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What it's ALL about.. Change. Got a minute, good reading..
Blood Platelets
Blood platelets are a blood product called coagulants. They clot blood and thus prevent people from serious bleeding and often fatal blood loss.
Blood platelets have a shelf life of 4.5 days and then discarded because of bacterial contamination.
If blood platelets are refrigerated they go into coagulation and cannot be used.
Laboratory tests have shown that when AAGP™ is used with blood platelets they can be stored at refrigeration temperatures without coagulation.
The shelf life can be extended to 21 days and more. The amount of blood platelets available for patients can now be increased five-fold without increasing the donor base.
For approximately 40 years before the HBS platelet preservation technology was developed, companies and individuals tried without success to preserve platelets using various methods. Platelets, the tiny congealing component of blood, are extremely sensitive to cold and heat.
At the hospital level, there is an annual total of approximately one billion dollars in lost revenue from outdated and discarded platelets. This loss is comprised of approximately 20% of all processed platelets from North America, Europe and Japan. The limited shelf life for platelets stored at room temperatures creates a variety of problems including less efficient platelet performance and bacterial damage, which can be dangerous to the recipient.
The primary use of blood platelets is for cancer patients undergoing chemotherapy treatment. The process of chemotherapy temporarily destroys the body's ability to produce platelets. Cancer patients frequently have compromised immune systems, so bacterial infections in platelets present a significant risk to this group.
To ensure the safety of blood and blood products, FDA-required testing must be conducted following collection, cutting into the platelets' viable life cycle, but critical to control infected blood. Platelets collected on a Friday must be processed, tested, inventoried and delivered. However, by Monday their functional life is nearly over. Without sufficient time for testing, inventory management and transportation, platelets frequently spoil before there is an opportunity to infuse them.
Using our breakthrough technologies, our HBS goal is to provide effective and inexpensive solutions to these problems and simultaneously could recover up to 90 percent of revenues that would otherwise be lost.
A Proprietary Non-toxic Preservation System
Our innovative preservation method employs no preservatives or cryogenic techniques. It combines the platelets with a non-toxic solution comprised of infusible liquid materials.
Simple to Use, Operate, and Maintain
Simple protocols including industry-specified labeling make it easy for blood centers to adapt our products to their present system.
Economical and Profitable
Amazingly, blood centers and hospitals worldwide lose an estimated one billion dollars in revenue annually due to discarded platelets. In 2002, it is estimated that more than 1,000,000 units of spoiled platelets were discarded in North America, Western Europe, and Japan. As platelets represent the single most profitable blood component sold by blood centers, the ability to extend platelet shelf life and recoup revenue forfeited through spoilage would significantly improve the centers' profitability. Extending the preservation time from five to 10 days may allow blood centers and hospitals to recover up to 90 percent of revenues lost due to outdating.
PLATELETS: THE MIRACLE COMPONENT OF BLOOD
The Human BioSystems' biological preservation program is a technologically advanced preservation and storage system intended to extend the shelf life of platelets, the congealing component of blood. Cancer patients undergoing chemotherapy treatments are the predominant recipients of platelet transfusions. Other persons that often require platelet transfusions are patients undergoing extensive surgery, trauma or burn victims and individuals with platelet deficiencies such as caused by bone marrow disease.
Currently, platelet storage time is limited to a maximum of five days as mandated by the FDA. Due to the fact that they are stored at room temperature creates potential bacterial problems and a loss of platelet functionality. Thousands of units of platelets are discarded at the end of the five-day period, creating shortages and waste that cost extraordinary amounts of money. Platelets older than three days may contain a high bacterial count causing a risk of infection to patients. In Japan the government requires that all platelets be used within three days.
The FDA presently requires blood banks to perform tests to screen for viral diseases, which can take up two days. Currently bacterial testing has not been mandated due to the short period of time remaining for infusion. However, this situation may change because of consumer and government pressure to have blood centers and hospitals test for bacteria. If the FDA rules in favor of this proposed regulation it will undoubtedly cause many problems for the blood industry. The goal of HBS is to change this storage dilemma. With two issued patents and other pending, our unique technologies may double the storage period for platelets, dramatically reduce bacterial growth and maintain better platelet functionality. Upon further development and regulatory approvals, we expect to be a major supplier to the industry with our improved platelet storage technology.
Research: Slichter Lab Puget Sound Blood Services
Platelet Transfusion Research
Background: Platelets are the blood cells involved in blood clotting. Platelets are prepared for transfusion by taking donated whole blood units and spinning them in a centrifuge. By using specific spinning conditions, the smaller, lighter platelets can be separated from the heavier red and white cells. Platelets are then stored in a small amount of residual plasma (the fluid part of the blood). Patients require the pooled platelets harvested from four to six units of donated blood to constitute an adequate transfusion dose to prevent or control bleeding in patients who have low platelet counts.
Alternatively, enough platelets can be harvested from a single donor to give a transfusion dose by a procedure called apheresis. In an apheresis procedure, the donor’s blood is drawn from a blood vessel in one arm; this blood is passed through tubing into a spinning centrifuge bowl. The platelets are separated from the other blood components in the centrifuge. The separated platelets are automatically transferred to a collection bag and the other blood products are returned to the donor through a line placed in a vein in the opposite arm. This process is continued until enough platelets are collected from the donor for a transfusion dose. This apheresis procedure requires about one and a half to two hours of the donor’s time as opposed to collecting a unit of blood, which takes only about 20 minutes of the donor’s time.
Because of the demand for platelets, both methods of preparing platelets are used in order to meet patient’s needs. The majority of platelets (about 60% - 70%) are given to patients with cancer. Either the chemotherapy or the stem cell transplant used to treat their cancer prevents the patient’s own bone marrow from making platelets. Often these patients require days to weeks of platelet transfusion therapy, until their own or the transplanted stem cells start making platelets. The majority of platelet transfusions given to cancer patients are given prophylactically to prevent bleeding.
The next biggest use of platelets (30% - 40%) is given to trauma patients or open-heart surgery patients when platelet counts fall because of massive blood loss. These platelets are transfused therapeutically to help control their active bleeding until their vascular system is repaired.
Opportunities for Improving Platelet Therapy
Our current research is focused in three major areas:
· To determine the appropriate dose of platelets to give cancer patients to prevent bleeding;
· To assess whether we can extend the storage time of platelets;
To develop techniques of preventing patients from recognizing donor platelets as foreign and rejecting them.
Determining the Appropriate Dose of Prophylactic Platelets
The Puget Sound Blood Center is one of 17 trial sites across the U.S. that are part of the recently established Clinical Trials Network in Transfusion Medicine/Hemostasis funded by the National Institutes of Health. A prophylactic platelet dosage study in cancer patients, proposed by Dr. Slichter, has been selected as the first clinical trial to be initiated by the Network. In this study, cancer patients are randomly assigned to receive all their platelet transfusions at a low dose, a medium dose or a high dose. The goals of this trial are to evaluate bleeding risk based on transfused platelet dose and how many total platelets are transfused in each study group. The primary objective is to determine the lowest dose of platelets that prevents bleeding. Although enrollment in the study has started, it will probably be another two years before enrollment is completed and the results of the study have been analyzed.
Extending the Storage Time of Platelets
As platelets can currently only be stored for five days, as opposed to the 42 days possible for red cells, the need to collect platelets drives the donor collection system. Dr. Slichter’s lab is actively pursuing techniques to extend the storage time of platelets. Using a physiologic solution instead of residual plasma to store the platelets, our preliminary data suggests that platelets may be stored for up to 13 days. These studies have been done by storing a normal donor’s own platelets, tagging their platelets with a radioactive substance after storage, and transfusing the donor with their radioactively labeled platelets. By drawing serial blood samples from the donor after transfusion, we can determine the recovery and survival of the donor’s stored platelets by measuring the residual amount of circulating platelet radioactivity.
Future studies will involve transfusing the extended stored platelets into patients with low platelet counts to determine their ability to circulate and prevent or control bleeding.
Preventing Transfused Donor Platelets from Being Rejected
Red blood cell transfusions usually require matching for only two blood group systems between donors and recipients (ABO & Rh) to prevent the rejection of donor red cells. Unfortunately, platelets require matching for the very complex histocompatibility system that must also be matched between organ donors and recipients (such as stem cell or kidney transplants) to prevent graft rejection. Platelets are transfused from random donors until the patient shows signs of rejecting these platelets as evidenced by no increase in the patient's post-tranfusion platelet count. If rejection of random platelets occurs, platelets must be obtained from histocompatible matched donors by apheresis procedures to obtain enough platelets to constitute a transfusion dose. The blood center maintains a registry of approximately 21,500 histocompatible typed donors to have a chance of finding one or more matched donors who will be able to provide compatible platelets for the genetically and racially diverse patient populations who require platelet transfusions. These platelet apheresis registry donors have agreed to be typed for histocompatibility markers and are on call to provide platelets for patients who are rejecting platelets from random donors.
Using an animal model of transfusing platelets from random donors, Dr. Slichter’s lab has determined it is the white cells that contaminate the transfused platelets that signal the transfused recipients immune system that donor platelets are being transfused. These contaminating white cells activate the recipient’s immune system causing the rejection of the platelets from random donors. Unfortunately, the centrifugation procedures used to separate platelets from the other blood cells in a unit of whole blood or during an apheresis procedure does not completely remove all of the white cells. In our animal transfusion model, we have preliminary data to suggest that combining two different procedures may effectively prevent immune recognition of donor platelets. First is to remove a large number of white cells by using a filter designed to allow the platelets to pass through but not the white cells. If the filtered platelets are then gamma irradiated, this inactivates the residual white cells that the filter has not removed. Filtration and gamma irradiation procedures are both used routinely in blood centers. If we can show that combining these procedures is effective in preventing platelet rejection, these processes can easily be transferred to clinical application. However, additional animal studies are required to confirm these potentially very significant observations. Following the animal studies, transfusion studies in patients with low platelet counts will be used to determine the effectiveness of these approaches in patients.
Significance
· Platelet Dose: Once the minimal effective dose of prophylactic platelets that prevents bleeding is determined, this will be incorporated into patient care. We expect that the ongoing clinical trial will show that we can substantially reduce the number of platelets needed by cancer patients. This will not only decrease blood centers requirements to obtain donors for platelets but should, more importantly, substantially reduce patient care costs.
· Extend Platelet Storage Times: Having a longer shelf life for platelets will significantly reduce the current outdate rate for platelets as well as decrease our need for donors. It will also mean that we will be able to maintain a much larger inventory of platelets, thereby having a continuous supply of platelets readily available to meet patient needs.
· Preventing Platelet Rejection: Approximately 20% to 30% of chronically transfused cancer patients reject platelets from random donors. For these patients, it requires a substantial time commitment from platelet apheresis donors to support their platelet needs. For some patients, matched platelets are not available, which increases their bleeding risk. Therefore, preventing a transfused recipient’s immune system from recognizing donor platelets as foreign will be a significant benefit to both patients and platelet donors.
Stem Cell research... Amazing discoveries, that will be very important and beneficial for mankind..(IMHO)Protokinetixs will be a part of this amazing chapter in scientific research and advancement in medicine. Organ transplants without rejection...
Immune system trained to tolerate transplanted organs.
Transplanting part of the immune system along with an organ can help to prevent rejection.
Three independent research teams have successfully performed organ transplantations that do not require the recipient to face a lifetime of immunosuppressant drugs to prevent rejection. Instead, the new techniques prevent rejection by training the immune system to recognize the new organ as its own.
The three studies, published this week in the New England Journal of Medicine, are preliminary and involve only a few patients. But if the techniques can be reproduced in a larger population, they could eliminate one of the most enduring scars of the operation: the need to continue taking sometimes-dangerous immunosuppressant drugs.
Thousands of kidney transplantations are performed every year, and nearly 99% of patients in the United States are still alive a year after the surgery. But even when the organ donor is a close relative, the transplant recipient often needs to take immunosuppressant drugs for the rest of their lives to guard against organ rejection. But although the drugs help to prevent rejection, they also increase the risk of infection and are very pricey.
Previous work in animals has suggested ways to avoid taking these drugs. Mice and monkeys given an organ transplant coupled with an infusion of blood stem cells could sometimes be weaned off the immunosuppressant drugs1,2.
Blood stem cells are made by bone marrow and give rise to white blood cells, including the B cells that produce antibodies, and T cells that are important in distinguishing host from donor. Researchers found that transplanting these cells into the host created a hybrid immune system. The transplanted organ was no longer recognized as foreign; it was partly ‘self’,took over.
The new reports all follow this principle, although not the same procedure.
Michael Stormon of the Children’s Hospital at Westmead in Sydney, Australia and his colleagues report on a liver transplantation in a 9-year-old girl with hepatitis3. Her illness, plus a virus she carried called cytomegalovirus, and the immunosuppressant drugs she was given after the operation, had weakened her own immune system so much that her immune cells were almost completely replaced by stem cells brought in by the donated liver. She even had to be re-vaccinated against the measles and the mumps, as the donor had not been vaccinated against them. The girl was able to discontinue her immunosuppressant regime a year after the procedure, and has not experienced any complications in the four years since.
Samuel Strober of Stanford University in California and his colleagues created a similar situation in a patient who received a kidney from his brother4. The patient was treated with radiation and a drug that destroyed his T cells. He then received a new kidney and an infusion of blood that had been enriched for blood-producing stem cells, both from his brother. Genetic tests revealed the presence of the brother's immune cells still circulating in the host’s blood more than two years after the procedure. The patient stopped taking immunosuppressant drugs with no signs of rejection.
Finally, David Sachs of Massachusetts General Hospital in Boston and his colleagues report on transplantations of kidneys and bone marrow in five patients whose donors were not related to them, making rejection more difficult to avoid5. Of the first three patients to undergo the procedure, one patient’s antibodies rejected the organ in the first attempt; the second attempt, however, was successful. Because of this, the researchers added an extra drug to their protocol to destroy the host's antibody-producing B cells in the following two patients. All four of the patients with successful initial transplants were able to discontinue their immunosuppressants in less than a year after the procedure.
Surprisingly, these patients did not continue to produce donor immune cells. Precisely why these patients did not reject their new kidneys is unclear, says Sachs.
Risk–benefit analysis
Bone-marrow transplantation carries its own risk, but the benefits may outweigh that, says Strober. “The short-term potential risks have to be put up against the long-term risks and the side effects and costs of the drugs,” he says. The researchers are preparing to continue the study in more patients. Strober says that if all goes well, the technique could be generally available in five to ten years.
Dear Folks.. Like the ibox for ProtoKinetix shows..PKTX is focusing on the commercialization of AAGP™. The initial focus will be on markets that require little or no regulatory approval:
1. Skin care and cosmetic applications
2. Government contracts for military operations and the CDC
3. Sun Screening agents for skin protection and cell repair
4. Preservation of Blood products and platelets
5. Cryopreservation and refrigeration of cells and tissues
6. Cell and organ preservation for transplantation
It's(PKTX)opening an office in Washington,D.C.. Where else to be, to get into the American drug market..In the middle of the action.
Old News, but good news... With all the new research and discoveries using stem cells.. All the good that it will do and bring forward(quality of life) for mankind.. (IMHO)Protokinetixs will help make a differents with all this research.. PROTOKINETIX INC. (PKTX: OTCBB)
Vancouver, British Columbia, January 22, 2008
ProtoKinetix’ AAGP™ More Than Doubles Stem Cell Recovery
Research in the field of stem cell therapy has exploded over the last few years.
Stem cells are immature, unprogrammed cells that have the ability to grow into
different kinds of tissue. Recent studies have shown that stem cell therapies offer
real hope for the treatment of a wide range of diseases such as leukemia,
diabetes, spinal cord injury, heart damage, brain damage, blood cell formation
and even hair loss.
As a result of current findings, major initiatives are being conducted by large
pharmaceutical and biotechnology companies, research establishments and
universities around the world, to develop stem cell therapies in regenerative
medicine. Unfortunately the demand for stem cells outstrips the supply. One of
the bottlenecks in this rapidly expanding industry and ultimate commercialization
is the ability to deliver sufficient supply of stem cells to advance these programs.
Currently there are a vast number of stem cells lost in the process of cultivation,
storage, transportation and recovery from cryopreservation.
ProtoKinetix reports that repeated tests have confirmed that the addition of
AAGP™ to the cryopreservation process more than doubles the useable inventory
of these very delicate and valuable cells.
And somemore interesting stem cell news:
Protein protects embryonic stem cells' versatility and self-renewal
http://www.eurekalert.org/pub_releases/2008-03/uotm-ppe032108.php
M. D. Anderson team connects REST to regenerative medicine, pediatric brain cancer
HOUSTON — A protein known as REST blocks the expression of a microRNA that prevents embryonic stem cells from reproducing themselves and causes them to differentiate into specific cell types, scientists at The University of Texas M. D. Anderson Cancer Center report in the journal Nature.
Researchers show RE1-silencing transcription factor (REST) plays a dual role in embryonic stem cells, said senior author Sadhan Majumder, Ph.D., professor in M. D. Anderson’s Department of Cancer Genetics. "It maintains self-renewal, or the cell’s ability to make more and more cells of its own type, and it maintains pluripotency, meaning that the cells have the potential to become any type of cell in the body."
The paper posted online March 23 in advance of publication grew from M. D. Anderson research on the protein’s role in medulloblastoma – an exceptionally aggressive pediatric brain cancer.
Embryonic stem cells are essentially blank slates. They have the unique ability to develop from identical, unspecialized cells and then differentiate into distinct types of cells with special functions. In the laboratory, scientists have been able to induce embryonic stem cells to develop into heart muscle cells or insulin-producing cells of the pancreas. The hope is that embryonic stem cells might one day be used to restore or replace failing cells in the human body and perhaps treat a wide range of diseases.
"Embryonic stem cells have a very high potential in medicine," Majumder said. "The critical thing is to learn the mechanisms that could be used to generate a lot of self-renewing embryonic stem cells and be able to differentiate them into various cell types." REST could play a key role in maintaining a steady supply of these cells and in preserving their differentiation capability.
Suppressing MicroRNA-21
In studies using mouse embryonic stem cells, the researchers found that REST disarms a specific microRNA called microRNA-21 or miR-21. MicroRNAs are tiny pieces of RNA that control gene expression by binding to the gene’s messenger RNA.
The team found that MiR-21 suppresses embryonic stem cell self-renewal and is associated with a corresponding loss of expression of critical self-renewal regulators, such as Oct4, Nanog, Sox2 and c-Myc. REST counters this by suppressing miR-21 to preserve the cells’ self-renewal and pluripotency.
The researchers discovered the roles of REST and miR-21 in a series of experiments using cultured mouse embryonic stem cells in either a self-renewal state or a differentiating state. They found that REST expression was significantly higher in the self-renewal state. Withdrawing REST reduced the stem cells’ ability to reproduce themselves and started differentiation — even when the cells were grown under conditions conducive to self-renewal. Adding REST to differentiating cells maintained their self-renewal.
These experiments also revealed that REST is bound to the gene chromatin of a set of microRNAs with the potential to target self-renewal genes. REST controls transcription of 11 microRNAs.
REST Implicated in Pediatric Brain Cancer
Previous laboratory research suggests that the qualities that make REST beneficial in stem cell production and pluripotency may contribute to the development of medulloblastoma, an aggressive type of children’s brain tumor. Medulloblastomas are believed to develop from undifferentiated neural stem cells in the external granule layer of the cerebellum.
In earlier research, Majumder’s group at M. D. Anderson discovered that about half of these tumors overexpress REST, which is not found in most neural cells. "We found that REST is a critical factor in this group of children’s brain tumors," Majumder said, "and that its major function is to keep a group of specific brain stem cells, or progenitor cells, in a state of stemness."
The researchers hypothesize that by maintaining the neural stem cells’ ‘stemness,’ REST prevents their differentiation into normal and distinct types of cells, leading instead to tumor formation. The M. D. Anderson scientists are now exploring whether microRNAs might also play a role in medulloblastomas.
Understanding REST function has applications in both medulloblastoma and embryonic stem cell biology. "Just as blocking REST function has therapeutic potential in medulloblastoma, blocking REST function to allow for differentiation of embryonic stem cells is a potentially critical step in regenerative medicine," Majumder said.
ll news:
More stem cell news:
Therapeutic cloning creates perfect match
http://www.nature.com/news/2008/080321/full/news.2008.686.html
Animal-specific stem cells treat Parkinson's symptoms in mice.
Researchers have used therapeutic cloning to transform a mouse's tail cells into ones that can treat it for disease. The study helps advance the prospect of creating cell lines perfectly matched to human patients.
In therapeutic cloning — also called somatic-cell nuclear transfer — researchers transplant the nucleus from an adult cell into an egg whose own nucleus has been removed. The eggs are used to grow embryonic stem cells, which are then coaxed to form a desired cell type. In this case, the stem cells were differentiated into nerve cells producing the neurotransmitter dopamine. These cells are damaged in patients with Parkinson’s disease, resulting in tremors and loss of muscle control.
The process is laborious and technically challenging. Previous work had shown that dopamine-producing cells formed from embryonic stem cells could be transplanted into mice with a model of Parkinson’s disease1. The transplants successfully relieved symptoms, but in that case the researchers derived the stem cell line from a different (but genetically related) donor, not from the mouse that was being treated.
Therapeutic first
The new study is the first to take cells from a mouse, transform them through therapeutic cloning into a new cell line, and use this to treat the original donor.
The technique is still a long way from application in humans, but does advance the field toward that ultimate goal, observers say. “It’s the next iterative step in the process of showing that nuclear transfer may be a reasonable way of finding patient-specific stem cell lines,” says Evan Snyder, a stem cell researcher at the Burnham Institute for Medical Research in San Diego, California, who was not involved with the work.
Deriving stem cell lines from embryos remains a very inefficient process. The researchers report in Nature Medicine that they generated 187 different lines from 5,099 eggs — an efficiency of nearly 4%2. After the mice received the animal-specific stem cells, they showed signs of neurological improvement within three weeks.
In contrast, transplanted cells derived from unrelated mice often failed to survive in their new hosts. Mice that received those cells showed signs of inflammation in the brain. “This is clearly not something you want,” says Lorenz Studer, a member of the team at the Memorial Sloan-Kettering Cancer Center in New York.
Next steps
The grafted cells also sometimes yielded an overgrowth of undifferentiated cells, probably because other cell types were inadvertently transplanted into the mice along with the nerve cells. An important next step, says Viviane Tabar, a neurobiologist at Memorial Sloan-Kettering Cancer Center and lead author of the paper, is to better purify dopamine-producing cells before performing the transplant. “This is going to be an issue that needs to be dealt with,” agrees Snyder.
There has been recent speculation that therapeutic cloning may one day be abandoned in favour of a new technique that creates cells similar to embryonic stem cells, called induced pluripotent stem (iPS) cells. In this method, adult cells are genetically reprogrammed to revert to an embryonic-like state by insertion of just a few genes. “Nuclear transfer is a very technically complex and time consuming process,” says Snyder. “The subtext that everybody is reading into this is, now that we have reprogramming, who cares?”
But methods for creating iPS cells are also inefficient, Snyder notes, and the technique is still poorly understood. So Snyder says it is important to continue optimizing therapeutic cloning techniques, because it is not yet clear which method will produce cell lines best suited for clinical application. “We still need to pursue this kind of work,” he says. "All of these methods still need to be compared, head to head."
PKTX Breaking out again - This looks real good now....
I've been accumulating. IMO this will pay off shortly.
PKTX(.44) appears to be breaking out to the upside on good volume here.
Looks like any close above .40 will put it above the 2 month downtrend line on a closing basis.
How is it looking in your TA read here?
Looks like it is now breaking out above the upper psar here.
Should we expect a run up if it does?
Very Nice PKTX Move Underway Folks
News/PR's and major developments from PKTX are imminent now.
PKTX has publicly announced thru its last few PR's ... that PKTX is currently engaged in active negotiations with pharmaceutical companies to commercialize PKTX's AAGPtm molecule. This is an extremely strong public statement to make.
We should be expecting new PR's and major news developments in the days to come.
Is everyone here aware of this.
Is anyone else accumulating here.
When the first commercialization deal is announced ... this stock will really run ... IMO.
How many are following this opportunity here?
Past and Present. I'm accumulating now. At this price range you can't loose. I agree, one deal,and this thing is going through $1.00. IMO sooner than later.
Dear Skyyy... I've started accumulate more again.. Just waiting to see where the dust will settle with Protokinetix..(IMHO) I feel the skincare and cosmetic industry will be PKTX first go at bring in $$$$.. Skincare and Cosmetics
Industry sources estimate that the skincare market in the USA, including both mass and prestige, will reach $7.2 billion by 2010, driven in part by expected double-digit growth of anti-aging products, which is likely to become the second largest category behind hand & body lotions in the industry.
According to the Johnson and Johnson 2003 Annual Report, the global skin care and cosmetics market is already running easily in the tens of billions at some $43 billion dollars per year.
Everyone is talking about anti-aging; and in the skin care business it`s about healthier, younger looking skin.
The two major causes of dry, wrinkled, less elastic or even diseased skin are inflammation and oxidation. The main culprits are the sun (UV rays and free radicals) and other environmental and physiological stresses that also cause inflammation and oxidation.
When AAGP™ is combined with Coenzyme Q10 a powerful anti-oxidant effect is achieved that not only protects but also seems to help the cells repair previously existing damage.
In vitro laboratory tests have shown the AAGP™ molecules can protect in vitro skin cells from damage and death that would otherwise occur from UV rays and free radicals.
To the extent of the laboratory tests conducted, AAGP™ clearly protects in vitro skin cells from cold temperatures, oxidation, UV irradiation and pH variations
PKTX looks like a super strong buy ... right here now.
With all of the negotiations currently going on ... which have been publicly announced by PKTX ... a deal/partnership update and/or major PR can literally be announced at any day now.
IMO ... when good news is announced PKTX is likely to run to $1+ quickly.
Anyone here with thoughts on which developments are most likely to come first?
Is anyone else here accumulating now?
The Charts Are In the iBox
They speak loud and clear.
fringe
Dear Folks... Have we hit bottom as in profit taking??? Or is it time to ACCUMULATE??? Where are our chartist, when you need them most!!
Just to remind everybodies(IMHO) This is where it will start, we have the team ready.. Just waiting for the inking of the deal...Skincare and Cosmetics
Industry sources estimate that the skincare market in the USA, including both mass and prestige, will reach $7.2 billion by 2010, driven in part by expected double-digit growth of anti-aging products, which is likely to become the second largest category behind hand & body lotions in the industry.
According to the Johnson and Johnson 2003 Annual Report, the global skin care and cosmetics market is already running easily in the tens of billions at some $43 billion dollars per year.
Everyone is talking about anti-aging; and in the skin care business it`s about healthier, younger looking skin.
The two major causes of dry, wrinkled, less elastic or even diseased skin are inflammation and oxidation. The main culprits are the sun (UV rays and free radicals) and other environmental and physiological stresses that also cause inflammation and oxidation.
When AAGP™ is combined with Coenzyme Q10 a powerful anti-oxidant effect is achieved that not only protects but also seems to help the cells repair previously existing damage.
In vitro laboratory tests have shown the AAGP™ molecules can protect in vitro skin cells from damage and death that would otherwise occur from UV rays and free radicals.
To the extent of the laboratory tests conducted, AAGP™ clearly protects in vitro skin cells from cold temperatures, oxidation, UV irradiation and pH variations.
What the heck.. Are you saying, it's time for a pizza break!!!!!Where's the PR NEWS!!!!
Washington Business Journal article on PKTX
Link:
http://washington.bizjournals.com/washington/stories/2008/03/17/daily11.html?surround=lfn
Latest News
Washington, D.C. > News > Industries > Health Care - Biotechnology Subscribe to Washington Business Journal
Tuesday, March 18, 2008 - 9:40 AM EDT
ProtoKinetix opens D.C. office Washington Business Journal - by Tucker Echols Staff Reporter
Biotech company ProtoKinetix Inc. will open an office in Washington to accommodate the Canadian company's growth and place it near the region's federal health-related agencies.
In recent weeks, Vancouver-based ProtoKinetix Inc. (OTCBB:PKTX) has expanded its management and business development team to include Dr. Edward Martin of Martin, Blanck and Associates and Donald Weber of Logistics Health Inc. The company also named Randy Anderson vice president of government affairs. Anderson will head up the new office.
ProtoKinetix has developed and patented a family of synthetic anti-aging glycoproteins (AAGP) for medicine and the biotechnology and cosmetic industries.
Ross Senior, chief executive officer of ProtoKinetix, said the move was a significant step forward for the company. He added that, "promising results from a variety of recent tests and preliminary trials using ProtoKinetix' AAGP in cryopreservation of multiple cells lines helped the board reach its decision."
To bad, people can't post something, "ONLY" when Protokintexs goes up!!! It's a great stock, if you look into it!! Was it Warren Buffett, who wrote "Cheeseburger in Paradise"... Take a look closer into PKTX, before jumping ship, Dude!!
Dear Folks... (IMHO) You don't have to go to far to find some very positive news and research from Protokintexs... I'am not pumping or being a cheerleader for this stock but I do believe(IMHO) we are on the edge of something that will change the world as we know it.. Just read the research data, we(PKTX)are forming a team, that will be un-stop-able...We're getting our ducks in a row.......WHAT WE NEED is an inking of a contract with a Big Pharma or a cosmetic company. Period.. Just don't read the PR News but read the Data too.. It's exciting!
ProtoKinetix to Open Washington, D.C. Office
To accommodate growth and to take advantage of current opportunities, ProtoKinetix, Inc. (OTCBB:PKTX) is opening an office in Washington, D.C. In recent weeks, the company has expanded its management and business development team to include Dr. Edward D. Martin, M.D. of Martin, Blanck and Associates, Donald J. Weber of Logistics Health, Inc. and Randy Anderson as Vice President of Government Affairs. The new office will serve as a central hub to access the multiple government and non-government health related agencies. The Washington, D.C. office will enable our business development team to accelerate strategic relationships required to optimize the value of the many applications of AAGP™.
Commenting on this new development, ProtoKinetix’ CEO and President Ross L. Senior said, “This is a significant step forward for the company.” Mr. Senior stated that “the decision to open a Washington, D.C. office is in anticipation of the favorable conclusion to ongoing dialogue with prospective partners and negotiations with commercial entities.” He added that “promising results from a variety of recent tests and preliminary trials using ProtoKinetix’ AAGP™ in cryopreservation of multiple cells lines helped the Board reach its decision.” Randy Anderson will head up this new venture for PKTX and enthusiastically endorses the move as giving a clear direction of where the company is headed. Anderson goes on to say, “We are pleased with recent progress and excited about the short term as well as the extended outlook of the company. I look forward to reporting further developments in the days to come.” About ProtoKinetix ProtoKinetix, Inc. is a biotechnology company that has developed and patented a family of synthetic anti-aging glycoproteins (AAGP™) for medicine and the biotechnology and cosmetic industries. PKTX is currently in dialogue with major corporations and institutions who have contacted the company about the broad range of applications for AAGP™ products.
For more detailed information, please visit our website at: www.protokinetix.com 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.
Mr. Ross L. Senior – President and CEO
PKTX News this morning!
PKTX announces that they are opening a Washington DC office to maximize the various applications of their biotechnology and to target government business and grants.
This is very good news. All of the recent PR announcements are all fitting in to a clear picture and strategy now.
If you read today's PR very closely ... you will see that PKTX is very confident of commercial deals/partnerships coming out of current negotiations with commercial pharma companies.
This is very strong and unique language for a PR. It appears very clear that major developments will be announced in the days to come.
Congrats to all PKTX longs!
Don't be sorry ... That's good stuff.
FlSun
Sorry.... It's the WEEKEND, Enjoy!!!!!
Dear Folks... I know, I know again BUT.. It's the weekend and nobody cares about off-the-wall stuff.. This stuff, what I'am coping to this site, is what, gives us the right to do so.. Just read... Subject: A pin drop
When in England at a fairly large conference, Colin Powell was asked by the Archbishop of Canterbury if our plans for Iraq were just an example of empire building' by George Bush.
He answered by saying, 'Over the years, the United States has sent many of its fine young men and women into great peril to fight for freedom beyond our borders. The only amount of land we have ever asked for in return is enough to bury those that did not return.
You could have heard a pin drop.
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Then there was a conference in France where a number of international engineers were taking part, including French and American. During a break one of the French engineers came back into the room saying 'Have you heard the latest dumb stunt Bush has done? He has sent an aircraft carrier to Indonesia to help the tsunami victims. What does he intended to do, bomb them?' A Boeing engineer stood up and replied quietly: 'Our carriers have three hospitals on board that can treat several hundred people; they are nuclear powered and can supply emergency electric power to shore facilities; they have three cafeterias with the capacity to feed 3,000 people three meals a day, they can produce several thousand gallons of fresh water from sea water each day, and they carry half a dozen helicopters for use in transporting victims and injured to and from their flight deck.. We have eleven such ships; how many does France have?'
You could have heard a pin drop.
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A U.S. Navy Admiral was attending a naval conference that included Admirals from the U.S. , English, Canadian, Australian and French Navies. At a cocktail reception, he found himself standing with a large group of Officers that included personnel from most of those countries. Everyone was chatting away in English as they sipped their drinks but a French admiral suddenly complained that, 'whereas Europeans learn many languages, Americans learn only English.' He then asked, 'Why is it that we always have to speak English in these conferences rather than speaking French?' Without hesitating, the American Admiral replied 'Maybe it's because the Brits, Canadians, Aussies and Americans arranged it so you wou ldn't have to speak German.'
You could have heard a pin drop.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
AND THIS STORY FITS RIGHT IN WITH THE ABOVE...
A group of Americans, retired teachers, recently went to France on a tour. Robert Whiting, an elderly gentleman of 83, arrived in Paris by plane. At French Customs, he took a few minutes to locate his passport in his carry on. "You have been to France before, monsieur?" the customs officer asked sarcastically. Mr. Whiting admitted that he had been to France previously. "Then you should know enough to have your passport ready." The American said, "The last time I was here, I didn't have to show it." "Impossible. Americans always have to show your passports on arrival in France!" The American senior gave the Frenchman a long hard look. Then he quietly explained. "Well, when I came ashore at Omaha Beach on D-Day in '44 to help liberate this country, I couldn't find any damn Frenchmen to show it to."
You could have heard a pin drop.
Organ Transplants
Organs harvested for transplantation must often be transported some distance. The time from donor to recipient is only about 5 hours.
It is estimated that one-third of organs destined for transplantation never make it to the intended recipient. This is a very expensive and time sensitive process that often involves ambulances, planes and helicopters.
Laboratory tests have shown that AAGP™ can extend the viable life of delicate organ cells, such as heart and kidney, with no toxicity or impairment of the organ cell for up to 48 hours.
http://www.humanbiosystems.com/organ_transplant.htm
ORGAN TRANSPLANT
Each year, thousands of lives are lost because there is insufficient time to adequately match the best organ to a recipient and ship it to its destination. Due to the very limited time that an organ remains viable, it often cannot be transported beyond a limited geographic radius. Of the more than 20,000 organs recovered from donors in 2003, approximately 3,000 had to be discarded due to spoilage or damage while others were used for research. Our breakthrough technology could extend organ viability to days and even years versus hours, thus providing a life-or-death difference for patients awaiting organ transplants.
Some Startling Statistics:
A new patient is added to the transplant waiting list every 15 minutes. The waiting list now includes more than 3,100 children under age 17. Of the more than 92,500 people on the list in 2003, only 25,460 were fortunate enough to receive a new organ. In 2003, 5,850 patients died waiting for a transplant.
Our mission is to preserve thousands of organs and offer new hope to thousands of patients waiting for available organs. How long can an organ be preserved with HBS technology? Our goal is to extend shelf life of organs from hours to days and even years while maintaining viability, safety, and quality for successful transplantation.
ORGAN PRESERVATION
Today, the most effective treatment for patients with organ failure is to surgically replace the failed organ with a viable organ from a cadaver or living donor. Organ transplantation can save and improve the quality of life for many patients.
Currently, there are over 173,000 transplant candidates registered on waiting lists in approximately 724 transplant centers throughout North America and Europe. At any given time, approximately 70% of these patients are waiting for kidney transplants. The other patients are waiting for liver, heart, heart-lung, bowel or pancreas transplants. Each year approximately 61,750 new patients receive donated organs.
Many countries that have restricted organ transplantation in the past due to traditional, cultural and religious reasons have recently lifted such restrictions. Japan, for example, legalized organ transplantation in late 1998.
The increasing number of organ transplantations requires more available organs and increases the need to store donor organs. Testing and transportation time to get the best possible match of organ donor to the recipient increase the need for improved organ storage methods compared to what is currently available.
How long can an organ be stored with Human BioSystems' technology prior to transplantation?
Our goal is to extend shelf life of organs from hours to days and even years while maintaining viability, safety, and quality for successful transplantation, reduce hospital stays and allow scheduled versus emergency procedures to be the rule.
The most viable preservation and transportation technology for organs -
We are dedicated in becoming the leading supplier of extended preservation and transportation technology for the organ market. With existing preservation methods, the human heart and lungs are viable for only four to six hours, whereas the liver and the pancreas can be stored marginally longer
The Aging Brain Helped By Injection Of Human Umbilical Cord Blood
Main Category: Stem Cell Research
Also Included In: Neurology / Neuroscience; Seniors / Aging; Biology / Biochemistry
Article Date: 11 Mar 2008 - 3:00 PD
When human umbilical cord blood cells (UCBC) were injected into aged laboratory animals, researchers at the University of South Florida (USF) found improvements in the microenvironment of the hippocampus region of the animals' brains and a subsequent rejuvenation of neural stem/progenitor cells.
Published online at BMC Neuroscience (http://www.biomedcentral.com/1471-2202/9/22), the research presented the possibility of a cell therapy aimed at rejuvenating the aged brain.
"Brain cell neurogenesis decreases dramatically with increasing age, mostly because of a growing impoverishment in the brain's microenvironment," said co-author Alison Willing, PhD, of the USF Center of Excellence for Aging and Brain Repair. "The increase in neurogenesis we saw after injecting UCBCs seemed to be due to a decrease in inflammation."
According to lead author Carmelina Gemma, Ph.D., of the James A. Haley Veterans Administration Medical Center (VA) and USF, the decrease in neurogenesis that accompanies aging is a result of the decrease in proliferation of stem cells, not the loss of cells.
"In the brain, there are two stem cell pools, one of which resides in the hippocampus," explained graduate student and first author Adam Bachstetter. "As in other stem cell pools, the stem cells in the brain lose their capacity to generate new cells. A potent stressor of stem cell proliferation is inflammation."
Prior to this study, the research team led by Paula C. Bickford, Ph.D., of the VA and USF found that reducing neuroinflammation in aged rats by blocking the synthesis of the pro-inflammatory cytokine IL1B rescued some of the age-related decrease in neurogenesis and improved cognitive function.
"We think that UCBCs may have a similar potential to reduce inflammation and to restore some of the lost capacity of stem/progenitor cells to proliferate and differentiate into neurons," said Dr. Bickford.
The study found that the number of proliferative cells increased within 24 hours following the UCBC injections into the aged laboratory rats and that the increased cell proliferation continued for at least 15 days following a single treatment.
"We have shown that injections of UCBCs can reduce neuroinflammation," concluded co-author Paul R. Sanberg, Ph.D. D.Sc. director of the Center of Excellence for Aging and Brain Repair. "Our results raise the possibility that a cell therapy could be an effective approach to improving the microenvironment of the aged brain and restoring some lost capacity."
Cord blood is a "biological" product and--pending FDA licensure of cord blood--the proper context for cord blood banking and for using cord blood in treating patients is under an FDA IND exemption. This is because, from a regulatory viewpoint, cord blood is currently considered an experimental source of hematopoietic (blood-forming) stem cells. Patients who are given cord blood transplants, therefore, are considered "human research subjects" and are entitled to protections under pertinent FDA and U.S. Office for Human Research Protections (OHRP) rules. Under those rules, each Transplant Center, for example, must obtain approval from its own Institutional Review Board (IRB), must use cord blood under research protocols and is responsible for obtaining consent from their patients who will receive cord blood transplants and thereby become research subjects. Because of our IND, the Transplant Center must report to us on the outcome of each transplant and we, in turn, must report to the FDA.
From the regulatory perspective, the donors of cord blood (the mothers who donate their newborn's cord blood) also are "human research subjects" and come under the same FDA and OHRP protections. For this reason, we collect cord blood following protocols, policies and procedures submitted to the FDA and formally accepted by the IRB of the New York Blood Center as well as the IRBs of each of the hospitals that collaborate with us as a collection center.
To date, more than 33,000 mothers have donated their baby's cord blood to the NYBC's National Cord Blood Program. Our donors come from all ethnic backgrounds: 20% are African-American, 21% Hispanic-American, 8% Asian-American and 48% Caucasian. Ethnic diversity has helped patients of all ethnic backgrounds to find suitable matches, providing equal access to all patients. [See: Why is cord blood important for ethnic minorities?].
Despite its current official status as an experimental stem cell source, cord blood is now widely used as an alternative to bone marrow as a source of hematopoietic stem cells. There have been approximately 6,000 cord blood transplants throughout the world thus far. In the United States, one half of all stem cell transplants from unrelated donors in children now use cord blood. In Japan, this is true for adults as well. Our Program has provided cord blood units for transplantation to over 2,000 recipients to date--approximately one third of all cord blood transplants from unrelated donors worldwide. Most have been affected by leukemia, lymphoma, severe aplastic anemia, other lethal diseases of the blood or immune system or certain inherited metabolic diseases [See: Patients & Outcomes for a listing of all diseases treated].
In considering a transplant, the transplant physician is responsible for assessing whether his or her patient needs a hematopoietic stem cell transplant and, if so, deciding on the most appropriate source of those stem cells--cord blood or bone marrow. When a matching cord blood unit from our bank is being considered for a transplant, we work with the transplant physician to help select the most appropriate unit (based on what we have learned from the reports transplant centers send back to us on their patients who have already received cord blood units from our Program). The physician, however, makes the final decision with the patient or, in the case of a minor, with the family.
This Website attempts to provide accurate and timely information about cord blood transplants and public donation, as well as about technical aspects of our Program's operations. Patients and families considering a possible transplant can read about the potential advantages and disadvantages of cord blood transplantation in Cord Blood Q&A and in a Comparison between Bone Marrow & Cord Blood. Encouraging Patient Stories can be found in the Patients & Outcomes section. Website visitors can find out how the NCBP works in Program Overview. More technical information about cord blood collection and processing can be found in NCBP at Work.
Expectant parents can get useful information about donation from Cord Blood Donation. You can keep current with News & Articles. Use the new SiteMap to help navigate the site.
One of the unique features of the NCBP website is our Public Cord Blood Search program which allows anyone the on-line opportunity to obtain an "informal" preliminary count of possible matching CB units in the NCBP inventory at the time of your search. See the "Public NCBP Cord Blood Search" link at the top of this homepage. Detailed instructions will help guide you through the process.
Great D.D. on that article, Igotbigbulls.. My grandfather was a diabetic and lost a leg due to that problem, caused by diabetes... Again, many people around the world are affected..With the research in many areas, Protokinetix's "AAGP" seem to be on the edge of change..In alot of the ways we think of things being done today(IMHO)..
Another good article for PKTX...ProtoKinetix is ahead of Novocell on this....
http://www.msnbc.msn.com/id/23259462/
Igotbigbulls.. Good article. Giving hope to many..
Very interesting article for PKTX....
http://www.msnbc.msn.com/id/15285941/
apparently the link I just provided changes its story everyday...I'll try to find the article...
Interesting article for PKTX...national news on cord blood stem cells that could save child....
http://www.msnbc.msn.com/id/3041426/
PKTX Weekly Chart w/ Trendlines
Needs to hold .30 and get back around .45 ... quickly ...
For this major trend break to look legit- imho
.37
Very nice News from PKTX today.
They are clearly going after government contracts in Washington DC now.
The story continues to build and grow.
ProtoKinetix Names Key Addition to Its Executive Management Team
ProtoKinetix Inc.’s (OTCBB:PKTX) Board of Directors is pleased to be able to announce the appointment of Randy Anderson as its Vice President of Government Affairs. Mr. Anderson has been a long term governmental liaison specialist, based in Washington, D.C. Randy will be working very closely with our Washington, D.C. team of business advisors. In this capacity, Mr. Anderson will be directing the development of AAGP™ applications into the United States military and government health care initiatives.
ProtoKinetix, Inc. views this appointment as an integral step towards successful collaboration with key U.S. government agencies. ProtoKinetix’ AAGP™ has demonstrated the ability to dramatically extend the shelf life of blood products and platelets. The strategic and economic importance of this application has been clearly stated by Don Weber, Chairman of Logistics Health, in the March 5th PKTX News Release.
ProtoKinetix’ recently appointed member of its Business Advisory Board, Don Weber, states that “I have known Randy Anderson for over 20-years. I first met him when he was working for a national program created by the White House Office of Private Sector Initiatives under President Ronald Reagan. In 2001, I hired Randy to manage the Anthrax Response Team for postal facilities in Washington, D.C. and Trenton, New Jersey under a contract with the Centers for Disease Control and Prevention (CDC). He is an effective manager who knows his way around Washington.”
PKTX and ACEL are my best performing plays.
Both charts look great with strong buy ratings from tradingday.com.
The second one broke out in an 8% up move today.
Imagine how they would both do in a good market!
Congrats to all longs!
PKTX held support strongly today.
Looking for the next leg up now.
Word on this one is spreading nicely.
Any good development on the many possible fronts should pop this towards dollarland in the days to come ... imo.
Again... Sorry, but this subject, needs to be entered...(off-the-wall)..
KILLER BISCUITS WANTED FOR ATTEMPTED MURDER
(the actual AP headline)
Linda Burnett, 23, a resident of San Diego, was visiting her in-laws and while there went to a nearby supermarket to pick up some groceries.
Several people noticed her sitting in her car with the windows rolled up and with her eyes closed, with both hands behind the back of her head.
One customer who had been at the store for a while became concerned and walked over to the car. He noticed that Linda's eyes were now open, and she looked very strange. He asked her if she was okay, and Linda replied that she'd been shot in the back of the head, and had been holding her brains in for over an hour.
The man called the paramedics, who broke into the car because the doors were locked and Linda refused to remove her hands from her head.
When they finally got in, they found that Linda had a wad of bread dough on the back of her head.
A Pillsbury biscuit canister had exploded from the heat, making a loud noise that sounded like a gunshot, and the wad of dough hit her in the back of her head.
When she reached back to find out what it was, she felt the dough and thought it was her brains.
She initially passed out, but quickly recovered and tried to hold her brains in for over an hour until someone noticed and came to her aid.
Linda is a blonde and a Democrat, but I'm sure that is irrelevant.
Dear Folks... Alittle profit taking last Friday(maybe alittle more, who knows)..Looking back in time, I thought Protokinetix usually put out PR News, on a Wednesday.. But it could be anytime???? Do we have any bets on a time frame with PR News VS "Golden Cross" cross over!!For the big picture, are we getting a base ready for lift-off ready(possible contract inking)? Only the chartist know??
hi sky, down a tick but it is a five bagger. Detailed Quote for ProtoKinetix Inc. (PKTX)
$ 0.45 -0.07 (-13.46%) Volume: 119.59 k 3:59 PM EST Mar 7, 2008
While Friday's nickel pullback was disappointing, IMO it was related to the overall weak market most of the week and especially on Thursday and Friday as well as the fact that it has had steady gains for a month. I'm still very bullish.
Gm all, I see that we gained another boardmark :) have a great day all -e-
EURO
This stock has been unbelieveable in recent weeks...the buy rating has been between 88% and 100%...still at 96% what does that tell us.....strong buy here....spread the word
Yeah, it's looking good. Keeping my eye on it.
PKTX Still Going Strong With 96% Buy Rating.
Just like the energizer rabbit -- the beat goes on....
Here's the link:
http://quotes.barchart.com/texpert.asp?sym=PKTX&code=BTDY" target="_blank">http://www.tradingday.com/tbs.html?http://quotes.barchart.com/texpert.asp?sym=PKTX&code=BTDY
PKTX - PROTOKINETIX INC (OTCBB)
Date Open High Low Last Change Volume % Change
03/06/08 0.4500 0.5200 0.4500 0.5200 +0.0300 131100 +6.12%
Composite Indicator
Trend Spotter TM Buy
Short Term Indicators
7 Day Average Directional Indicator Buy
10 - 8 Day Moving Average Hilo Channel Buy
20 Day Moving Average vs Price Buy
20 - 50 Day MACD Oscillator Buy
20 Day Bollinger Bands Hold
Short Term Indicators Average: 80% - Buy
20-Day Average Volume - 215870
Medium Term Indicators
40 Day Commodity Channel Index Buy
50 Day Moving Average vs Price Buy
20 - 100 Day MACD Oscillator Buy
50 Day Parabolic Time/Price Buy
Medium Term Indicators Average: 100% - Buy
50-Day Average Volume - 132222
Long Term Indicators
60 Day Commodity Channel Index Buy
100 Day Moving Average vs Price Buy
50 - 100 Day MACD Oscillator Buy
Long Term Indicators Average: 100% - Buy
100-Day Average Volume - 105863
Overall Average: 96% - Buy
Price Support Pivot Point Resistance
0.5200 0.4267 0.4967 0.5667
PKTX Golden Cross!!!
50 DMA is crossing up and over the 200 DMA!!!
Continued sharply higher stock price from here is coming!!!
First commercial deal PR puts PKTX over $1.00+!!!
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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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