.gov - Islet Transplantation Using PKX-001. | |
ProtoKinetix AAGP® Dry Eye Therapy Testing Results | |
| January 6, 2020 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) announces that ITR Laboratories of Montreal have run multiple tests on eye irritation at maximum concentration of AAGP® and to date have shown no sign of irritation.
About ITR Laboratories
Based on this ProtoKinetix is shipping AAGP® to EyeCRO to commence testing Dry Eye Disease efficacy. This testing will involve topical application of AAGP® and evaluations of its effects on ocular inflammation. EyeCRO is a world recognised, specialised CRO in the field of pre-clinical ocular drug research and development. This program will commence in early January 2020 and is expected to run for 3-4 months.
About EyeCRO
About Dry Eye Disease
Dry Eye Disease is a condition in which a person does not have enough quality tears to lubricate and nourish the eye. Tears are necessary for maintaining the health of the front surface of the eye and for providing clear vision. Dry Eye Disease is a common and often chronic problem, particularly in older adults. This condition currently afflicts more that 30-million Americans (430-million people globally) and can affect as much as 40% of the population for various reasons. The dry eye disease ophthalmic market is very active, with $7.7 billion in revenues and a current growth of 12.5% CAGR. | |
ProtoKinetix AAGP® Retinal Cell Replacement Therapy Testing at UBC Completed | |
| December 19, 2019 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) announces the completion of an in vivo study to assess the effect of AAGP® on the long term survival and functional activity of photoreceptor precursor cells (PPCs) in the animal ocular model of genetic retinal degeneration.
The objective of this study was to determine the effect of 24-hour pre-treatment with anti-aging glycoprotein (AAGP®) PKX-001 at 4 mg/mL on the long-term (3, 4.5 and 6 months) survival and functional activity of PPCs) following their subretinal transplantation into the eye of nude immunocompromised rats with genetic retinal degeneration.
In vivo tests demonstrated that transplantation of PPCs pre-treated with AAGP® (PKX-001) results in statistically significant improvements in both the visual behavioral (optokinetic tracking test) and functional analysis (electroretinogram test) responses as compared with PPCs without pre-treatment. Imaging data revealed that pre-treatment of PPCs with AAGP® also leads to a substantial enhancement of cell survival as determined at 3, 4.5 and 6 months after cell transplantation. At the 6-month time point, the AAGP®-treated cells acquired the ability to express retinal and synaptic proteins, confirming that AAGP® has no adverse effect on precursor cells’ maturation.
Macular degeneration, or age-related macular degeneration (AMD), is a leading cause of vision loss in Americans 60 and older. It is a disease that destroys sharp, central vision. Central vision is crucial for seeing objects clearly and doing tasks such as reading and driving.
AMD affects the macula, which is the part of the eye that allows you to see fine detail. AMD does not hurt, but it causes cells in the macula to die. There are two types of AMD: wet and dry. Wet AMD happens when abnormal blood vessels grow under the macula. These new blood vessels often leak blood and fluid. Wet AMD damages the macula quickly. Blurred vision is a common early symptom. Dry AMD happens when the light-sensitive cells in the macula slowly break down resulting in the loss of central vision.
The study was conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia.
"AAGP® is proving itself to be a very useful pharmaceutical for markedly improving cell survival when transplanted into model systems. That this is important is proven by the functional benefits we are seeing in these models that would now warrant clinical trials." – Dr. Kevin Gregory-Evans
Dr. Kevin Gregory-Evans on ProtoKinetix AAGP®
Dr. Gregory-Evans Bio
The success of these tests opens doors for ProtoKinetix AAGP® in the entire field of regenerative medicine. The next step towards commercialization is partnering with a major pharma to adapt AAGP® into their current clinical trial program. The global ophthalmic therapeutics/drug market is expected to reach USD $35.7 billion by 2025, according to a new report by Grand View Research, Inc. | |
ProtoKinetix AAGP(R) Dry Eye Therapy Program Launched
11/22/19
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) announces the initiation of a program testing AAGP(R), to develop a potential therapy to treat Dry Eye Disease (DED). AAGP(R) has repeatedly demonstrated anti-inflammatory and cytoprotective properties, and also exhibits pharmaceutical properties beneficial for topical formulations.
The eye is extremely sensitive, so before efficacy testing can commence an eye irritation study will be conducted in accordance with both industry and regulatory requirements. This testing has been contracted to ITR Laboratories of Montreal who are a well-recognised CRO in this area. This testing is scheduled to commence in early December with results before January 2020.
About ITR Laboratories
In anticipation of a successful result from ITR Laboratories, EyeCRO, from Oklahoma City, have been contracted to conduct the efficacy testing. This testing will involve topical application of AAGP(R) and evaluations of its effects on ocular inflammation. EyeCRO are world recognised, specialised CRO in the field of pre-clinical ocular drug research and development. This program will commence in early January 2020 and is expected to run for 3-4 months.
About EyeCRO
About Dry Eye Disease
Dry Eye Disease is a condition in which a person does not have enough quality tears to lubricate and nourish the eye. Tears are necessary for maintaining the health of the front surface of the eye and for providing clear vision. Dry Eye Disease is a common and often chronic problem, particularly in older adults. This condition currently afflicts more that 30-million Americans (430-million people globally) and can affect as much as 40% of the population for various reasons. The dry eye disease ophthalmic market is very active, with $7.7 billion in revenues and a current growth of 12.5% CAGR.
Tests Show AAGP® Preserved and Enabled Retinal Cells to Mature Without Compromise after 5-Month Milestone
08/23/2019
ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB:PKTX) updates shareholders regarding ongoing 3rd stage testing of retinal cell replacement therapy at the University of British Columbia. As previously reported, the Company has demonstrated the ability of AAGP® to protect transplanted cells in a pre-clinical experimental model of retinal degeneration. For the purpose of these tests, the animals had a functioning immune system and so were treated with immune modulating drugs to model clinical practices. The results clearly demonstrated the ability of AAGP® to protect the delicate transplanted cells from the stress of the local microenvironment after transplant into the recipient at the four-week timepoint. Two questions under study have been answered:
- Do the transplanted cells survive in the recipient and safely continue to mature into functional retinal cells?
Does AAGP® interfere with the fated development of the transplanted cells?
In order to answer these essential questions, a comprehensive series of tests using immune suppressed animal models were designed. These tests included a long-term follow-up out to six months to determine if the cells continued to mature into photo-sensitive cells and whether the presence of AAGP® interfered with this essential development. At the five-month timepoint, the tests show that AAGP® preserved and allowed these cells to mature without compromise.
Pluripotent stem-cell therapy guided into retinal cells could potentially cure blindness even in the late stages of disease. However, until now, studies in animals have shown that too few transplanted retinal cells survive the hostile local environment long enough to integrate correctly into the retina’s complex neural circuitry. The AAGP® molecule in this study has overcome this considerable obstacle for stem-cell treatments that aim to replace retinal cells.
These studies are a critical component of the pre-clinical testing required to advance this program into clinical trials. The study is being conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia.
“We are now completing functional studies in two different animal models. These include electrical responses of the eye and also a behavioral test of sharpness of vision. Preliminary results show retention of vision function particularly in behavioral testing in the rodent model. Also, of note, we have not documented any adverse effects in animals when using AAGP®. Although our results are in relatively small numbers of animals (a dozen in each cohort of testing) this bodes exceptionally well for any proposed future clinical trial work.”
– Dr. Kevin Gregory-Evans
Dr. Kevin Gregory-Evans Video on AAGP®
Dr. Gregory-Evans Bio
ProtoKinetix Reaches Mid-Point of 3rd Stage of Retinal Cell Replacement Therapy Testing at UBC
| |
| July 9, 2019 ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) has reached the mid-point of 3rdstage of testing in retinal cell replacement therapy at the University of British Columbia. Functionality testing on experimental models three months post-transplant show encouraging results. We anticipate results from six-month post-transplant to be available within the next 4-5 weeks. The study includes two experimental models over a longer period of time to test whether the AAGP® treated cells continue to develop and mature into retinal cells to potentially restore vision in humans. The study is being conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia.
“We are pleased that our functional studies to date are looking positive and very significant.” – Dr. Kevin Gregory-Evans
Dr. Kevin Gregory-Evans on ProtoKinetix AAGP®
Dr. Gregory-Evans Bio | |
ProtoKinetix Achieves Primary Objective Safety at Midpoint of Clinical Trial | |
June 7, 2019
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) today announced reaching the midpoint of a Phase-1 first-in-human clinical trial of AAGP™ PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type-1 diabetes. All six patients were recruited and treated under this protocol. All primary safety objectives have been achieved at the midpoint in all study participants. As such, the protocol will now be amended to increase the number of participants in the trial with additional secondary objectives added including dose escalation to establish optimization criteria for efficacy testing. In order to satisfy the increased demand for the ongoing clinical trials and expanding research collaborations, the Company has ordered an additional 200 grams of GMP grade PKX-001 molecule. This represents the most significant scale-up of manufacturing in the Company’s history. Request for approval of the amendments will be submitted to Health Canada by the sponsor, the University of Alberta. 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. Dr. James Shapiro Bio
Dr. James Shapiro Video
About the Edmonton Protocol "We found this anti-ageing glycopeptide (AAGP™) compound to have surprising efficacy in our preclinical testing with human islets. Working with ProtoKinetix we have been able to rapidly move forward to early pilot clinical testing in patients. Thus far, the treatment has proved to be remarkably safe, and we are now in the process of increasing the dose with the goal being to substantially improve islet engraftment and survival in our islet transplant patients. We are especially excited about this trial!" – Dr. James Shapiro 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 PKX-001 study will treat islet cells prior to transplantation into human test subjects. The clinical trials primary objective is the establishment of patient safety. The study will also be make 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). To obtain additional information and updates regarding this trial please use the following link: Clinicaltrials.gov - Islet Transplantation Using PKX-001. | |
Agreement Secured by ProtoKinetix to Start Heart Research Product Validation Studies
May, 09 2019
MARIETTA, Ohio--(BUSINESS WIRE)-- ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) is announcing that the Company has secured a partnership agreement with IMPART investigator team Canada at Dalhousie University and has now commenced studies to reveal the benefits of PKX-001 (AAGP®) in cardiac metabolism. These studies will determine the efficacy of PKX-001 as a cardioprotectant and will be led by Diabetes Canada Scholar, Dr. Thomas Pulinilkunnil. As the director of the IMPART cardiometabolic research program, Dr. Pulinilkunnil leverages extensive training in molecular and metabolic sciences from his training at the University of British Columbia, the University of Alberta Heart Institute and Harvard Medical School. Dr. Pulinikunnil is currently a tenured Associate Professor at Dalhousie University, Faculty of Medicine in the Department of Biochemistry and Molecular Biology. Dr. Pulinilkunnil will utilize sophisticated techniques and experimental models of type-2 diabetes, cardiac ischemia, and cardioncology to evaluate the therapeutic utility of PKX-001 as a cardioprotectant.
Cardioprotectants are used extensively in hospital settings when the circulation is bypassed. They are components of cardioplegia solutions that protect the heart of patients from ischemia (low blood flow), such as during open-heart surgery or in preparation for heart transplantation. The metabolic protection identified in work-to-date by research laboratories using the ProtoKinetix product, AAGP®, as part of the Company’s product development strategy, has also opened up the potential for therapeutic protection of the heart during chemotherapy. Cardioncology is an emerging field of interest globally, as the cure rates of chemotherapy continue to improve and extend life. Ensuring that the heart is safe during chemotherapy is of paramount importance to several treatments regimens.
“I am very optimistic that our program will determine the therapeutic utility of PKX-001 as a cardioprotective molecule and I am confident that our team will identify, at least in part, some of the molecular mechanisms involved in the functionality of PKX-001. Glycopeptides, such as these, are inherently fascinating to me because they were inspired by the natural world. As such, the fundamentals have already been established biologically in nature in demonstrating their ability to self-protect tissues from harmful conditions like cold temperatures, low oxygen, and exposure to toxic agents. Developing innovative therapies inspired by fundamental science is exciting to me and our research team.” – Dr. Thomas Pulinilkunnil
About IMPART investigator team Canada
IMPART is a growing consortium of scientists and clinicians that are collaborating to better understand the common threads of chronic disease related molecular pathophysiology. The team seeks to deliver innovative medical solutions through research, development, and clinical trials. The focus of this consortium is to address the unmet medical needs of special populations and medical conditions involving inflammation, metabolism, and physical abilities through research translation. The team is particularly concerned with vulnerable patients, as they have the most to gain from new medical innovations. The team uses an interdisciplinary approach to develop research questions, as well as uncover and deploy novel solutions for unmet medical needs.
ProtoKinetix AAGP® in Phase 3 Retinal Replacement Program
04/23/2019
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) updates its stockholders regarding phase 3 of testing using AAGP® in retinal cell replacement therapy at the University of British Columbia.
The study is now using 2-animal models and a significantly larger number of animals in both control and AAGP® treated groups for a longer time frame. Until this study, the longest a group was tested for was 4-weeks. In this study, the lab currently has animals at the 3-month mark. All animals are reported to be healthy and behaving normally. Early results from this intensive program are expected to be presented to the Company by the end of July 2019. This study is being conducted to test whether AAGP® treated cells continue to develop into retinal cells. If successful, this may potentially lead towards the restoration of vision in humans.
This procedure could become a critical approach for the treatment of retinal diseases including Age-Related Macular Degeneration (AMD). The study is being conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia.
Dr. Gregory-Evans Bio
Dr. Gregory-Evans Video
The global ophthalmic therapeutics/drug market is expected to reach USD $35.7 billion by 2025, according to a new report by Grand View Research, Inc.
The retinal replacement program is just one of several ongoing studies involving our AAGP® molecule. Other ongoing studies are for:
- Type one diabetes, islet cell transplants. Currently in clinical trials.
Cord Blood Stem Cell Storage and Recovery.
Cord Blood Stem Cell Transplantation and Engraftment.
Protection and repair of cardiac damage due to toxicity or heart attacks.
Whole organ preservation extending time for human organ transplants.
ProtoKinetix Releases Third in a Series of Scientific Update Videos | |
February 26, 2019
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) announces the launch of the third in a series of informational videos by the Principal Investigators in each field currently being tested.
The third video is an update on the testing in the University of British Columbia. UBC will be testing AAGP™ ability to enhance the recover from storage as well as the survival and efficacy of engraftment of hematopoietic stem cells, a technical hurdle in cell-based therapies for bone marrow transplantation and cancer therapy.
The goal will be to determine whether AAGP™ enhances the ex vivo survival and maintenance of these valuable stem cells. The study is being conducted under the direction of principal investigator Dr. Kelly McNagny, Professor, Faculty of Medicine, Department of Medical Genetics.
Dr. Kelly McNagny Video ...http://protokinetix.com/videos/
Dr. Kelly McNagny Bio | |
***PKTX...ProtoKinetix Releases Second in a Series of Scientific Update Videos
January 16, 2019
MARIETTA, Ohio--(BUSINESS WIRE)--ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB:PKTX) announces the launch of the second in a series of informational videos by the Principal Investigators in each field currently being tested.
The second video is an update on the 3rd phase of testing in retinal cell replacement therapy at the University of British Columbia. Due to the positive results from the first two phases of testing where the AAGP® treated cells showed a dramatic increase in survivability versus untreated cells over a four-week period, we are now expanding the study. The new study shall include two animal models over a longer period of time to test whether the AAGP® treated cells continue to develop into retinal cells to potentially restore vision in humans. The study is being conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia.
Dr. Kevin Gregory-Evans on AAGP™http://protokinetix.com/videos/
ProtoKinetix Releases First in a Series of Scientific Update Videos
December 19, 2018
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) announces the launch of the first in a series of informational videos by the Principal Investigators in each field currently being tested.
The first video is an update on the clinical trial of AAGP™ PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type 1 diabetes 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.
Dr. James Shapiro on AAGP™
Click here for more on Dr. Shapiro and the Edmonton Protoco
****Here's a link.. http://protokinetix.com/videos/
ProtoKinetix Begins Cardiovascular Research
09/28/2018
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) Is pleased to announce the launch of a proof of concept study in the field of cardiovascular sciences.
Dr. Thomas Pulinilkunnil, Associate Professor, Department of Biochemistry and Molecular Biology, Dalhousie University is the principal investigator on this project. Pulinilkunnil laboratory will screen and examine the therapeutic utility of PKX-001 (AAGP®) against inflammatory, hypertrophic and ischemic pathologies in the heart . Upon the completion of this phase of testing, pre-clinicalscreening of organ preservation and metabolic effects of PKX-001 will be undertaken in transplant ready cardiac tissue. The overarching goal of this project is to develop PKX-001 as a cardioprotective agent with wide ranging applications in cardiovascular medicine.
ProtoKinetix AAGP® Molecule Moving Forward in Key Healthcare Studies Targeting Important Health Care Solutions
September 4, 2018
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX)
....President and Chief Executive Officer Clarence Smith is pleased at the progress of the health care applications projects the Company has underway. According to Mr. Smith “To that end, ProtoKinetix is continuing to collaborate with some of the most prestigious research institutions.
...The Company is focusing on research efforts in areas where our AAGP® molecule can significantly impact the success of healthcare outcomes.” I invite you to click on the links below for more detailed information.
***The company plans to introduce video content to its website that will allow for more detailed updates.
Current projects underway include the following:
1. Solutions for Diabetes Diabetes study currently in a Phase 1 human trial.
...Clinicaltrials.gov - Islet Transplantation Using PKX-001.
2. Solutions for blindness from age related macular degeneration Retinal Cell Replacement study has started Phase 3.
3. Immunology Studies
a) Cord Blood Stem Cell Storage and Recovery.
b) Cord Blood Stem Cell Transplantation and Engraftment.
c) Monoclonal Antibodies, ‘study completed’.
4. Solutions Enabling Healthy Survival of Strokes and Heart Attacks AAGP® Projects for Cardiac/Heart Research includes:
a) Suppression of doxorubicin toxicity
b) Glucolipotoxity protection
c) Endoplasmic reticulum stress mediation
d) Ischemic damage repair e) Whole heart ex-vivo preservation
****Research being conducted under proprietary MTA agreements include:
5. Solutions enabling increased healthy numbers of life saving stem cells Material Transfer Agreement ‘A’ includes studies for:
a) Cryopreservation of primary mammalian tissue cells
b) Enhancing the viability of primary mammalian cells
c) Cell lines under stressed culture conditions
6. Material Transfer Agreement ‘B’ includes studies for:
a) Immune Cell Cryopreservation recovery, ‘study completed’
****In Our Current Pipeline:
....Two studies with an undetermined start dates are Kidney Ischemia and Liver Perfusion.
....The company is actively negotiating material transfer agreements with other companies for collaborative research studies.
***CEO Clarence Smith notes that the company has adequate cash on hand for project continuation and company operations for the future.
ProtoKinetix Enters into 3rd Phase of Retinal Cell Replacement Therapy Testing at UBCPress Release..
08/10/2018
ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB:PKTX) has entered into the 3rd phase of testing in retinal cell replacement therapy at the University of British Columbia. Due to the positive results from the first two phases of testing where the AAGP® treated cells showed a dramatic increase in survivability versus untreated cells over a four-week period, we are now expanding the study. The new study shall include two animal models over a longer period of time to test whether the AAGP® treated cells continue to develop into retinal cells to potentially restore vision in humans. The study conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia.
Dr. Gregory-Evans Bio
The studies to date demonstrated that in vitro pre-treatment of PPCs with 4 mg/mL PKX-001 resulted in a substantial increase of cell survival following their transplantation into the subretinal area of immunocompromised rabbits with retinal degeneration. PPCs treated with PKX-001 maintained their ability to express key proteins associated with photoreceptor functions.
Based on the outstanding results thus far, ProtoKinetix now has patents pending in the United States of America, Canada and Europe.
ProtoKinetix will now extend its previous studies into further in vivo functional studies. To date we have histological data ex vivo and in vivo that PKX-001 improves PPC survival and that these cells mature to express proteins of mature photoreceptors.
The global ophthalmic therapeutics/drug market is expected to reach USD $35.7 billion by 2025, according to a new report by Grand View Research, Inc.
What does PPC...Stand For.. ...Photo Receptor Precursor Cell...
ProtoKinetix’ AAGP® Signs a Material Transfer Agreement with a Reputed International Biotech Company
June 13, 2018
...ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) is pleased to announce that ithas executed a Material Transfer Agreement (MTA) with a reputed biotechnology company having a number of worldwide offices on four continents.
Under the MTA, ProtoKinetix and this company are working together to test the effects AAGP®have on three projects: - Cryopreservation of Primary Mammalian Tissue Cells
Enhancing the Viability of Primary Mammalian Cells
Cell Lines Under Stressed Culture Conditions Before testing a drug in human patients, researchers use primary cells from different human donors to verify that the same effects are observed. Except for the enzymatic and/or physical dissociation required for extracting the cells from their tissue of origin, primary cells are not altered in any way. Primary Cell lines are hardy, chiefly because they have to last a long time in culture and be capable of surviving multiple rounds of cryopreservation and thawing.
Mammalian cell culture is at the core of bio manufacturing therapeutic proteins and viral vaccines. Cells isolated from animal tissues can be expanded in culture for use as a research tool for the production of virus vaccines and various therapeutic proteins, and to generate functional cells or tissue analogues for regenerative medicine. In the past quarter century, cells derived from animals, especially mammals, have become a major vehicle for producing biologics, a class of medications that includes vaccines and various proteins used in treating cancer, genetic diseases, and other ailments.
Mammalian cells can be made to produce vaccines through viral infection and therapeutic proteins through genetic engineering. Many of these medicines are necessary for patients who either lack the normal form of a protein or cannot produce it in sufficient quantity. Other therapeutic proteins include antibodies and specific binding proteins that neutralize disease-causing molecules within the body. Human cells, in particular, are poised to enable opportunities in cell-based therapy and regenerative medicine. The technology that exists now can derive stem cells from many sources and guide them to become specific cell types for clinical applications.
Preliminary results of the testing program are scheduled to be presented to ProtoKinetix by mid- summer. Should these results be successful, under the MTA, this company has the right to negotiate a licensing agreement for each application initiating the global commercialization of AAGP®.
Based on projections from Grand View Research, Inc., the global cell line development market size is expected to reach $3.96 billion by 2019 and is anticipated to grow at a compound annual growth rate (CAGR) of 12.9% over the forecast period. Growing biopharmaceutical industry is anticipated to drive the demand for cell line development procedures.
President and Chief Executive Officer Clarence E. Smith commented, “We are delighted to be collaborating with this reputed, international biotechnology companywith facilities worldwide. If testing proves to be successful, this may give ProtoKinetix the first opportunity to license out AAGP®”.
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ProtoKinetix Has Entered into a Research Agreement with The University of British Columbia to Test the Effect of its AAGP™ on Monoclonal Antibody Production and Bone Marrow Recovery
January 10, 2018
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) is pleased to announce that it has entered into a research agreement with The University of British Columbia (UBC), under the direction of principal investigator Dr. Kelly McNagny, Professor, Faculty of Medicine, Department of Medical Genetics.
Dr. Kelly McNagny Bio
This research agreement is to test and determine the effect of AAGP™ on monoclonal antibody production and bone marrow recovery.
The University of British Columbia’s Antibody Lab will test whether AAGP™ enhances the production of monoclonal antibodies from cell lines, an important manufacturing issue for current immunotherapies. UBC will also test whether AAGP™ enhances the survival/efficacy of engraftment of hematopoietic stem cells, a technical hurdle in cell based therapies for bone marrow transplantation and cancer therapy.
The goal will be to determine whether AAGP™ enhances the ex vivo survival and maintenance of multipotent potential in a way that could be used to enhance bone marrow transplantation. “If AAGP™ could enhance survival or, better still, aid in the expansion of stem cells in vitro, this would be of enormous clinical benefit” – said Dr. Kelly McNagny, Professor of Medical Genetics, UBC.
The goal of a bone marrow transplant is to cure many diseases and types of cancer. When the doses of chemotherapy or radiation needed to cure a cancer are so high that a person’s bone marrow stem cells will be permanently damaged or destroyed by the treatment, a bone marrow transplant may be needed. Bone marrow transplants may also be needed if the bone marrow has been destroyed by a disease.
A bone marrow transplant can be used to:
Replace diseased, non-functioning bone marrow with healthy functioning bone marrow (for conditions such as leukemia, aplastic anemia, and sickle cell anemia).
Regenerate a new immune system that will fight existing or residual leukemia or other cancers not killed by the chemotherapy or radiation used in the transplant.
Replace the bone marrow and restore its normal function after high doses of chemotherapy and/or radiation are given to treat a malignancy. This process is often called rescue (for diseases such as lymphoma and neuroblastoma).
Replace bone marrow with genetically healthy functioning bone marrow to prevent further damage from a genetic disease process (such as Hurler's syndrome, adrenoleukodystrophy or severe combined immunodeficiency (SCID)).
BIOGRAPHY - DR. KELLY MCNAGNY
Dr. Kelly McNagny obtained his Ph.D. in Cellular Immunology at the U. of Alabama at Birmingham in 1990. There he worked with Dr. Max D. Cooper (Howard Hughes Medical Institute, National Academy of Sciences) and his research focused on cell surface proteins that regulate B cell maturation and homing. He then moved to the European Molecular Biology Laboratory (EMBL) in Heidelberg, Germany where he performed his postdoctoral studies in the lab of Dr. Thomas Graf from 1991 to 1996. There his work focused on transcriptional control of hematopoietic stem cell maturation and cell fate. He performed some of the first studies to identify transcription factors that regulate the gene expression and differentiation of eosinophils, which are known to play a major role in allergic and asthmatic responses. In addition, he identified a number of novel hematopoietic stem cell surface proteins (the CD34 family) and began analyzing their function. He continued his studies at the EMBL as a semi-independent, Visiting Scientist from 1996 to 1998 prior to starting his own laboratory at The Biomedical Research Centre, at UBC.
He is currently a full professor in Medical Genetics at The Biomedical Research Centre where his work focuses on stem cell behavior, inflammatory disease, cancer biology and therapeutics.
In 2015 he also served as the Scientific Director of the Centre for Drug Research and Development (CDRD), a National Centre of Excellence aimed at translating early stage scientific discoveries into therapies.
He has garnered several awards including the 2004 Showell-Pfizer Junior Faculty Award from the American Association for Immunology, a MSFHR Career Investigator Award and a visiting professorship at the Phillip's University of Marburg. Kelly is a member of the Canadian Stem Cell Network Centre of Excellence (Sub-Chair of the Trainee Education Committee), Associate Director of the AllerGen Network Centre of Excellence, and Co-Director of AllerGen'sBiomarkers and Bioinformatics Platform.
***The Effects of ProtoKinetix’ Anti-Aging Glycopeptide (AAGP™) on Immune Cell Banking and Functions Relevant to
Immunotherapy
November 16, 2017
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) is pleased to provide a scientific update on immune cell banking and functions relevant to immunotherapy using AAGP™ in collaboration with Proactive Immune Sciences. Earlier in 2017, Proactive initiated a research program which utilized an anti-aging glycopeptide (AAGP™) produced by ProtoKinetix Inc. which, amongst other uses, has shown the potential to benefit various cells during cryopreservation. In this research program, Proactive is investigating whether the AAGP™ produced by ProtoKinetix Inc. improves survival and function of cryopreserved immune cells by focusing on the following objective:
1) Assessment of the effect of AAGP™ on cryopreserved immune cell viability and functionality.
Immune based interventions represent one of the fastest growing, most promising areas of personalized medicine. This is particularly true for cancer, which is largely a disease of immune failure. Therefore, there is a strong impetus for individuals to bank healthy immune cells at as early an age as possible, before these cells are compromised by infection, malignancy, or simply advanced immunological age. Proactive Immune Sciences Corporation will collect and cryopreserve all of the different types of immune cells present in blood for its clients. These cells can be used later for any form of immunotherapy the client might require. These cells can also be used for immune system regeneration to help restore an immune system that is compromised from chemotherapy or radiation treatments or even old age. Although cryopreservation of cells is commonly performed, Proactive would like to offer its clients the most advanced methods to ensure their cells are in optimal conditions for the processing required for these immunotherapies.
In May 2017, Proactive, with the support of the National Research Council of Canada (NRC) through an Industrial Research Assistance Program (IRAP) Grant, began testing AAGP™ in the cryopreservation process used to store Peripheral Blood Mononuclear Cells (PBMC). Cells were frozen using Proactive’s cryopreservation “cocktail” along with various concentrations of AAGP™.
A combination of Proactive’s cryopreservation “cocktail” and AAGP™ resulted in a 45% increase in viability of PBMCs over that of Proactive’s cryopreservation “cocktail” alone. When T and B cells were isolated from the frozen PBMCs post-thaw, both cell types displayed greater viability as well. These positive results were repeated with JURKAT cells, a T cell line used for research.
These findings have significance for immune cell based therapies. A 45% increase in the viability of PBMCs through the freezing process will result is significantly more cells being available should they be needed later for immune system reconstitution, requiring far less blood to be drawn. For patients, whose immune systems have been compromised from chemotherapy and/or radiation therapies, it could mean that they would now be able to participate in immune based therapies for which they previously could not provide enough viable cells.
Improved viability of T and B cells in the presence of Proactive’s cryopreservation “cocktail” and AAGP™ may provide a better starting material for the processing involved in several cellular therapies in development or recent approval such as CAR-T therapy for cancer.
The next phase of our research will explore the impact of Proactive’s cryopreservation “cocktail” and AAGP™ on functions of the immune cells pertinent to these developing cellular therapies.
About Proactive Immune Sciences
Proactive stores (banks) immune cells, while people are healthy, for them to use later in life should they contract cancer or have other immune system related diseases.
Having the rights to AAGP™ for immune cell cryopreservation enables Proactive to establish a unique foothold in the cell banking market and to provide services to other organizations that use frozen immune cells in their therapeutic processes.
Scientific Update for Diabetes, Kidney Ischemia, Liver Perfusion, Retinal Cell Replacement, Monoclonal Antibody Production and Immune Cell Cryopreservation Recovery
Oct 17, 2017
OTC Disclosure & News Service
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) is pleased to provide a scientific update to its stockholders. The Company is exploring the following areas for the use of its AAGP™ family of molecules:
Presently at the University of Alberta:
1. Diabetes (study started February 2017)
The PKX-001 (AAGP™’s clinical name) Study is treating islet cells prior to transplantation into human test subjects. The clinical trials are assessing any side effects or physiological damage to the test subjects. The study is looking for indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells.
The clinical trials are well underway and will continue throughout the end of the year with enrollment of up to ten patients. To obtain additional information and updates regarding the trials please use the following link: Clinicaltrials.gov - Islet Transplantation Using PKX-001.
2. Kidney Ischemia (anticipated start date 4th quarter 2017)
Ischemia is a condition that occurs when blood flow to cells, tissues or organs is severely restricted. This condition can affect any part of the human body. When this circumstance transpires, cell death and organ damage follows very rapidly. Ischemia is a major cause of kidney damage, heart attacks and strokes.
Our testing is to determine whether AAGP™ can reduce the inflammatory response that causes cell damage and organ failure that occurs during an ischemic attack.
3. Normothermic Liver Perfusion (start date to be determined)
Normothermic (body temperature), ex vivo (outside the body) liver perfusion (method of irrigation) is an innovative therapy applied to donor livers outside of the body before transplantation that improves organ quality and makes organs that were previously unsuitable safe for transplant.
Our planned testing is to determine the beneficial effects of adding AAGP™ to the perfusate solution. Perfusate solutions are used to protect donor organs from the period of harvest until transplantation. We hope to evidence that AAGP™ can extend the viable life of harvested transplant organs.
Presently at the University of British Columbia:
1. Retinal Cell Replacement (started June 2016)
The research program at the University of British Columbia, under the guidance of Dr. Gregory-Evans will be determining whether AAGP™ can help improve the survival of stem cells that are currently being used in human trials to treat retinal blindness. We are doing this because of the poor outcome in the current state of play using stem cells in the treatment of blindness. Proof of principal work has been done in animal models but these successes are few and far between. What has been seen most recently is that probably as few as 10% of injected cells are surviving more than a week. Although this is adequate for proof of principle work, it is not good enough for developing a clinical medical treatment. We are looking for ways to improve cell survival in actual living eyes.
The study conducted by the Gregory-Evans Retinal Therapeutic Lab at the University of British Columbia compared the results of transplanted retinal precursor cells with and without the addition of AAGP™. The cells treated with AAGP™ showed a dramatic improvement on cell survivability and viability, functionality compared to the untreated cells. Ongoing testing is now being conducted to determine if these transplanted cells are fully functioning.
2. Monoclonal Antibody Production (anticipated start date 4th quarter 2017)
Monoclonal antibodies are antibodies that are made by identical immune cells that are all clones of a unique parent cell. Monoclonal antibodies can have monovalent affinity, in that they bind to the same epitope. The use of monoclonal antibodies to treat diseases is called immunotherapy because each type of monoclonal antibody will target a specific targeted antigen in the body. Monoclonal antibodies are currently being used to treat Cancer, Rheumatoid Arthritis, Multiple Sclerosis, Cardiovascular Disease, Systemic Lupus Erythematosus, Crohn's Disease, Ulcerative Colitis, Psoriasis, Transplant Rejection, and several more conditions.
By adding AAGP™ into the culture medium, we are hoping to show a substantial increase in viable monoclonal antibodies that could lead to a dramatic decrease in the cost of production of monoclonal antibody medicines.
We are working at initiating programs on:
1. Bone Marrow Recovery (preliminary stage)
Bone marrow is the flexible tissue in the interior of bones. In humans, red blood cells are produced by cores of bone marrow in the heads of long bones in a process known as hematopoiesis. It can be collected and cryopreserved. Conditions that can be treated by transplantation include bone marrow diseases, histiocytic disorders, hemoglobin opathies, inherited immune system disorders, inherited metabolic disorders, leukemias and lymphomas, myelodysplastic syndromes, multiple myeloma, plasma cell disorders, other cancers and malignant diseases.
We will be testing to prove the viability and functionality of cryopreserved bone marrow increases with the addition of AAGP™.
2. Cord Blood Preservation (preliminary stage)
Cord blood is the blood left in the umbilical cord and placenta immediately after a baby is born. It can be collected, stored and used at any time during a baby’s lifetime to treat a wide variety of diseases and medical conditions. Cord blood is currently being used to treat multiple forms of cancer, hematopoietic diseases, inborn errors of metabolism and immune system diseases.
We will be testing to prove the viability and functionality of cryopreserved cord blood cells increases with the addition of AAGP™.
3. Ischemic Stroke Repair (anticipated start 4th quarter 2017)
Ischemic Stroke is usually associated with severe disabilities, high recurrence rate and other poor outcomes. Currently, there are no long-term effective treatments for stroke. Cell therapies have been explored previously. However, the therapeutic outcomes are often limited by poor survival of transplanted cells, difficult delivery, uncontrolled cell differentiation, ineffective engraftment with host tissues and non-sustained delivery of growth factors.
We will be testing to demonstrate that the AAGP™ molecule suppresses the inflammatory attack caused by ischemic stroke thereby preventing any long term damage to the human body.
Proactive Immune Sciences is conducting research on:
1. Immune Cell Cryopreservation Recovery (started June 2017 - anticipated end date 4th quarter 2017)
Immune based interventions represent one of the fastest growing, most promising areas of personalized medicine. This is particularly true for cancer, which is largely a disease of immune failure. Therefore, there is a strong impetus for individuals to bank healthy immune cells at as early an age as possible, before these cells are compromised by infection, malignancy, or simply advanced immunological age. The ability to use immune cells provides an oncologist another major tool in their arsenal to fight cancer.
Results to date have been very encouraging. We are hoping to prove the functionality of cryopreserved immune cells increases with the addition of AAGP™ on the immune cell cryopreservation protocols used by Proactive Immune Sciences.
“We are delighted that research continues to support a growing belief in the potential benefits of AAGP™ for an expanding spectrum of medical applications. Through our international partnerships and academic relationships, we continue to explore and participate in well-designed scientific studies in support of a fundamental understanding of how AAGP™ can benefit numerous medical conditions. We are encouraged by the growing clinical data to support the effectiveness of AAGP™. I look forward to updating our stockholders with additional results as they become available as well as releases that will give a better understanding as to why we are conducting the study.” - Clarence E. Smith, President and Chief Executive Officer.
ProtoKinetix and Proactive Immune Sciences Announce a Joint Research Collaboration Using AAGP™ in Immune Cell Cryopreservation Testing
June 05, 2017
ST. MARYS, W. Va.--(BUSINESS WIRE)--ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) and Proactive Immune Sciences (www.proactiveimmunesciences.com) today announce that they have entered into a joint research collaboration. The goal of the research will be to test the effect of the patented anti-aging glycopeptide AAGP™ on the immune cell cryopreservation protocols used by Proactive Immune Sciences.
“We welcome the opportunity to show the effectiveness of our AAGP™ molecule in another rapidly expanding, high-demand, commercial arena, further demonstrating the versatility of this molecule’s ability to protect cells in different clinical situations”
“We are excited about this new joint research collaboration and hope AAGP™ has some of the same positive effects, with respect to cryopreserving immune cells, that it is having on other cell lines,” says Jeff Schulz, CEO, Proactive Immune Sciences. “We are hoping to prove through our research that AAGP will have a positive affect on helping immune cells recover from the cryopreservation process. Any improvement in cell survival rate, or cell function could have significant, positive benefits for future treatments using cryopreserved immune cells.
Pending a successful outcome of our research, the intent is for Proactive to enter into a licensing agreement with ProtoKinetix for the cryopreservation of immune cells. This will give Proactive customers the benefit of knowing their stored immune cells will perform at the highest levels possible should they require them for any immune cell based cancer or immune system reconstitution later in their life.”
About Immune Cell Banking
The initial phase of the research is expected to conclude later in 2017. Partial funding for the project has been provided by The National Research Council’s Industrial Research Assistance Program.
About the National Research Council's Industrial Research Assistance Program
Immune based interventions represent one of the fastest growing, most promising areas of personalized medicine. This is particularly true for cancer, which is largely a disease of immune failure. Therefore, there is a strong impetus for individuals to bank healthy immune cells at as early an age as possible, before these cells are compromised by infection, malignancy, or simply advanced immunological age. These cells can be used later on for any form of immunotherapy the client might require.
“We welcome the opportunity to show the effectiveness of our AAGP™ molecule in another rapidly expanding, high-demand, commercial arena, further demonstrating the versatility of this molecule’s ability to protect cells in different clinical situations,” said Clarence Smith, President, CEO and Chairman of the Board of ProtoKinetix.
ProtoKinetix Announces Start of Phase 1 & Phase 2 Clinical Trials for the use of AAGP™ PKX-001 Treated Islet Cells in the Treatment of Type 1 Diabetes
March 9, 2017
ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) today announced the start of a Phase 1 first-in-human clinical trial of AAGP™ PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type 1 diabetes. The first patient has been treated under this protocol. 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.
To obtain additional information and updates regarding the trials please use the
following link:
https://clinicaltrials.gov/ct2/show/NCT03073577?term=pkx-001&rank=1
PKX-001 is the designation given to the drug product molecule of the AAGP™ family. Islet cell transplants are well recognized as a viable and effective treatment for Type 1 diabetes. The PKX-001 Study will treat islet cells prior to transplantation into human test subjects. The clinical trials will be assessing any side effects or physiological damage to the test subjects. The study will also be looking for indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells. The trial follows extensive preclinical evaluation in animal models.
The Phase 1 first-in-human study will evaluate the safety and tolerability of AAGP™ PKX-001 treated islets while the Phase 2 component will be evaluating the efficacy of adding AAGP™ PKX-001 treated islets to the already established Edmonton Protocol.
“If the findings translate to the clinic in a manner that reflects the preclinical studies, AAGP™ has the potential to substantially improve outcomes in patients receiving islet transplants today, and future stem cell therapies.” said 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.
Dr. James Shapiro Bio
About the Edmonton Protocol
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ProtoKinetix Updates Testing Progress on Neuronal Retinal Cells in Living Tissue for the Treatment of Macular Degeneration
2017-02-07
Company Website: http://www.protokinetix.com
ST. MARYS, W. Va. -- (Business Wire)
ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) updates its stockholders on the testing of neuronal retinal cells in living tissue at the University of British Columbia (“UBC”) under the guidance of Dr. Gregory-Evans.
As explained by Dr. Gregory-Evans, the research program at UBC will be determining whether AAGP™ can help improve the survival of stem cells that are currently being used in human trials to treat retinal blindness. We are doing this because of the poor outcome in the current state of play using stem cells in the treatment of blindness. Proof of principal work has been done in animal models but these successes are few and far between. What has been seen most recently is that probably as few as 10% of injected cells are surviving more than a week. Although this is adequate for proof of principle work, it is not good enough for developing a clinical medical treatment. We are looking for ways to improve cell survival in actual living eyes.
The researchers at UBC have reached the conclusion that AAGP™ should provide the required level of protection to ensure post-engraftment survival. One reason is theoretical and one is experimental. The theoretical basis is that when tissue is damaged, that tissue breaks down and releases toxins into its environment. We believe that AAGP™ can work to reduce the harmful effects of these toxins. Based on previous tests conducted by the Company, AAGP™ has demonstrated significant anti-inflammatory properties. The experimental basis for our hypothesis is that we have tested the drug in tissue culture in the lab and found that it improves the survival of cells.
The current work that we are doing is taking those results and that theory and looking at it now in living tissue to see if we can reproduce the successes that we achieved before. We have established a new type of model for retinal degeneration in a rabbit and are currently working on injecting neuronal cells plus AAGP™ to see if we can see any improvement long term in how these cells survive and integrate into the retina and hopefully lead to vision restoration in the animals.
“We hope to achieve results in experiments more closely aligned with human disease. If that is the case the molecule could become a major advance in the field of stem cells and blindness.” Dr. Kevin Gregory-Evans, Professor of Ophthalmology in the Faculty of Medicine, University of British Columbia
Protokinetix AAGP™ research focuses on unique healthcare solutions that can provide cell survival which prolong the life of a cell, which is crucial in many medical research and procedures done today.
- Harvesting, storage and transplanting cells, tissues and organs.
Treatments for conditions and disease caused by stress factors, including UV radiation, oxidation and inflammation
Acute medical research study is always progressing, but one of the problems that researchers rely on is the benefit from solutions that can deal with the fundamental factors of inflammation and oxidation. Both are well-known causes of life-threatening conditions and diseases, and accelerated aging. In addition many acute medical problems are benefiting from cell therapies and transplantation of cell, tissues and organs.
AAGP™ is now being used or investigated as a possible solution by many healthcare companies that specialize in medical cell therapies, organ transplant, trauma, blood product banking and anti-inflammation.
AAGP™ has taken Protokinetix's research team into preservation of stem cells and cell therapy, storage of blood platelets and blood products, harvesting and transplantation of islet cells for diabetes treatments, time sensitive organ transplantation and inflammation causing diseases and conditions.
Protokinetix expects to license several commercial applications from its AAGP™ family as well as expand its ongoing research and development with institutions and businesses. Protokinetix is actively in talks with several healthcare companies that are testing the molecule in their specific niche applications.
ProtoKinetix Announces Investigator Sponsored Human Clinical Trial Application Using AAGP™ Has Been Approved by Health Canada
January 24, 2017
ST. MARYS, W. Va.--(BUSINESS WIRE)--ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) today announced that the Governors of the University of Alberta have received a “No Objection Letter” from Health Canada to its Clinical Trial Application entitled: “Clinical Study using Antiaging Glycopeptide (PKX-001) in Islet Transplantation”. This authorization will allow the clinical trial group to enroll patients into the study. The study will test the effects of using PKX-001 (designation given to the drug product AAGP™ molecule) on islet cells treated prior to transplantation into human test subjects as an addition to the already established Edmonton Protocol for the treatment of Type 1 Diabetes.
About the Edmonton Protocol
“We have been very fortunate to have worked with ProtoKinetix on a series of highly compelling bench-top studies with their anti-aging glycopeptide compound AAGP™ in our islet research lab. Based on that data, and the early exciting finding that AAGP™ can protect human islets in a powerful way against both the stress of engraftment and toxic effects of antirejection drugs, we have now reached a pivotal step of beginning human trials in the clinic. The trial is approved and we now eagerly await the early results in patients. If the findings translate to the clinic in a manner that reflects the preclinical studies, AAGP™ has the potential to substantially improve outcomes in patients receiving islet transplants today, and future stem cell therapies.” Dr. James Shapiro, M.D., Ph.D., FRCSC, Director of Clinical Islet Transplant Program, University of Alberta.
Click for Dr. James Shapiro Bio
“This is a major milestone for ProtoKinetix as we advance our lead development program into clinic trials and affirms our ability to meet development timelines. This would not have been possible without the participation and dedication of not only our management team but also the team at the University of Alberta. My sincere thanks to them all.” Clarence Smith, President, CEO and Chairman of the Board of ProtoKinetix.
About the PKX-001 Study
PKX-001 is the designation given to the drug product molecule of the AAGP™ family. Islet cell transplants are well recognized as a viable and effective treatment for T1 diabetes. The PKX-001 Study will treat islet cells with PKX-001 prior to transplantation into human test subjects. The clinical trials will be assessing any side effects or physiological damage to the test subjects. The study will also be looking for indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells. The trail follows extensive preclinical evaluation in animal models.
ProtoKinetix, Incorporated Announces Investigator Sponsored Clinical Trial Submitted to Health Canada for the use of AAGP(TM) in the Treatment of Type 1 Diabetes
January 17, 2017
ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) today announced that the Governors of the University of Alberta have submitted an Investigational Testing Authorization application to commence clinical studies in Canada. This authorization will allow the clinical trial group to enroll Canadian patients into the study.
"Based on extensive experiments in the lab we are clearly excited to take forward the AAGP(TM) molecule from the bench to testing in patients in partnership with ProtoKinetix. This anti-aging glycopeptide molecule has been exceedingly potent in protecting human islets from early damage after transplant from engraftment and anti-rejection drugs in our preliminary tests, and if these promising findings can be replicated in patients in the clinic receiving islet cell transplants today, and potentially stem cells in the future, this would represent a major advance." Dr. James Shapiro, M.D., Ph.D., FRCSC, Director of Clinical Islet Transplant Program, University of Alberta.
Dr. James Shapiro
"It is a remarkable achievement for a small biotech company like ProtoKinetix to be submitting a Clinical Trial Application (CTA) to Health Canada." Julia Levy, PhD, Chairman ProtoKinetix Business and Scientific Advisory Board.
Dr. Julia Levy
"I look forward to the opportunity to prove that AAGP(TM), used in the Edmonton Protocol, will greatly improve results in the treatment of Type 1 Diabetes in humans. I am very pleased that we have met the goals that we set out in January, 2016." Clarence Smith, President, CEO and Chairman of the Board of ProtoKinetix.
About the PKX-001 Study
PKX-001 is the designation given to the drug product molecule of the AAGP(TM) family. Islet cell transplants are well recognized as a viable and effective treatment for T1 diabetes.
The PKX-001 Study will treat islet cells prior to transplantation into human test subjects. The clinical trials will be accessing any side effects or physiological damage to the test subjects. The study will also be looking for indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells.
ProtoKinetix, Incorporated is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP(TM)) that enhance both engraftment and protection of transplanted cells used in regenerative medicine. Due to the results achieved over the last four years of testing, the University of Alberta has submitted an Investigational Testing Authorization application to Health Canada to enter into a Phase 1/2 human clinical trial at the University of Alberta. Additional studies will be expanded to include whole organ transplantation and other cell therapies used in regenerative medicine.
ProtoKinetix, Incorporated Clarence E. Smith, 304-299-5070 President and Chief Executive Officer csmith@protokinetix.com Twitter: @ProtoKinetix
ProtoKinetix’ 2nd Quarter Scientific Update....
07/14/2016
ST. MARYS, W. Va.--(BUSINESS WIRE)--Jul. 14, 2016-- (www.protokinetix.com) is pleased to provide the following corporate update to its stockholders:
The management team has been very busy since our last update. The following is a summary of our strategy and action in support of the Company’s direction.
Clinical Trial Application progress:
1. Method Development for toxicology studies that were conducted by ITR Laboratories Canada, Inc. (ITR).
2. Method Validation for toxicology studies to be conducted by ITR has commenced.
3. Molecular study for radiation stabilization has been completed by Iotron Industries Canada, Inc. (Iotron).
4. Bio Burden testing and Bio Burden Validation testing that was conducted by Nelson Laboratories, LLC (Nelson Labs) has been completed.
5. Certificate of Analysis for Drug Substance (GMP) for AAGP™ has been completed by Ambiopharm, Inc. (Ambiopharm).
6. AAGP™ has been shipped to Iotron to complete sterilization as required by the clinical trial protocols and returned to Ambiopharm.
7. A final report of pre-transplant AAGP™ treated islet cells analysis prepared by BRI Biopharmaceutical Research, Inc. (BRI).
8. We have completed the first draft of the Investigator’s Brochure (IB), a component of the clinical trial application to Health Canada. IB is a multidisciplinary document that summarizes the main elements of an entire development program to date. Although the IB also serves other purposes, it is written to enable investigators conducting clinical trial studies to assess the risks and benefits associated with an investigational product.
We are, at present, preparing a clinical trial application to Health Canada. This trial will be conducted by the Shapiro team at the University of Alberta on the well-established, Edmonton Protocol used for treatment of Type 1 Diabetes through islet cell transplants.
Neural Stem Cell Testing:
1. Testing on stem cells transplanted in retina tissue has been completed. This study was conducted at the University of British Columbia (UBC) and directed by Dr. Kevin Gregory-Evans. Stem cells tested with AAGP™ showed a 300% increase in engraftment survival over the control group.
2. The results of Dr. Gregory-Evans’ work were published in the Journal of Tissue Engineering and Regenerative Medicine, June 2016.
3. We have commenced a major study at UBC under the direction of Dr. Gregory-Evans for the effect of AAGP™ in the transplantation of human embryonic stem cells derived from neuronal type cells. This research holds significant potential for the treatment of conditions where neuronal cell death or damage has occurred. This includes age-related macular degeneration (AMD), stroke and spinal cord injury.
“I am extremely proud of how much we have accomplished in these last six months. I look forward to the future for this company that holds so much potential. I am grateful to all of those who have been involved in our progress.”-Mr. Clarence Smith.
We are looking forward to moving ahead with our application for clinical trials this year. We anticipate testing on the effects of AAGP™ on the preservation of whole donor organs and tissues for transplantation. We remain very confident in our strategy and appreciate your support of our actions to develop life-saving treatments for disease worldwide and to maximize financial returns to you, our stockholders and friends.
ProtoKinetix, Incorporated is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that enhance both engraftment and protection of transplanted cells used in regenerative medicine. Due to the results achieved over the last four years of testing the company is now preparing a submission to enter into a Phase 1/2 human clinical trial at the University of Alberta. Additional studies will be expanded to include whole organ transplantation and other cell therapies used in regenerative medicine.
ProtoKinetix’ AAGP™ has been Published in the Journal of Tissue Engineering and Regenerative Medicine
06/07/2016 - Business Wire
ST. MARYS, W.Va.--(BUSINESS WIRE)--Jun. 7, 2016-- ProtoKinetix, Incorporated (OTCQB:PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to announce that a paper submitted by Dr. Kevin Gregory-Evans on ProtoKinetix’ AAGP™ has been published in the Journal of Tissue Engineering and Regenerative Medicine and is available online at:
Anti-ageing glycoprotein promotes long-term survival of transplanted neurosensory precursor cells
AAGP™, an antifreeze glycopeptide, has been demonstrated to significantly improve the viable yield of stem cells transplanted in retinal tissue at the University of British Columbia under the guidance of Dr. Kevin Gregory-Evans.
ProtoKinetix has entered into a research agreement with the University of British Columbia to research neuronal cell transplantation as an extension of the studies recently published by Dr. Gregory-Evans in the Journal of Tissue Engineering and Regenerative Medicine.
Regarding the new studies, IN VIVO STUDIES TO DETERMINE THE POTENTIAL OF ANTI-AGING GLYCOPROTEIN (AAGP™) IN ENHANCING THE LONGTERM SURVIVAL OF NEURAL STEM CELLS, Dr. Gregory-Evans explains: “My research team at the University of British Columbia is very excited to move on to the next stage of our studies with ProtoKinetix’ compound AAGP™. We have shown that it is useful, in a simple model system, at promoting stem cell survival in tissue transplantation experiments. The next stage is now to move into animal model systems. This is for three reasons, first because it will give us a better quantitative understanding of AAGPs™ effectiveness, that is not only will it show us if AAGP™ works but also how well in might work in humans. Second, it will show us if there are any toxicity concerns in our target tissue (the central nervous system) and third as a regulatory requirement before undertaking human studies. Our major interest is blinding eye disease and stroke. We will study AAGP™ in models of both these common central nervous system ailments with the hope that, all going well, we can move on to early clinical studies in human sufferers within the next five years. Tissue transplantation promises to revolutionize the medicine of tomorrow and we think AAGP™ will be an important part of this revolution.”
ProtoKinetix is also pleased to report that it has received the assignment of the patents for the use of AAGP™ in retinal cell transplantation.
Journal of Tissue Engineering and Regenerative Medicine is a multidisciplinary journal that publishes research and reviews on the development of therapeutic approaches which combine stem/progenitor cells with biomaterials and scaffolds, and growth factors and other bioactive agents. The journal focuses on the development of biological functional substitutes that restore, maintain, or improve tissue or organ function. The publication carries an Impact Factor of 5.199.
ProtoKinetix, Incorporated is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that enhance both engraftment and protection of transplanted cells used in regenerative medicine. Due to the results achieved over the last four years of testing the company is now preparing a submission to enter into a Phase 1/2 human clinical trial at the University of Alberta. Additional studies will be expanded to include whole organ transplantation and other cell therapies used in regenerative medicine.
AAGP™ Improves Results in Stem Cells Transplanted in Retina Tissue by 300%
05/02/2016 - Business Wire
ST. MARYS, W.Va.--(BUSINESS WIRE)--May 2, 2016-- ProtoKinetix, Incorporated (OTCQB:PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to announce that a paper submitted by Dr. Kevin Gregory-Evans on ProtoKinetix’ AAGP™ has been accepted by the Journal of Tissue Engineering and Regenerative Medicine for publication. The date of publication is unknown at this time but should be available online in advance of the printed version. AAGP™, an antifreeze glycopeptide, has been demonstrated to significantly improve the viable yield of stem cells transplanted in retinal tissue at the University of British Columbia under the guidance of Dr. Kevin Gregory-Evans.
Dr. Gregory-Evans concluded that embryonic cells treated with AAGP™ and transplanted into retina tissue, an accepted model for the central nervous system, compared to the control group not treated was 300% more viable.
Dr. Gregory-Evans proposes that AAGP™ works by inhibiting toxic signaling from surrounding necrotic tissue. Necrotic tissue is dead tissue, which usually results from an inadequate local blood supply. Necrotic tissue contains dead cells and debris that are a consequence of the fragmentation of dying cells.
”AAGP™ could be a huge benefit to the future of Pre-clinical and Clinical transplantation medicine,”said Dr. Kevin Gregory-Evans. He added,“AAGP™ will revolutionize transplantation medicine across the board.”
The significance of these results may have far reaching implications. In addition to cell, tissue and organ transplantations, there are strong implications that AAGP™ may have powerful applications for the treatment of stroke and heart attack treatment.
Dr. Kevin Gregory-Evans is currently Professor of Ophthalmology in the Faculty of Medicine, University of British Columbia, and holder of the Julia Levy BC Leadership Chair in Macular Research, Vancouver, Canada.
Dr. Gregory Evans' Bio is too extensive to repeat in full on this press release-his full Bio can be found at: http://protokinetix.com/about/kevin-gregory-evans/.
Journal of Tissue Engineering and Regenerative Medicine is a multidisciplinary journal that publishes research and reviews on the development of therapeutic approaches which combine stem/progenitor cells with biomaterials and scaffolds, and growth factors and other bioactive agents. The journal focuses on the development of biological functional substitutes that restore, maintain, or improve tissue or organ function. The publication carries an Impact Factor of 5.199.
ProtoKinetix, Incorporated is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that enhance both engraftment and protection of transplanted cells used in regenerative medicine. Due to the results achieved over the last four years of testing the company is now preparing a submission to enter into a Phase 1/2 human clinical trial. Additional studies will be expanded to include whole organ transplantation and other cell therapies used in regenerative medicine.
ProtoKinetix Outlines Steps to Clinical Trial Application for AAGP™
04/26/2016
ST. MARYS, W.Va.--(BUSINESS WIRE)--Apr. 26, 2016-- ProtoKinetix, Incorporated (OTCQB: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) outlines the steps to be completed for the application to conduct a clinical trial in Canada.
For the last four years ProtoKinetix has been involved in a collaboration with the Laboratory of Dr. James Shapiro, M.D., Ph.D., FRCSC, the director of the Clinical Islet Transplant Program at the University of Alberta Hospital. The outcome of these extensive tests resulted in a publication this February in the prestigious American Diabetes Association Journal, Diabetes and a planned submission to Health Canada of a clinical trial application (CTA). The CTA, for a Phase 1/2 study in patients, will involve the addition of AAGP™ to the well-established Edmonton Protocol for islet cell transplants for the treatment of type 1 diabetes.
Before a CTA can be submitted several rigorous tests and events have to be completed.
1. The molecule being tested has to be produced under current Good Manufacturing Practice (GMP) guidelines. GMP is an exacting standard of production that requires a validated and documented approach for each step of the process and a complete provenance for every component.
2. A Pharmacokinetic (PK) analysis with a validated methodology has to be completed on the molecule to determine AAGP™’s absorption and distribution throughout the human body.
3. The molecule has to be tested for toxicology, including evaluation of the genotoxic potential.
4. The end product must be certified as sterile.
5. An Investigator's Brochure has to be prepared incorporating these results as well as the Chemistry, Manufacturing, & Control (CMC) documentation provided by the GMP facility.
The CTA submission will be an Investigator-sponsored application from Dr. James Shapiro’s Laboratory.
In order to assist the Company in achieving a cost effective and timely CTA submission, ProtoKinetix has retained the services of the following experts and Contract Research Organizations (CROs):
Evelina Rubinchik PhD
Dr. Rubinchik is our contracted toxicologist who is organizing theselection of nonclinical CROs and management of toxicological studies. Dr. Rubinchik is also involved in the preparation of project budgets and timelines, review, and interpretation of toxicological data.
Dana Nohynek MSc, RAC
Ms. Nohynek is an independent regulatory consultant with expertise in Clinical Trial Application submissions and liaising with the Canadian regulatory authority.
PK Analysis CRO
BRI Biopharmaceutical Research Inc. is a specialized analytical, LC/MS/MS bioanalytical and DM/PK contract research organization (CRO) servicing pharmaceutical and biotechnology companies in discovery, preclinical and clinical programs supporting IND and Toxicology CROs.
Toxicology CRO
ITR Canada Inc. is an international contract research organization that provides non-clinical toxicology services for the biotechnology and pharmaceutical industries with clients located around the globe. Operating in Montréal since 1989, ITR’s purpose-built preclinical research facility was designed to be optimized for quality technical and scientific research. A privately-held organization with more than 300 employees in Canada, ITR offers personalized services from planning and study program design to study implementation and reporting for regulatory drug filing. ITR Canada is CCAC and AAALAC accredited, and studies conducted are fully compliant with GLP.
Manufacturing CRO
AmbioPharm, Inc. (APi) is a full-service peptide manufacturing company headquartered in North Augusta, SC, USA. In its cGMP manufacturing facilities in the USA and Shanghai, China, it develops highly efficient processes for manufacturing peptides at small to very large scale as Active Pharmaceutical Ingredients used in New Chemical Entities and generic peptides by clients worldwide.
ProtoKinetix Corporate Update..
Jan. 5, 2016
ST. MARYS, W. Va.--(BUSINESS WIRE)--Jan. 5, 2016-- ProtoKinetix, Incorporated (OTCQB:PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to provide the following corporate update to its stockholders:
Fiscal 2015 was a year of significant progress for ProtoKinetix, Incorporated. We executed several complex initiatives and continued to make great strides in delivering the strategic initiatives to improve the fiscal health of the Company and to further the scientific advancement of the AAGP™ molecule. Overall, the company’s regulatory status, financial position and scientific foundation for commercial growth are all stronger today than they were a year ago.
Our company has recently been restructured to improve efficiency and to enable growth and value to our stockholders. We have a new management team comprised of some old and some new faces. The team members are:
Clarence E. Smith President and CEO
Susan M. Woodward, CFO
Edward P. McDonough, Director and Head of Audit Committee
Peter Jensen, Head Consultant Business Advisory Board
Julia Levy, Head Consultant Scientific Board
Grant Young, Head Consultant Research and Development
The financial position of ProtoKinetix has never been stronger. Since June of 2014 all past overdue filings with the Securities Exchange Commission have been brought up to date. We received a Full Revocation Order on February 23, 2015 from the British Columbia Securities Commission in regards to its previously implemented Cease Trade Order issued on May 9, 2013. During this time period, ProtoKinetix negotiated a debt settlement with Standard Bankcorp resulting in a gain on settlement of $192,000.
All US tax returns have been filed from 1999 to 2014 and ProtoKinetix has been accepted to both the Offshore Voluntary Disclosure Program and the Domestic Voluntary Disclosure Program to comply with US tax law.
As of June 8th, ProtoKinetix began trading on the OTCQB® Venture Marketplace under the symbol "PKTX." The Company was formerly trading on the OTC Pink® marketplace under the same symbol.
We were pleased to acquire a portion of certain patents and all rights associated therewith from the University of Alberta pursuant to a Royalty Agreement entered into on or about April 8, 2015.
ProtoKinetix has had positive changes to our Balance Sheet as follows:
| Account | | | Balance 12/31/14 | | | ProjectedBalance12/31/15 | | | Change |
| Cash | | | 317 | | | 360,000 | | | 359,683 |
| Debt | | | 818,143 | | | 135,000 | | | (683,143) |
| Shares | | | 175,662,433 | | | 216,602,433 | | | 40,940,000 |
| Assets | | | | | | 65,000 | | | 65,000 |
Our cash position increased by $359,683 due to an increase in private placements. Debt decreased by $683,143 due to settlement of all long and short term debts. We issued 40,940,000 shares of our common stock in connection with private placements, consulting agreements and settlement of debt. Assets increased by $65,000 due to the acquisition of patents.
Our CFO, Susan M. Woodward noted, “During this current year we have made great strides in placing ProtoKinetix to be in a much more favorable position to allow the Company to move forward and keep stride with the blossoming scientific advances of our AAGP™ molecule. I look forward to our continued success in 2016 with the support of our current and future stockholders as well as the dedication of our management and consulting team.”
This year ProtoKinetix had notable achievements of which we are very proud. AAGP™ was presented at the Congress of the International Pancreas and Islet Transplant Association in Melbourne, Australia in November. We also completed an intense, 3-year islet transplantation study with the University of Alberta. Currently, we have completed a peer review and have been published in the prestigious, American Diabetes Association’s Journal: Diabetes. We are continuing to study the effects of AAGP™ on Non-Obese Diabetic mice at the Dr. James Shapiro Lab in Edmonton at the University of Alberta.
We are, at present, preparing a clinical trial application to Health Canada. This trial will be conducted by the Shapiro team at the University of Alberta on the well-established, Edmonton Protocol used for treatment of Type 1 Diabetes through islet cell transplants.
As part of this submission, the company has:
Commissioned AmbioPharm, Inc. to produce AAGP™ under strict GMP (Good Manufacturing Practice) standards. GMP is required by Health Canada and US FDA (United States Food and Drug Administration) for human use. Toxicity testing will be conducted by a third party. Pharmacokinetics and Pharmacodynamics (PK/PD) has been addressed by BRI Labs in Vancouver. PK/PD studies the absorption rate and quantities of drugs through the human body. We are looking forward to moving ahead with our application for clinical trials in the coming year. We anticipate testing on the effects of this molecule on the preservation of whole donor organs and tissues for transplantation.
In closing, I want to thank our Board of Directors, the Business and Scientific Advisory Board and the rest of the ProtoKinetix team, whose creativity, hard work and dedication have made this year’s achievements possible. Our strong relationship with Dr. James Shapiro and his scientific team continues to be a key asset in following our path to commercialization. We have a unique opportunity to make a difference and we are well prepared to meet our corporate needs for 2016 and pursue continued growth and maximize stockholder value.
AAGP Found to Significantly Improve Islet Cell Transplantation in Type 1 Diabetes Patients
Dec 17, 2015
ST. MARYS, W. Va. -- (Business Wire) --
ProtoKinetix, Incorporated (OTCQB:PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to announce that their molecule, AAGP, an antifreeze glycopeptide that mimics a naturally occurring glycoprotein found in Arctic fish is helping to significantly improve the efficacy of Cell Transplant Treatments for diabetes - a procedure that transplants insulin producing islet to render them insulin independent for periods of time.
Anti-Aging GlycoPeptide (AAGP), is the focus of a new study published in the journal Diabetes. Researchers from the University of Alberta's Faculty of Medicine & Dentistry found that by soaking islet cells in AAGP for an hour and then washing it off prior to transplantation, the cells were protected from tacrolimus an antirejection drug commonly used during transplants that is toxic to islets cells.
Normally when we expose human islets to tacrolimus in the petri dish, they flat line and don?t release insulin at all, says James Shapiro, senior author of the study and Canada Research Chair in Transplant Surgery and Regenerative Medicine at the U of A. When we add the AAGP and wash it all off, the cells work perfectly normally, and are protected in a remarkably durable manner. We find we need far fewer cells to treat diabetes in our preclinical models than we would normally.
Since his creation of the Edmonton Protocol in 1999, more than 250 patients have been treated by Shapiro through islet cell transplantation. A key challenge of the procedure though is that most patients typically need two islet infusions, each prepared from a separate pancreas organ donor. Shapiro says there aren't enough organ donors to meet demand. Through the use AAGP, a greater number of islet cells will survive the procedure, potentially allowing more patients to be treated.
Just a one hour soak in AAGP is enough to protect the islet cells for up to a month or two afterwards. It has a very potent and profound effect, says Shapiro. As a direct result of these findings, we're now moving forward with plans for a first in human clinical trial?led at the University of Alberta?testing this drug in our human islet cell transplant program.?
This synthetic molecule seems to provide significant protection to cells exposed to multiple deleterious conditions, such as UV radiation, starvation, extreme temperatures andoxidative stress, says Boris Gala-Lopez, lead author of the study and a clinical/research fellow at the U of A's Department of Surgery. We are certainly very excited for the multiple opportunities this finding entails to the field of transplantation research.
Funding for the study was provided by the Diabetes Research Institute Foundation of Canada, while the drug AAGP was provided by ProtoKinetix.
We are very excited to have our AAGP molecule showcased in this prestigious journal. We are also extremely confident in the ongoing success of our collaboration with Dr. James Shapiro and his outstanding team said Clarence Smith, President, CEO and Chairman of the Board of ProtoKinetix.
If proven successful in human clinical trials, Shapiro believes the inclusion of AAGP could soon become a permanent addition to the Edmonton Protocol representing a significant step forward in the treatment of Type 1 diabetes through islet transplantation. While more research is needed, he also believes the drug shows promise for a wide range of transplantations?potentially working to protect organs as effectively as it protects islets.
ProtoKinetix’ AAGP™ to Be Presented at the Congress of the International Pancreas and Islet Transplant Associatio
09/10/2015
ST. MARYS, W. Va.--(BUSINESS WIRE)--Sep. 10, 2015-- ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to announce that AAGP™ will be presented at the 2015 Joint Congress of the IPITA-IXA-CTS onMonday, November 16, 2015.The Joint Congress of the International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation Association (IXA) and the Cell Transplant Society (CTS) to be held in Melbourne, Australia, 15–19 November 2015.
Dr. Boris L. Gala-Lopez, Research Fellow of Department of Surgery in the Alberta Diabetes Institute at the University of Alberta will be giving a lecture titled “Anti-aging Glycopeptide Protects Human Islets Against Tacrolimus-related Injury and Facilitates Engraftment” to support his conclusion that, “Supplementation with AAGP™ during the culture period improves islet quality and potency. Upon transplantation, pre-treatment with AAGP™ may facilitate engraftment in mice, improve graft secretory function and may attenuate long-term tacrolimus induced graft dysfunction. These findings may constitute a clear opportunity to develop more efficient strategies against post-transplant diabetes mellitus.”
For details see the web site: confman.melbourne2015.org/mobis/lecture/758
About Dr. Boris L. Gala-Lopez
Dr. Gala-Lopez is currently a PhD Research Fellow in the Clinical Islet Transplant Program at the University of Alberta. He has been responsible for multiple preclinical and clinical investigations in the field of islet transplantation to improve the novel treatment for Type 1 diabetes mellitus.
Dr. Gala-Lopez has also done extensive work in the area of ischemia-reperfusion injury for cell and solid organ transplantation.
ProtoKinetix Begins Testing Diabetic Mice with AAGP™ at the University of Alberta..
09/18/2015
ST. MARYS, W. Va.--(BUSINESS WIRE)--Sep. 18, 2015-- ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to announce that it has begun testing NOD (Non Obese Diabetic) mice with its AAGP™ molecule at the James Shapiro laboratory at the University of Alberta.
Type 1, diabetic NOD mice with AAGP™ versus a control group of Type 1, diabetic NOD mice without AAGP™ will be monitored for their blood-glucose levels. Using the NOD mice as a model the Edmonton team will be specifically assessing the potentially protective effect of AAGP™ against the antibody attack conducted against the islet cells in the pancreas.
NOD Mice, like the Bio-Breeding rat, are used as an animal model for Type 1 diabetes. Non-obese diabetic (NOD) mice exhibit a susceptibility to spontaneous development of autoimmune insulin dependent diabetes mellitus (IDDM).The NOD strain and related strains were developed at Shionogi Research Laboratories in Aburahi, Japan by Makino and colleagues and first reported in 1980.The group developed the NOD strain by an outbreeding of the cataract-prone strain from JcI:ICR mice.
At the conclusion of these tests, the internal organs of the NOD mice will be examined for any evidence of toxicity and bioavailability. This data is an extremely valuable step on the critical path towards submissions to Health Canada or the FDA for human clinical trial applications.
About the James Shapiro Laboratory
The James Shapiro Laboratory is active experimental laboratory working on improving long term survival of transplanted islets, and in immunomodulation of transplanted tissues. He is Principal Investigator on several NIH and JDRF-funded clinical trials, including clinical testing of costimulation blockade in islet transplantation.
About ProtoKinetix
ProtoKinetix, Inc. is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that enhance therapeutic results and reduce the cost of stem cell medicine. Due to the anti-inflammatory effect of AAGP™ molecules, the Company is currently targeting the direct treatment of diseases that have a major inflammatory component.
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Some information included in this press release may contain statements that are forward-looking. Such forward-looking information involves significant risks and uncertainties that could affect anticipated results in the future and, accordingly, these results may differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. For a description of additional risks and uncertainties, please refer to the Company’s filings with the Securities and Exchange Commission.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150918005068/en/
Source: ProtoKinetix, Inc.
ProtoKinetix, Inc.Clarence E. Smith, President & Chief Executive Officer304-299-5070csmith@protokinetix.com
***PKTX...ProtoKinetix Reports on Its Strong Collaboration with the James Shapiro Laboratory at the University of Alberta
August 4, 2015
***ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to report on its collaboration with the James Shapiro laboratory at the University of Alberta. The sole intention of the collaboration is to develop a commercial product pipeline of therapeutic applications for the AAGP™ family of molecules.
...Professor James Shapiro is Professor of Surgery, Medicine and Surgical Oncology, and Director of the Clinical Islet Transplant Program and the Living Donor Liver Transplant Program at the University of Alberta in Edmonton, Canada. He has a busy hepatobiliary surgical practice in HPB oncology, and in liver and kidney-pancreas transplant surgery. His center carries out 80 liver transplants per year, and has done around 80 living donor liver transplants. The University of Alberta just celebrated their 1000th liver transplant.
...Dr. Shapiro directs the largest clinical islet transplant program worldwide with almost 170 patients treated, and led the clinical team that developed the "Edmonton Protocol" - the first trial to achieve consistent 100% insulin independence in a series of islet-alone transplant recipients with Type 1 diabetes (published in the NEJM 2000). Before Dr. Shapiro’s trial, the success rate with islet transplantation was less than 8%. He led an international multicenter trial to replicate these findings in 9 international centers (published in NEJM 2006).
...Over the last 32 months Dr. Shapiro and his team have been extensively testing the AAGP™ molecule in allogeneic transplants using human islet cells as the model. As regenerative medicine is rapidly becoming adopted in the treatment of degenerative diseases, the protection of the transplanted cells, tissues, and organs is of paramount importance. Transplanted cells and tissues are subjected to extreme stress factors that, unless protected, could cause failure to graft or premature death. The success of the tests conducted in Edmonton have demonstrated that AAGP™ has the potential to be widely adopted in many areas of regenerative medicine.
.."I'm very excited about our ongoing collaborations with PKTX and by the remarkable potency of AAGP. This molecule has great potential, and we are just beginning to scratch beneath the surface," said Dr. James Shapiro.
...As a result of the tests, Dr. Shapiro and his team are developing further testing based on three primary activities:
..1. The ongoing testing and refinement of cellular transplantation using human islet cells as the demonstrated model. In particular, AAGP™ may provide powerful protection against hostile agents that severely inhibit engraftment success. Cell therapies are currently being developed around the world for the treatment of spinal cord injury, damaged heart tissue, stroke, diabetes as well as many other conditions.
..2. Human organ preservation. The program will assess the effect of AAGP™ in extending the transplant viability of donor organs. The Canadian National Transplant Research Program is a major national initiative involving the Federal institutes of health, all Provinces and the private sector. http://www.cntrp.ca/. The first testing will be conducted on livers to determine whether AAGP™ can extend the ex-vivo functionality of the organ.
..3. Auto immune disease. This class of diseases occur where the body's immune system starts to attack healthy cells. Diseases in this category include, rheumatoid arthritis, multiple sclerosis and Type 1 diabetes. Using the NOD (Non Obese Diabetic) mice as a model the Edmonton team will be specifically assessing the potentially protective effect of AAGP™ against the antibody attack conducted against the islet cells in the pancreas.
...“This impressive team of transplant surgeons and scientists have made clear to us the dramatic scope of applications that our family of molecules possesses,” said Clarence Smith, President, CEO and Chairman of the Board of ProtoKinetix.
.....About the James Shapiro Laboratory
The James Shapiro Laboratory is active experimental laboratory working on improving long term survival of transplanted islets, and in immunomodulation of transplanted tissues. He is Principal Investigator on several NIH and JDRF-funded clinical trials, including clinical testing of costimulation blockade in islet transplantation.
**PKTX.. ProtoKinetix Upgrades to OTCQB... OFF of Pinks..!
June 8, 2015
...ProtoKinetix, Incorporated (OTCQB: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to announce that ProtoKinetix began trading today on the OTCQB(R) Venture Marketplace under the symbol "PKTX." The Company was formerly trading on the OTC Pink(R) marketplace under the same symbol.
U.S. investors can find current financial disclosure and Real-Time Level 2 quotes for the Company at: http://www.otcmarkets.com/stock/PKTX/quote.
"After considerable effort and significant investment in our public disclosure, we are proud to be trading on the OTCQB marketplace. This upgrade should broaden our shareholder base, improve liquidity and increase the visibility for our achievements going forward," said Clarence E. Smith, President and Chief Executive Officer of ProtoKinetix.
The OTCQB Venture Marketplace offers transparent trading in entrepreneurial and development stage U.S. and international companies. To be eligible, companies must be current in their financial reporting and must undergo an annual verification and management certification process. Companies must also meet a minimum one penny bid test and may not be in bankruptcy.
About ProtoKinetix
ProtoKinetix, Inc. (OTCQB: PKTX) is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP(TM)) that enhance the therapeutic results and reduce the cost of stem cell medicine. Due to the anti-inflammatory effect of AAGP(TM) molecules, the Company is currently targeting the direct treatment of diseases that have a major inflammatory component.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Some information included in this press release contains statements that are forward-looking. Such forward-looking information involves significant risks and uncertainties that could affect anticipated results in the future and, accordingly, these results may differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. For a description of additional risks and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission.
Clarence E. Smith -- President and CEO
**PKTX..CEO Clarence Smith Reports on Edmonton Meetings with Dr. James Shapiro and his Team...
06/05/2015
ST. MARYS, W.Va.--(BUSINESS WIRE)--Jun. 5, 2015-- ProtoKinetix, Incorporated(OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to announce that CEO Clarence Smith recently returned from visiting Dr. James Shapiro at the University of Alberta. Mr. Smith met with Dr. Shapiro and his impressive team, including Dr. Boris Gala-Lopez. As previously announced, the Company has been heavily involved with the James Shapiro Laboratory for the last 24-months. Dr. Shapiro’s team has conducted extensive tests on islet cell transplantation using the AAGP™ molecule for the treatment of diabetes using AAGP™. Mr. Smith was impressed with the program and gratified that AAGP™ was proving to be a central element in the research.
Dr. Shapiro is a professor of surgery, medicine and surgical oncology. He is director of the Clinical Islet Transplant Program and the Living Donor Liver Transplant Programs at the University of Alberta. He is also principal investigator of National Institute of Health and the Juvenile Diabetes Research Foundation clinical trials. In addition to these positions, he is the leader of the Project 1 - Ex-vivo Organ Transplant Protection and Repair Program of the Canadian National Transplant Research Program.
Due to the excellent results of these tests on islet cell transplantation with AAGP™, Dr. Shapiro and his team are expanding their field of investigation to include:
1) Whole Organ Preservation
a. A major initiative of the Canadian National Transplant Research Program (CNTRP).
b. Preservation of hearts, lungs, kidneys, livers and transplantable tissue has become of critical importance to transplantation medicine.
2) Non Obese Diabetes (NOD) Mice
a. NOD mice are used as an animal model for Type 1 Diabetes testing.
b. Dr. Shapiro’s team shall be exploring the potential of AAGP™ to delay the progression of this disease.
“This impressive team of transplant surgeons and scientists have made clear to me the dramatic scope of applications that our family of molecules possess,” said Clarence E. Smith, President and Chief Executive Officer.
About ProtoKinetix
ProtoKinetix, Inc. is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that enhance the therapeutic results and reduce the cost of stem cell medicine. Due to the anti-inflammatory effect of AAGP™ molecules, the Company is currently targeting the direct treatment of diseases that have a major inflammatory component.
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Some information included in this press release contains statements that are forward-looking. Such forward-looking information involves significant risks and uncertainties that could affect anticipated results in the future and, accordingly, these results may differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. For a description of additional risks and uncertainties, please refer to the Company’s filings with the Securities and Exchange Commission.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150605005032/en/
Source: ProtoKinetix, Inc.
ProtoKinetix, Inc.Clarence E. Smith, 304-299-5070President and CEO
***University of Alberta...Acquisition of Patent....
***ProtoKinetix Announces Acquisition of Patents..
04/14/2015
ST. MARYS, W. Va.--(BUSINESS WIRE)--Apr. 14, 2015-- ProtoKinetix, Incorporated (OTC: PKTX) (www.protokinetix.com) (“ProtoKinetix” or the “Company”) is pleased to announce that it has completed the acquisition of a portion of certain patents and all rights associated therewith (the “Patent Rights”) from the University of Alberta (“UAB”) pursuant to a Royalty Agreement (the “Agreement”) entered into on or about April 8, 2015.
The Agreement also grants UAB a royalty of 5% of the gross revenue from the assignment, manufacturing, sale, distribution, or licensing of the Patent Rights and any commercial products generated from the Patent Rights. The Company has the irrevocable option to purchase the royalty for CAN $5,000,000 (approximately US $4,000,000) for two years from the earlier of the first date UAB publishes its research related to the Patent Rights or September 1, 2015.
Through this assignment, the Company has gained UAB’s portion of US provisional patent application no. 62/007,626 related to the use of anti-aging glycopeptides to enhance beta cell health, survival and improve transplant outcomes, and all patents issuing from and claiming priority to such application.
About ProtoKinetix
ProtoKinetix, Inc. is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that dramatically enhance therapeutic results and reduce the cost of stem cell medicine. Due to the anti-inflammatory effect of AAGP™ molecules, the Company is currently targeting the direct treatment of diseases that have a major inflammatory component.
Cautionary Statement Regarding Forward-Looking Information
Except for statements of historical fact, this news release contains certain “forward-looking information” within the meaning of applicable securities law, including statements regarding the Company's intention to license the Patent rights to third parties and the potential treatments for which the Company's AAGPTM may be applied. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements.The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements.More detailed information about potential factors that could affect financial results is included in the documents filed by the Company from time to time with the United States Securities Commission and with securities regulatory authorities in Canadian on SEDAR.
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Some information included in this press release contains statements that are forward-looking. Such forward-looking information involves significant risks and uncertainties that could affect anticipated results in the future and, accordingly, these results may differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. For a description of additional risks and uncertainties, please refer to the Company’s filings with the Securities and Exchange Commission.
Clarence E. Smith –President and CEO
Source: ProtoKinetix, Inc.
ProtoKinetix, Inc.Clarence E. Smith, President & Chief Executive Officer304-299-5070csmith@protokinetix.com
***ProtoKinetix Announces Acquisition of Patents
Apr. 7, 2015
...ProtoKinetix, Incorporated (OTC: PKTX) (www.protokinetix.com) (“ProtoKinetix” or the “Company”) is pleased to announce that it has completed the acquisition of certain patents and all rights associated therewith (the “Patents”) from Institut National des Sciences Appliquées de Rouen (“INSA”) pursuant to an Assignment of Patents and Patent Application (the “Patent Assignment”) entered into on or about January 5, 2015.
ProtoKinetix made payment of 25,000 Euros to INSA for all of the Patents and rights associated therewith, for the “Gem difluorinated C-glycopeptides, their preparation and their use for the preservation of biological materials and/or in cryosurgery” family of patents, which includes issued patents in Canada (Patent No. CA2,558,801), England, France, and Germany (Patent No. EP1,817,329) and the United-States (Patent No. US8,394,362). These Patents secure, amongst other things, key intellectual property rights to the Company’s AAGP™ lead compound.
By securing these Patents, the Company is in a better position to move forward with its operations. “We are pleased to secure the rights to these Patents as we can now license the rights to other companies to develop different applications of the AAGP™ lead compound,” said Clarence E. Smith, President and Chief Executive Officer.
About ProtoKinetix
ProtoKinetix, Inc. is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that dramatically enhance therapeutic results and reduce the cost of stem cell medicine. Due to the anti-inflammatory effect of AAGP™ molecules, the Company is currently targeting the direct treatment of diseases that have a major inflammatory component.
Cautionary Statement Regarding Forward-Looking Information
Except for statements of historical fact, this news release contains certain “forward-looking information” within the meaning of applicable securities law, including statements regarding the Company's intention to license the Patent rights to third parties and the potential treatments for which the Company's AAGPTM may be applied. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements.The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements.More detailed information about potential factors that could affect financial results is included in the documents filed by the Company from time to time with the United States Securities Commission and with securities regulatory authorities in Canadian on SEDAR.
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Some information included in this press release contains statements that are forward-looking. Such forward-looking information involves significant risks and uncertainties that could affect anticipated results in the future and, accordingly, these results may differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. For a description of additional risks and uncertainties, please refer to the Company’s filings with the Securities and Exchange Commission.
Clarence E. Smith –President and CEO
Source: ProtoKinetix, Inc.
ProtoKinetix, Inc.Clarence E. Smith, President & Chief Executive Officer304-299-5070csmith@protokinetix.com
***University of Alberta Diabetes Institute Encouraged by Preliminary Results of Testing of ProtoKinetix Licensed AAGP™ Molecule in Islet Cell Transplantation
Mar. 26, 2015
...ProtoKinetix (OTC: PKTX) (www.protokinetix.com) is pleased to be able to report a comprehensive transplantation testing program being conducted for the last two years in conjunction with the University of Alberta transplant research team. The Company is collaborating with the James Shapiro Laboratory at the University of Alberta in Edmonton, Alberta. Dr. Shapiro directs the largest clinical islet transplantation program in the world.
Dr. Shapiro is a professor of surgery, medicine and surgical oncology. He is director of the Clinical Islet Transplant Program and the Living Donor Liver Transplant Programs at the University of Alberta. He is also principal investigator of National Institute of Health and the Juvenile Diabetes Research Foundation clinical trials. In addition to these positions, he is the leader of the Project 1 - Ex-vivo Organ Transplant Protection and Repair Program of the Canadian National Transplant Research Program.
During the last 24-months, Dr. Shapiro’s Ph.D. student, Dr Boris Gala-Lopez, and his team have conducted extensive testing with our AAGP™ molecule using human islet cells in transplantation, investigating its effect on engraftment, insulin production, protective effect against anti-rejection drugs and investigation of the mechanism of action. The results provided consistent encouragement to continue testing to develop protocols that can be applied to transplantation medicine.
Allogeneic transplantation is the transplanting of cells, tissues or organs from the same species, but not with the host DNA. Serious issues that have to be addressed are the engraftment of the transplanted organ or cells and the subsequent protection against the immune response. The protection, in the form of anti-rejection drugs, is toxic and causes damage to the graft. AAGP™ has been shown in these trials to increase engraftment and reduce the toxicity damage.
Dr. Shapiro says “We are all very encouraged by the early results of these studies, and I look forward to working with the Company in moving toward use of AAGP™ in future clinical applications”.
****Dr. Julia Levy Accepts Position on ProtoKinetix’ Business and Scientific Advisory Board
Feb. 26, 2015
...ProtoKinetix (OTCQB:PKTX) (www.protokinetix.com) is pleased to announce that Julia Levy, PhD, co-founder of QLT, Inc., has accepted the position as head of its Business and Scientific Advisory Board. ....Discoveries made by her and colleagues at the University of British Columbia in the field of photodynamic therapy were the basis of the first medical treatment of macular degeneration, a leading cause of blindness among the elderly, a treatment was developed by QLT, Inc. She served first as Chief Scientific Officer and later as Chief Executive Officer of QLT. Dr. Levy is an officer of the Order of Canada and has received a number of honorary degrees. She has served on the boards of a number of companies as well as of charitable organizations.
As ProtoKinetix continues to grow and to make the important transition to becoming a full-fledged clinical stage company, Dr. Levy’s in-depth experience and understanding of both the regulatory and business aspects of the biopharmaceutical industry are particularly valuable for the expansion and commercialization of AAGP™ applications.
About Dr. Levy
As co-inventor of Visudyne and co-founder of QLT, Dr. Levy served in several key senior positions at the company including Chief Scientific Officer as well as President and CEO. Under Dr. Levy’s leadership, QLT recorded the strongest period of growth in the company’s history and earned a reputation for achieving milestones, including FDA approval for Visudyne to treat age-related macular degeneration, the commonest cause of severe vision loss in the elderly. Dr. Levy has earned numerous awards and honours including an appointment as an Officer of the Order of Canada, the Female Entrepreneur of the Year for International Business, Pacific Canada Entrepreneur of the Year and the Future of Vision Award from the Foundation Fighting Blindness. In 2002 she received, along with Dr. David Dolphin, the Friesen-Rygiel prize for medical research and the Prix Galien Canada research award. In her honour, the Julia G. Levy Professorship in Ophthalmology Chair was created at Johns Hopkins Hospital Wilmer Eye Institute in 2004, the same year she was awarded the Lifetime Achievement Award from the BC Biotechnology Association. In 2009, the province of British Columbia permanently endowed the Julia Levy B.C. Leadership Chair in Macular Research at the University of British Columbia (U.B.C.) in partnership with U.B.C. and QLT.
About ProtoKinetix
ProtoKinetix, Inc. is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™). These molecules have been demonstrated to protect cells against hostile conditions that are present in all areas of transplantation including regenerative medicine.
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Some information included in this press release contains statements that areforward-looking. Such forward-looking information involves significant risks and uncertainties that could affect anticipated results in the future and, accordingly, these results may differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. For a description of additional risks and uncertainties, please refer to the Company’s filings with the Securities and Exchange Commission.
Clarence E. Smith –President and CEO
Source: ProtoKinetix
ProtoKinetix, Inc.Blair Henderson604-926-6627
***PKTX.. PROTOKINETIX, INCORPORATED.
9176 South Pleasants Highway
St. Marys, WV 26170
***ProtoKinetix Announces New President and Chief ExecutiveOfficer
February 23, 2015
...ProtoKinetix, Incorporated (OTC: PKTX) (www.protokinetix.com) (the "Company" or "ProtoKinetix") announces that a cease trade order issued by the British Columbia Securities Commission was revoked effective as of the date of this news release.
..In connection with the revocation, the Company also announces that it has received and accepted the resignation of Mr. Ross Senior as a Director, President and Chief Executive Officer of the Company effective as of February 19, 2015. Mr. Clarence E. Smith has been appointed as the Company's new President and Chief Executive Officer.
..ProtoKinetix further announces that it has moved its headoffice to 9176 South Pleasants Highway, St. Marys, West Virginia, USA 26170.
About ProtoKinetix
ProtoKinetix is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that dramatically enhance the therapeutic results and reduce the cost of stem cell medicine. Due to the anti-inflammatory effect of AAGP™ molecules, theCompany is currently targeting the direct treatment of diseases that have a major inflammatory component.
ON BEHALF OF THE BOARD OF DIRECTORS
PROTOKINETIX, INCORPORATED
Clarence E. Smith
President and Chief Executive Officer
For further information, please contact:
Clarence E. Smith, President & Chief Executive Officer
Telephone: 304-299-5070
Email: csmith@protokinetix.com
***ProtoKinetix’ Summary of Their Glyco Peptide (AAGP™) Molecule Development
06/17/14
...Over 10-years ago, ProtoKinetix (PKTX) commissioned INSA (French National Institute of Applied Science) to produce a small, stable, synthetic glyco peptide using their gem diflouride platform. The molecule selected was a mimic of a well characterized, glyco protein known as Anti-Freeze Glyco Protein (AFGP). The lead scientist from INSA was Dr. Geraldine Deliencourt.
..During this period of time ProtoKinetix was working of the molecule, a new medical initiative arose from theory to maturity through extensive research conducted on stem cells. This field of research is collectively known as “regenerative medicine”. Regenerative medicine attempts to replace damaged cells or tissues as an effective therapy for a wide range of diseases and conditions such as nerve damage, lung damage, heart damage, etc. ProtoKinetix’ role here is the protection of these cells before, during and after the procedure.
..Under the terms of the original INSA commission, ProtoKinetix paid for the proof of concept in exchange for the worldwide exclusive rights to the family of AFGP molecules. Subsequently, ProtoKinetix has conducted extensive testing on cell preservation and anti-inflammation resulting in substantial data allowing the Company to file patents. To date, the patents have been granted for the United States, Europe and Canada.
..In 2014, PKTX filed for a series of new patents based on results generated by the University of Alberta trials. These are brand new applications protected by worldwide provisional patents.
The Company has completed a series of mechanism of action studies, showing how the molecule achieves its effect of inhibiting inflammation and protecting cells from premature death. This data will enable PKTX to more clearly identify the optimal therapeutic uses for disease.
..Stem cell research has demonstrated major benefits of using AAGP™ during the following stages:
1. Freeze/thaw recovery (cryopreservation)
2. Primary differentiation
3. Migration to progenitor status (precursor cells)
4. Transplantation
5. Engraftment
6. Protection against anti-rejection drugs
***ProtoKinetix Completes Sale of Exclusive Rights for AAGP™ Blood PreservationApplications
March 5, 2014
...ProtoKinetix (PKTX) (www.protokinetix.com) has announced the sale of one of the numerous cell protection applications that prove to significantly increase the shelf life of delicate cells and organs by the addition of AAGP™. The purchaser, Intrepid Innovations Corporation, is a wholly owned subsidiary of Umbra Applied Technologies Group (UATG) and has been funded to address the world-wide demand for blood product storage, and platelet preservation.
Intrepid is completing this transaction with a combination of cash and securities totaling $2,500,000 USD to PKTX. This acquisition will enable Intrepid to complement their blood bag delivery system and further satisfy the growing domestic and international requirement for blood product trauma treatment.
***ProtoKinetix Sells Exclusive Rights to One of the Numerous AAGP™ Applications Numerous AAGP™ April 1st, 2013
...ProtoKinetix (OTCBB: PKTX) (www.protokinetix.com) has entered into the sale of exclusive rights to use it's AAGP™ molecule in all blood and blood platelet preservation applications. These rights have been sold to Intrepid Innovations Corporation for $2,500,000 USD after their extensive review of the AAGP™ molecule's ability to extend blood and blood platelet shelf life.
Intrepid Medical Technologies is a wholly own subsidiary of Intrepid Innovations Corporation that has been specifically funded to address the worldwide need for blood and blood platelet storage and preservation. Intrepid Medical (www.intrepidmedical.net) will be headed up by Mr. Tom Snyder. Tom is a graduate of Princeton University and Harvard Business School. Mr. Snyder brings financial and entrepreneurial experience to Intrepid Medical and has experience in blood diagnostics and therapeutics with Hyland Laboratories and Fenwal divisions of Baxter International.
This Agreement will serve as a blueprint for the commercialization of the numerous AAGP™ applications. The partnering format gives ProtoKinetix the flexibility to structure the sale of application rights to almost any qualified partner. This approach minimizes the cash requirement for product development and the fastest possible entry into the market.
About Intrepid
Intrepid Innovations Corporation is a diversified operation that has acquired, licensed or is developing a wide range of Intellectual Property Rights that offer the opportunity to integrate and commercialize these innovations on a global basis. These proprietary technologies range from wind power generation, oil and natural gas production, wood waste by-products to medical waste disposal and blood preservation.
About ProtoKinetix
ProtoKinetix, Inc. is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP™) that dramatically enhance the therapeutic results and reduce the cost of stem cell medicine. Due to the anti-inflammatory effect of AAGP™ molecules, the Company is currently targeting the direct treatment of diseases that have a major inflammatory component.
***ProtoKinetix Forms Joint Venture Partnership to Launch a Dermatitis Therapeutic Product for the Skin Care Industry
April 27, 2011
...ProtoKinetix (OTCBB:PKTX.ob - News) (www.protokinetix.com), is pleased to announce, that it has entered into a Joint Venture Agreement with Imaginative Research Associates, Inc. to formulate a topical anti-inflammation product for the skin care market. Over the last 23-years Imaginative Research Associates, Inc. has successfully partnered with several large pharmaceutical dermatology and cosmetic companies and has licensed out patents and know-how to launch many leading products in the skin care arena. Naomi Vishnupad, Ph.D., is the President and COO of this Massachusetts based firm and has over 10-years of experience in the pharmaceutical industry in all areas of drug development. She has held positions in both big pharma, such as Wyeth Pharmaceuticals and Bristol-Myers Squibb, and small biotech companies. Naomi holds a Ph.D. and M.S. in immunology and a B.S. in biology.
Upon completion of this formulation, the Joint Venture will be able to offer a topical preparation to specifically address skin conditions caused by inflammation. Conditions such as dermatitis, psoriasis and eczema are often treated with applications of corticosteroids or immune modulators, both of which carry inherent, long term health risks. ProtoKinetix' AAGP™ has consistently demonstrated powerful anti-inflammatory properties without toxic side effects. The formulation and development of this therapeutic product line will offer hope for an effective prescription and over the counter preparations to combat these chronic inflammation causing diseases, while eliminating potential risks from many of the current front line treatments.
ProtoKinetix Receives Excellent Results from the University of British Columbia Eye Inflammation Study
September 21 - 2011
ProtoKinetix (OTCBB: PKTX) (www.protokinetix.com), is pleased to announce that it has received excellent results from the eye inflammation study conducted by UBC (University of British Columbia). The tests conducted by Dr. Gregory-Evans MD, PhD, FRCS, FRCOphth, were designed to determine whether the powerful anti-inflammatory AAGP™ molecule could be successfully delivered to inflamed areas throughout the eye. The result demonstrated that AAGP™ penetrates through the extremely protective barriers of the eye without side effects.
ProtoKinetix has proven the ability of AAGP™ to protect human cells against inflammation causing agents. There are many forms of eye inflammation that are typically treated with an aggressive course of corticosteroids. Due, in part, to the short effective life of topical steroids, current treatments involve the application on an hourly basis. These powerful drugs can lead to numerous sight threatening complications.
Dr. Gregory-Evans, a professor of Ophthalmology and Leadership Chair in Macular Research, concludes that AAGP™ penetrates the eye when topically applied as a twice a day or four times a day regimen. AAGP™ can be detected within the cornea and ciliary body. Drug was also seen to appear in retinal tissue, most convincingly when a four times a day regimen was used.
These results represent a major step in the development of a potent, non-steroidal, anti-inflammatory drug.
Italian Laboratory Expands ProtoKinetix' Market for AAGP™
December 07 - 2011
ProtoKinetix (OTCBB: PKTX) (www.protokinetix.com) is pleased to announce results from Areta International laboratory in Italy. These results show dramatic increases in the production of monoclonal antibodies when AAGP™ is incorporated into the production cycle. Monoclonal antibodies are one of the fastest growing sectors of the pharmaceutical industry. This market is presently over $50-billion USD per year and growing rapidly. As a therapeutic, monoclonal antibodies do not cause the same side-effects of chemotherapy and radiation treatment.
Since the Company continues to focus on the anti-inflammation applications of AAGP™, they intend to partner the monoclonal antibody development to pharmaceutical laboratories. Monoclonal antibodies have proven themselves to be highly effective therapies and diagnostics, in a growing list of diseases. Access to this class of drug is extremely restricted, due to the prohibitive cost. In order for monoclonal antibodies to be universally available, the cost has to be aggressively reduced.
Initial results from these tests demonstrate a 300% to 500% increase in monoclonal antibody production in the presence of AAGP™. This significant increase in yield, will result in major cost reductions for the treatment of cardio vascular disease, auto-immune disorders, leukemia, transplant rejection, cancer as well as numerous diagnostics.
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