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spelling error "by 1 PM"
lots of volume again today 190,000 4/2/25 buy 1 PM
"maybe in our graves we will know what's up lol"
They are not recruiting anymore, i know that for a fact. Idk why they don't update the status, must be a bureaucratic/digital hassle that make them not changing the status. But holy hell, can they give a real update on the advancement of this study lmao this is crazy, maybe in our graves we will know what's up lol
One has to wonder how accurate this report is and if a study is actually ongoing
It seems rather odd that recruiting is still open passed the date of the Estimated Study Completion Date
https://clinicaltrials.gov/study/NCT03073577?tab=results
"Patient recruitment is one of the most critical elements of a clinical trial. Without sufficient participation, studies will lack the power to demonstrate the statistical significance and efficacy of new treatments. Ultimately, poor patient enrollment will delay or prevent new therapies from reaching the market."
clinical trials study was due last week . See if they just change the date again like they did two months ago https://clinicaltrials.gov/study/NCT03073577?tab=results
I didn't lose money with SPPH, silly, as you and your French Canadian mafiosi paymasters behind PKTX well know.
I spotted as a scam from the get-go, and the SEC and AMF both (eventually) agreed with me.
Didn't stop your criminal chum SPPH's CEO Max Arella from being on PKTX' Board of Directors for quite a time after the scandal broke though. Your chum Jean-Francois likes the veneer of respectability that a crooked academic gives his scams.
Here's the start of the receipts:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=56325141
***PKTX.. Well, Well.. Ole Sun is still Kicking.. I guess the back door "Kick back" money is still flowing your way.. All the money you lost with Spencer Pharmaceutical hasn't slowed you down one bit.. you Need to change your businesses from "attacking" to smarter investing.. Enjoy your day ole Wise One..
“ At December 31, 2024, we had a $4,697 shortfall in cash and negative $3,647 in total current assets. As of December 31, 2024, we had a negative working capital equity deficit position of $127,694. Although as of the date of this Annual Report we do not believe we have sufficient capital to meet cash flow projections and carry forward our business objectives in the short-term, the Company will need additional working capital to continue its medical research or to be successful in any future business activities and continue to pay its liabilities. There can be no assurance that in the future we will be able to raise capital from outside sources in sufficient amounts to fund our business.”
see what happens next week. I am wondering if the results of the study are coming soon?
interesting to see volume early in the day 3/27/25. 108000
only if they didn't own any before that. If I bought at .008 and sold at .015, the stock I bought years ago at .02 or whatever gets sold for a loss.
Looks like whoever bought a boat load at 0.008 ..... sold last week at 0.015 for a nice, almost 💯, profit !!!
unfortunately, so much for that outlook
kind of a disappointing week for this stock. There was a ton of volume.
I recall thinking that was misleading, especially the headline. The stem cells restored the vision . The AAGP help the stem cells survive.
I don't recall it curing blindness in mice, but it helped the cells implanted in the eyes thrive instead of disappointing the researchers
Huge potential...already clinically tested and safe on humans...cured blindness in mice...
***PKTX..
Stem Cell Therapy Reverses Diabetes..***
According to a new study published in Science Advances, researchers have developed a novel cell transplantation technique that successfully reversed type 1 diabetes in mice, using human islets vascularized with adaptable endothelial cells for functional subcutaneous engraftment.
Breakthrough in Islet Transplantation
The innovative technique employs human reprogrammed vascular endothelial cells (R-VECs) to functionally vascularize pancreatic islets, addressing a major challenge in islet transplantation therapy1. This approach enables:
In vitro functional vascularization of islets with responsive glucose-stimulated insulin secretion
Successful reversal of hyperglycemia in diabetic mice through subcutaneous transplantation
High levels of human insulin in recipient serum, with hyperglycemia returning upon graft removal
R-VECs, engineered by transiently expressing the vascular-specific transcription factor ETV2, demonstrate remarkable adaptability by self-assembling into perfusable vascular networks and acquiring islet endothelial cell-specific characteristics when cocultured with human islets12. This breakthrough represents a significant step towards improved islet transplantation therapy, potentially offering a path to long-term insulin independence for type 1 diabetes patients34.
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Role of R-VECs in Vascularization
Microenvironmental determinants of endothelial cell ...
Reprogrammed vascular endothelial cells (R-VECs) play a crucial role in enhancing islet transplantation outcomes by providing robust vascularization. Their unique properties and adaptability make them particularly effective for supporting islet survival and function:
R-VECs form extensive vascular networks that arborize and penetrate islets, mimicking native pancreatic vasculature12
When co-cultured with islets, R-VECs acquire islet endothelial cell-specific characteristics, demonstrating remarkable adaptability34
R-VEC-formed blood vessels have larger diameters (13.5 ± 7.5 µm) compared to native human islet capillaries (6.8 ± 2.1 µm), potentially improving blood flow1
Cotransplanted R-VECs contribute substantially more to islet vascularization than host endothelial cells in subcutaneous transplants1
The vascular network formed by R-VECs successfully anastomoses with host circulation, ensuring long-term graft survival31
This advanced vascularization technique addresses a major challenge in islet transplantation, potentially improving graft survival and function while enabling transplantation in more accessible sites like the subcutaneous space.
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Subcutaneous Transplantation Success
Subcutaneous transplantation of vascularized islets marks a significant advancement in type 1 diabetes treatment. This site offers several advantages, including a large surface area, easy accessibility for transplantation and monitoring, and potential graft retrieval if necessary1. Previous attempts at subcutaneous islet transplantation had failed due to insufficient vascularization, but the use of R-VECs overcomes this challenge by forming blood vessels that arborize and vascularize the islets, effectively connecting with the host circulation23.
Transplanted R-VECs form functional blood vessels that support islet survival
Subcutaneous site allows for non-invasive monitoring and potential graft removal
Successful reversal of hyperglycemia in diabetic mice demonstrates the technique's efficacy12
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Implications for Type 1 Diabetes
This innovative approach addresses several key challenges in islet transplantation therapy, including the scarcity of donor organs and islet loss due to disconnection from extracellular matrix and vasculature during isolation1. By enabling effective vascularization, the technique potentially reduces inflammatory and rejection reactions that compromise islet survival1. Importantly, this method may pave the way for transplantation without the need for lifelong immunosuppression, a significant drawback of conventional approaches2. The success of this technique in animal models represents a promising step towards translating this therapy to human patients, offering hope for a more effective and durable treatment for type 1 diabetes34.
This one may have potential....What is the OS?
Yeah but still very interesting to see a successful therapy using islet transplant to cure diabetes 1, which is making headlines.. And it's making headlines while it was conducted on mices, PKTX study is on human beings, much more impactful
they don't mention anything obvious specifically about AAGP or any companies. though. Could be all sorts of other research involved in islets transplantation.
***PKTX.. Dearest Ole Sun.. Have a Good Day and go back to sleep.. :+)
With volume like today’s so far, how could it fail?
it's got to reach .05 first : )
Company gonna get bought out ...... at $0.05 per share.
.0142 with nice bid support!
NEWS COMING!!!!!
your attitude seems to have changed
surprised there isn't more insider buying if something is going on that's positive
see what happens next week.
News coming????
Watch for a jump in PPS
nice volume and a tiny increase in price
no movement in price, but nice volume
HyperPirate75, I see you are new to Investor's hub and to PhotoKinetix's board. Welcome to the IHub board. I look forward to your thoughts regarding PhotoKinetix's Islet transplant test.
Interesting opinion but i think you are wrong, this stock has been manipulated and accumulated for years, if they do end up posting positive data for a study about diabetes 1, the stock will go up. Islet transplant is a very new method to treat diabete 1 and Alberta uni is at the forefront of this new method, if PKTX enables safer and more efficient islet transplant, it will be a big deal
The share price will never move up. If it ever gets to five cents ..... those who bought millions and millions of shares at one cent or less will dump them all. Then the PPS will collapse again. The only true way for everyone to get something out of this stock is for there to be a negotiated total buyout. (only my opinion)
2021 was the last time this stock crossed through both the 50 and 200 day moving averages.
I am not selling. When people stop selling, it might move up
Big volume today....but as you see the PPS doesn't move....
***PKTX..If you call almost a million trades low.. :+O
Wow. Very little volume again today
***PKTX.. Whatever you say.. Ole Wise One.. :+)
shmp has just about set itself on fire. They had a fire years ago and are worth less now than after the ashes were swept up
***PKTX.. Dear "disgusted investor"...I hope your day is going well.. I have a question for you, why do you say "One thing about PKTX" on this MB, But say something totally opposite on another MB..(Natural Shrimp Inc.(SHMP).. About PKTX..???
***(Your Quote).."this stock is worse than my PKTX AAGP stock Protokinetix"..
***disgusted investor.. Don't worry about your comment on that MB(Natural Shrimp Inc.(SHMP)..At least we "Now" know what you are here on PKTX for..
***Have a great day, tell your buddy SPORT19 hello.. :+)
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PROTOKINETIX INC.
CORPORATE OFFICE
412 Mulberry St,
Marietta Ohio 45750, USA
Tel: (304) 299-5070
EMAIL: contact@protokinetix.com
CEO:
Clarence E. Smith
BUSINESS MODEL
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
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Ammendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials Have Been Approved by Health Canada
August 27, 2020ProtoKinetix, 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.
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
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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
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:
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
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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
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.
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:
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***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, 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)
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.
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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.
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.
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.”
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.
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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
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.
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.
“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 (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
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.
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.
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.
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.
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.
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.
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
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
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