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Smaller is better, those darn "Daltons"... NATIVE AFGP >>
AFGP (Anti-Freeze Glycoprotein) is found in nature as a compound produced by some fish, insects, reptiles, bacteria and plants that enable survival in freezing temperatures.
AFGP acts to prevent ice crystals from spiking and rupturing cells, tissues and organs and thereby causing death. It also has a direct effect on cells by some undefined process.
There has been much scientific research done in an attempt to synthetically replicate AFGPs in research institutions because the protective properties of AFGPs could have commercial applications, primarily in food and crop preservation at freezing temperatures.
Scientific research prior to AAGP has focused on building a stable and more efficient compound with a strong bond.
AAGP™ INVENTION >>
AAGPs™ were invented by Dr. Geraldine-Castelot-Deliencourt and developed and protected by patents in partnership with the Institute for Scientific Application (INSA) of France. For her work in this area Dr. Castelot-Deliencourt was honored in 2006 with France’s highest award for scientific accomplishment – the Francinov Award.
AAGP™ is highly stable and not cytotoxic. The result is a molecule that is extremely small (about 580 Daltons) and can move through tissues and reach targeted cells to protect them from inflammatory and oxidative stresses and in some cases repair damage caused by these stresses.
Back in Feb., and March..To have had PKTXs chart turn into a "cup and handle" would have been great..But who expected an "dinner plate" chart. But two positive things are(mho)happening, we are at least horizon and not going down hill on the charts.. Next, we do have a great team on board.. Did anybody say anything about PR News, oh yes.. It would help a bunch to have some(a signing?).
Win, Place, or Cell Can a company harness stem cells to treat?injured horses?
By Margaret Guthrie
He sees us coming, head out of his stall at Santa Anita racetrack in Arcadia, Calif., ears forward to catch the sounds of voices and the crinkling cellophane that heralds his favorite, peppermints. Four days earlier, Greg's Gold won again, pushing his earnings to $951,000 and setting a track record for 7 furlongs on the closing weekend at Hollywood Park.
None of that seemed likely two years ago. In 2005, Greg's Gold ended a race he won with a bowed tendon. "The ligaments were just shredded," says the horse's trainer, David Hofmans, "and that usually means the end of a racehorse's career." The tendon and ligaments will heal with time off, but the resulting scar tissue reduces flexibility, and the horse is slowed down significantly.
"The initial results need to stand the test of time. I am waiting for evidence that the cure rate is sustained over time." -Larry Bramlage
Hofmans and veterinarian Wade Byrd didn't want the horse's career to be over. Byrd had a solution: After administering a local anesthetic, he made an incision under the horse's tail and removed a pad of adipose tissue, which he sent overnight to a company called Vet-Stem, in Poway, Calif. There, technicians washed the adipose tissue in a phosphate-buffered saline solution and added collagenase and hyaluronidase in an attempt to isolate stem cells. Vet-Stem returned the mixture in a refrigerated container in less than 48 hours, and Byrd injected the cells at the site of the shredded ligaments.
Ten months later, Greg's Gold won his first top-tier stakes race since the injury. He's now raced eight times, winning three and placing in all but one of his races. Hofmans says he would recommend the treatment for other horses: "Absolutely, I think it's the only treatment for this kind of injury."
The company has clearly impressed trainers and veterinarians. Since its founding in 2002, Vet-Stem has treated almost 3,000 horses, according to CEO Bob Harman, including racehorses; polo, dressage, and eventing horses; cutting, roping, and barrel-racing horses; and show horses. (For previous coverage, see www.the-scientist.com/article/display/15804.) George Harmening, a Maryland veterinarian, has treated three racehorses and three dressage horses so far. He says he will use the technique as often as he can in horses that have ligament and tendon injuries. Every horse he's treated so far has had a favorable outcome.
The evidence, largely anecdotal, hasn't convinced everyone yet. In some cases, horses have come in for treatment under false names, which is a common problem: No one wants a competitor to know when their horse has a bowed tendon. "We really need an indication of how many horses have been treated and what the actual success rates are," says Larry Bramlage, a veterinarian with Rood & Riddle in Lexington, Ken.
Rood & Riddle uses Vet-Stem's technology when requested, but it hasn't had the successes reported elsewhere. "The recurrence rate is high and the treated tendon is still weak," says Bramlage, who explains that when a tendon forms in a young horse (or human), it's flexible, but over time loses that flexibility and does not regain it. "The initial results need to stand the test of time. I am waiting for evidence that the cure rate is sustained over time."
The original idea for using stem cells was that they would differentiate into tendon and ligament cells. That's proven wrong, says Vet-Stem advisory board member Art Caplan, who studies stem cell therapeutics at Case Western Reserve University. The stem cells seem to calm the inflammatory reaction and then organize for the self-repair of the damaged tissue. "We had no idea of the trophic effect the stem cells would have," says Harman.
Caplan acknowledges that it's not clear why the technique works: "Clinicians do things because they know or suspect they work; it may take us [researchers] 20 years to explain why."
Caplan acknowledges that it's not clear why the technique works: "Clinicians do things because they know or suspect they work; it may take us [researchers] 20 years to explain why."
The lack of clarity and transparency frustrates Lisa Fortier, who studies stem cell applications in cartilage regeneration in the horse at Cornell Veterinary School. "The way Vet-Stem works makes it very difficult to gather data. Academics are data driven but don't have as extensive a client base as a company like Vet-Stem does, but we keep detailed records." Fortier says she worries that if, over time, the Vet-Stem method does not hold up, people will discard treatments using stem cells as something that doesn't work.
Vet-Stem has also expanded its treatment to dogs. In a recent issue of Veterinary Therapeutics (8:272-84, 2007), the researchers report on a randomized, double-blind study of dogs with chronic osteoarthritis of the coxofemoral joints. They conclude: "This multicenter study shows that intra-articular administration of adipose-derived stem and regenerative cell therapy decreases patient discomfort and increases patient functional ability." Owners of three of the dogs participating in the study were considering euthanasia before the dogs were treated, and those three dogs have improved.
The company is in the process of setting up a pilot study with five investigators (all DVMs in internal medicine), for dogs with chronic inflammatory liver disease. In the meantime, Vet-Stem has an agreement with the Central Veterinary Research Laboratory in Dubai, UAE, to offer the treatment to horses in the United Arab Emirates, Kuwait, Saudi Arabia, and Qatar - countries that are hardly strangers to high-end horses. Vet-Stem is also offering a small pilot program to horse breeders: storage of umbilical-cord perinatal cells for future use in case of injury or disease. Five doses of these cells will be cryogenically stored for each foal's lifetime, for $3,000.
Back at the track, Greg's Gold, like the Energizer bunny, is raring to go, according to Hofmans. He ran in the San Carlos Handicap, a race for 4 year olds and up at 7 furlongs at Santa Anita on February 16. He placed second in that race, nipped at the wire by Surf Cat. He raced again in the San Portrero Handicap on April 5, winning this time, defeating two other Grade I winners, and becoming racing's newest millionaire with earnings of $1,067,923. He will race twice more before the Breeders Cup Sprint in October. He is also starring in Vet-Stem's latest advertising.
PKTX..Yes, I would agree.. PR News about an contract signing, would be nice about now...
PKTC Breaks Long pSAR
Here we go.
Sorry Folks.. I lied about posting, I'am back!!
Brain stem cells can be awakened, say Schepens scientists
Study findings promise to help in treatment of brain diseases
http://www.eurekalert.org/pub_releases/2008-06/seri-b060608.php#
BOSTON, June 06, 2008 /PRNewswire/ -- Scientists at Schepens Eye Research Institute have identified specific molecules in the brain that are responsible for awakening and putting to sleep brain stem cells, which, when activated, can transform into neurons (nerve cells) and repair damaged brain tissue. Their findings are published online this week in the Proceedings of the National Academy of Science (PNAS).
An earlier paper (published in the May issue of Stem Cells) by the same scientists laid the foundation for the PNAS study findings by demonstrating that neural stem cells exist in every part of the brain, but are mostly kept silent by chemical signals from support cells known as astrocytes.
"The findings from both papers should have a far-reaching impact," says principal investigator, Dr. Dong Feng Chen, who is an associate scientist at Schepens Eye Research Institute and an assistant professor of ophthalmology at . Chen believes that tapping the brain's dormant, but intrinsic, ability to regenerate itself is the best hope for people suffering from brain-ravaging diseases such as Parkinson's or Alzheimer's disease or traumatic brain or spinal cord injuries.
Until these studies, which were conducted in the adult brains of mice, scientists assumed that only two parts of the brain contained neural stem cells and could turn them on to regenerate brain tissue -- the subgranular zone (SGZ) of the hippocampus and the subventricular zone (SVZ). The hippocampus is responsible for learning and memory, while the SVZ is a brain structure situated throughout the walls of lateral ventricles (part of the ventricular system in the brain) and are responsible for generating neurons responsible for smell. So scientists believed that when neurons died in other areas of the brain, they were lost forever along with their functions.
In the first study, Chen's team learned that stem cells existed everywhere in the brain by testing tissue from different parts of adult mice brains in cultures containing support cells (known as astrocytes) from the hippocampus, where stem cells do regenerate. In the cultures the stem cells from other brain regions came to life and turned into neurons.
When they compared the chemical makeup of the areas known to generate new neurons in the hippocampus with other parts of the brain, the team discovered that astrocytes in the hippocampus were sending one signal to the stem cells and that those from the rest of the brain were sending a different signal to stem cells.
In the second (PNAS) study, the team went on to discover the exact nature of those different chemical signals. They learned that in the areas where stem cells were sleeping, astrocytes were producing high levels of two related molecules -- ephrin-A2 and ephrin-A3. They also found that removing these molecules (with a genetic tool) activated the sleeping stem cells.
The team also found that astrocytes in the hippocampus produce not only much lower levels of ephrin-A2 and ephrin-A3, but also release a protein named sonic hedgehoc that, when added in culture or injected into the brain, stimulates neural stem cells to divide and become new neurons.
"These findings identify a key pathway that controls neural stem cell growth in the adult brain and suggest that it may be possible to reactivate the dormant regenerative potential by adding sonic hedgehoc, or blocking ephrin-A2 or ephrin-A3," says Dr. Jianwei Jiao, the first author of the two papers.
The next step for the team will be to stimulate the sleeping stem cells in animals who are models of neurodegenerative disorders, such as Parkinson's disease, to see if the brains can repair themselves and restore their damaged functions.
Schepens Eye Research Institute is an affiliate of and the largest independent eye research institute in the country
I agree look at the last two people PKTX has brought on board. An Army General and a Navy Admiral. These folks didn't get to be that rank because they are dummies.
Talk IS CHEAP.. And I'am not talking about me speaking trash. We're here and ready for the next level that PKTX is going to take us to..I been looking for answers, digging deep, looking at, I feel all avenue of information on the internet...I know,(IMHO) we have a great produce and I feel, once to market, we will change the world for best.. The individuals, that have come on board(PKTX) in the last few months...(Everybody needs to see this,"On the net")NOT PR News Crap, dig deep on the internet...Their bio's and what they are capable of, again(IMHO)... They are going to put us(PKTX) on the moon..Sorry, I'am finished with posting for awhile.. Day-traders and flippers are here.. I will accumulate on good dips... GO PKTX!!! I salute them all especially Don Weber, "He's the MAN"!!
Dear Folks...I was told that I'am living in the past.. Well, if we're waiting for the future(Protokinetixs PR NEWS, about an Pharma signing an contract), let's have some action packed reruns.. You people, need to watch Matt Damon's movies, "The Bourne Files", (3 films)...After watching them, you will be "ready" for the future with Protokinetixs....What ever comes, BABY!!!
Post #332... Might be boring to some and very interesting to others. Like the gentleman said in the article, the cosmetic industry is a science and has been around for thousands of years..The last paragraph in the article pretty much sums it up..And(IMHO)Protokinetixs is the bandwagon. Hope everybody is having a great weekend!
"That Cosmetic Market"...The multi-billion-dollar global cosmetics and skin-care-product industry sometimes is beset by a me-too mindset in which research and development focuses on matching the competition rather than applying sound science to improve products, a scientist told the 234th national meeting of the American Chemical Society.
As a result, it could be missing a golden opportunity to provide consumers with more effective products, according to Stig E. Friberg, Ph.D. a chemist who studies cosmetic ingredients.
As an example, Friberg points out that previously unknown changes occur in the structures of colloids used in skin care lotions. As a result, the lotion sitting in the bottle, he said, is actually different from the same lotion applied to the skin.
Friberg has spent years in fundamental studies of the backbone of any lotion -- a mixture or "emulsion" of oil and water. Along with a third ingredient, a surfactant that keeps the liquids from separating, emulsions are the basis of almost every skin lotion. Although the system may sound simplistic, Friberg said it's not as straightforward as scientists once believed.
Friberg's work has revealed that after application, evaporation causes a lotion's internal structure to change, a fact that has not captured the attention of the skin-care industry. Initially in a liquid phase, the structure transforms while on the skin to a more orderly state, such as a liquid crystalline or solid amorphous phase, that allows for a higher tendency for molecules to enter the skin, he said. Previously, scientists have assumed the structure of an emulsion remains intact as lotions evaporate.
But this isn't the case. "In fact, the appearance of liquid crystalline structures in the emulsion acts as if you have a much higher concentration of the active substance on the skin," said Friberg, who is with the University of Virginia. "Knowledge of the structure change will make the formulation of skin lotions more systematic."
A main goal of the system is to find the best active ingredients for a given emulsion. In the land of lotion, these ingredients do the dirty work by penetrating the skin to protect or improve it. Well known active ingredients are salicylic acid used for complexion and camphor as an analgesic. Lotions on the market today, while effective, are based on limited understanding of how the active ingredients smooth and moisturize the skin. Research therefore has been based primarily on efforts to improve traditional, successful combinations of surfactants, oils and active substances.
In a sense, studying new structures would remove some guess work in manufacturing effective lotions because it would remove an unknown from the equation: companies could work from the template of the new structure rather than one that is nonexistent or, at best, flawed.
"I think it would be possible to save some lab work by knowing what is going on, and it could open a new marketing opportunity," Friberg said.
As for cosmetics, tradition has a head start on science, Friberg said. For instance, the latest interest in skin care -- hydroxy acids, the active ingredients in anti-wrinkle creams -- have been used for thousands of years and date back to Cleopatra, whose bath contained lactic acid (a hydroxy acid) which the classic beauty obtained from sour donkey milk.
"Cosmetics have a very long period of use," he said. "The companies involved have a tremendous knowledge of what works and doesn't work just from experience. Once they show somewhere that something works, then everyone jumps on the bandwagon."
Everybody.. Have a great "Memorial Day" weekend..Remember why we can celebrate this event.. Take care! GO PKTX!!
With CCI and William% in the high range and "NO" PR News on the horizon, becareful...Yes, PP shares are going up..But, (IMHO)Just in case, have a escape plan or a parachute!! No good day trader, will leave $$$$ on the table... Especially on a long weekend coming up..Buy on the dip..
Dear Folks.. I believe in this Company(PKTX)...Day traders will control this stock swing(IMHO) until big business or $$$$$ gets back from the beach or their vacations at the end of the summer.. Buy on the dip to accumulation........YEA, BABY!
Dear Folks.. Get BACK to you later, When the Company(PKTX)has informations to give!?!?!?!?
Dear Folks.. With the New "Koenig" PR News...Is it "Another" mouth to FEED in Protokinetix business or is it another alignment, as in "MICROSOFT" the next generation????
NEW Protokinetix PR NEWS..
PROTOKINETIX INC. (PKTX: OTCBB)
May 14, 2008
Former Navy Surgeon General, Admiral Harold M. Koenig, M.D. Joins ProtoKinetix
Protokinetix Inc. (PKTX) Board of Directors, takes pride in the appointment of the former Surgeon General of the United States Navy to its Scientific Advisory Board. Dr. Koenig served in the Office of the Secretary of Defense for Health under Presidents Bush and Clinton. The addition of Dr. Koenig to General Parker’s Science Advisory team gives a dramatic level of credibility to the Company’s interaction with the medical and health care community.
Science Advisory Chairman, General John Parker, M.D., commented, “Dr. Koenig is a significant and important addition to ProtoKinetix’ scientific team. He brings a wealth of scientific and political experience that adds depth and dimension to the strategic interests of the company.” ProtoKinetix’ CEO, Ross Senior, states, “Having an advisor the quality of Harold Koenig is invaluable to our current priority to fully integrate science and business affairs.”
“I am privileged to join John Parker and the other world-class scientists of ProtoKinetix. I believe in the far-reaching potential of their Anti-Aging Glyco Peptides and the revolutionary discovery of Geraldine Castelot-Deliencourt’s synthesized molecule. I believe that we may only be scratching the surface of the long-term contributions AAGP can make to medical science,” Koenig said.
Chairman of PKTX’s Business Advisory Board, Admiral Edward D. Martin, M.D., describes the appointment as “a perfect fit with our objectives to involve AAGP™ in military health care delivery systems and government partnerships.”
"Are Day Traders" coming out of the woodwork or WHAT???? All I can say is thank you, thank you!! "Day Traders" for helping me ACCUMULATE "PKTX" shares at a low PPS, I love it(For the big picture,down the road)!!!!!!
not sure of the reason but if the volume continues, watch out
GREAT VOLUME!!! 217.4K... With no PR News..(Is something cooking, folks)???? Anybody with News, alittle news??
Dear Mothers...I want to wish you a "Happy Mothers Day" and everybody who is a mother too... Happy Mothers Day to ALL...
The reason I'am posting this article on Islet Cells, is that Protokinetixs is doing research on this subject.. Diabetes, is a killer...
Transplanted Pig Cell Islets: A Solution For Diabetes Sufferers?
At present, there are over eleven million diabetes sufferers in the United States; the Center for Disease Control estimates that another six million cases go undiagnosed. A recent series of New York Times articles suggested that diabetes and diabetes-related illnesses account for the nation's number one cause of emergency room visits.
In Type 1 diabetes the immune system attacks and destroys insulin-producing "islet" cells located in the pancreas. Since islet cells cannot repair or reproduce themselves, researchers have been actively pursuing cell transplantation for diabetes.
"Aside from the overwhelming stress and limitations associated with a daily regimen of insulin injections and blood glucose monitoring, Type 1 and 2 diabetes can lead to heart disease, kidney failure, blindness, limb amputations, and other health problems," says Michael J. Andrews, CEO of San Diego, CA-based MicroIslet, Inc. "We're looking to change that."
MicroIslet is engaged in the research, development, and commercialization of patented technologies in the field of transplantation therapy for patients with insulin-dependent diabetes. While the availability of human islet cells is limited by the supply of human donor tissue, xenotransplantation, Microislet's process of transplanting organs from one species to another, could provide an essentially unlimited supply of islet cells for transplantation.
"Pigs, whose insulin differs from the human version by just a single amino acid, are a well-established source for human therapeutics," says Andrews. "Historically, most of the insulin used to treat humans was derived from pigs."
To protect transplanted cells from rejection by the patient's immune system, MicroIslet has developed a unique method of microencapsulation. The process, which involves the surrounding of islet cells with a highly biocompatible biopolymer derived from seaweed, forms an outer covering around the islets, reducing the host's resistance to the transplanted material.
MicroIslet believes its porcine xenotransplantation and proprietary technology may overcome many of the obstacles that have plagued islet cell transplantation. Andrews believes that a minimally invasive procedure consisting of the implantation of microencapsulated porcine islets into the abdominal cavity may provide physiologic and self-regulating blood glucose control. Says Andrews: "This could ultimately enable diabetics to become free of insulin injections and the toxic immunosuppressive drug regimens that traditionally accompany transplants."
Dear Folks... In a nut shell..Read the bottom of the page(message #319).. Marked NOTE: funding requirements..Planning for future advents???
Budget Protokinetix Inc.,
March 1, 2007 to February 28, 2008 Research budget: 1. Funding of Chemistry work in Rouen $255,000.00 2. Scale up manufacture of 550 grams AAGP™ (estimate) $575,000.00 3. Cardiac reperfusion ischemia testing $ 20,000.00 4. Endothelial inflammatory inhibition study $ 30,000.00 5. Solid organ transplant research $ 17,000.00 6. Islet cell transplantation studies (estimate) $250,000.00 7. Ongoing research by ITTEC ($15,000.00/month) $180,000.00 8. Blood and blood product preservation (Strasburg, Fr.) funded 9. Protection against UVA and UVB (U of Bordeaux, Fr.) funded 10. Cardiac research work at Baker Heart Institute funded Total budget for research in next year: $1,327,000.00 Administration and promotion 1. Office rent $ 600.00/month 2. Secretarial salary $2,500.00/month 3. Telephone, Fax, internet $1,500.00/month 4. Courier fees $ 500.00/month 5. Travel& accommodations $5,500.00/month 6. Transfer agent $ 375.00/month 7. Office Supplies $ 300.00/month 8. Bank Charges $ 250.00/month 9. Miscellaneous $ 550.00/month 10. Book Keeper $ 580.00/month 11. Auditor $4,500.00/month 12. Legal $5,000.00/month 13. Investor Relations $7,000.00/month Total monthly expenses $29,155.00 Annual administration budget $349,860.00 Budget for 12 months $ 1,676, 860.00 Business Plan: Primary expenses will be in the research and development area. As this is where the greatest expenses are incurred, it is the area which must be watched most closely. The research will be done, but should there be evidence that a given research project is failing, then funds will be quickly withdrawn from it. Yet, just as the funds will be quickly withdrawn is there is evidence that a projected use of AAGP is not being confirmed, if the molecule is working well in a given area, then additional funds may be required to continue the development of the science in that area. Research costs will be divided according to the following: 1. Ongoing projects a. Chemistry research in Rouen to support the development of the family of AAGP™ molecules. This includes the funding to cover the expenses of equipment, material and salaries for the research lab in Rouen, France. b. Funding of research work by ITTEC. This is the small research firm that has been hired to conduct ongoing testing of the AAGP™ molecules to determine its effect in different biologic applications as well; they are attempting to determine the mechanism of action of the molecule. They also test each of the new batches of the molecule to confirm biologic activity before we proceed to additional testing. In addition, they conduct test on newly synthesized molecules to determine if they have is biologic activity. c. Scale up of the molecule. We have the quote from ALMAC to scale up the production of the molecule. We could choose to have Dr. Deliencourt do the production, but this cannot be classified as “scale up”. Scale up production of AAGP™ is important for the following reasons: i. We must confirm that scale up production is possible. Dr. Caille of Pitsburg Paint and Glass (PPG), an international chemical company, as well as both Dr. Quirion and Dr. Deliencourt are all confident that there will be no difficulty in doing this. While it is reassuring that they feel confident in their ability to scale up the production, we must confirm this by actually doing it. ii. Research on AAGP™ in medical applications requires a consistency in the molecule that they work with. This will only be achieved through the production of a large batch by a scale up process. iii. We are facing an increasing demand from a variety of different industries for AAGP™ so they can work with it to determine if it will be of benefit to them. iv. We have requests from a variety of Universities and Research Facilities that want to trial and then purchase AAGP™ to preserve the valuable cells they are working on. e.g.: stem cell preservation, preservation of hepatocytes (used in toxicology testing) etc. v. There is at this time interest from 4 cosmetic companies, two of which have been conducting research on AAGP™ to assess its anti-aging properties. It is necessary to confirm to them that we are able to manufacture the molecule in bulk. vi. Finally, Protokinetix has met with a Biotechnical Research Analyst from New York. She has done her assessment of the company and has stated that quite impressed with the data that she had reviewed. Her only reservation is the scale up production of the molecule. She noted that the scientists have claimed that scale up manufacturing of the molecule can be readily done, but she wanted to see this task completed. Once this has been successfully done, she has stated that she will publish her research report. vii. We are still awaiting the quote from BASF. 2. Proposed research work
a. Cardiac reperfusion ischemia testing is a very important research project that will be conducted at the University of Calgary in Alberta. This project will assess the ability of AAGP™ to protect heart muscle from the ischemic conditions that develop during a myocardial infarction (heart attack) or during prolonged cardiac bypass surgery.
b. The endothelial inflammatory inhibition study is being designed to determine if the AAGP™ molecule stops or inhibits the inflammatory response. (ITTEC Inc. in Montreal was able to show that AAGP™ did have significant anti-inflammatory properties.) If Dr. Tibbles of the University of Calgary is able to confirm this effect, she will conduct research to determine the mechanism of action.
c. The research that will eventually lead to the transplantation of solid organs will start once initial results from a. and b. are confirmed. The successful preservation of solid organs for transplantation would have very significant implications for medicine and for Protokinetix, Inc. ITTEC was able to preserve rat heart tissue for 21 hours at 3 degrees Celsius. This is a major improvement over the 6 to 8 hours that transplant organizations are presently able to achieve.
3. Developmental Research
a. Islet cell transplant research is ongoing at the University of Alberta. We had conducted an initial research project with 12 mice which were transplanted with150 islet cells, some of which were preserved using AAGP™. Initial results on this small sample were very significant with the mice that had received AAGP™ treated islet cells controlling their blood sugars significantly better than did the control mice. The study is now being repeated on a large scale. If the results are confirmed, the University of Alberta will announce the results and then proceed with additional testing to confirm the protective effect on human islet cells and to take steps to achieve regulatory approval to use AAGP™ for the preservation of human islet cells for transplantation into diabetic patients. The funds for this research would not be required until after we had good results from the mouse experiments (and presumably a significant rise in the share price after the announcement.)
Funds required by Protokinetix Inc.:
1. Immediate requirements:
a. Six months administrative funds: $174,730.00
b. Funding of Chemistry work in Rouen $200,000.00
c. Scale up manufacture of AAGP™ (estimate) $575,000.00
d. Cardiac reperfusion ischemia testing $ 20,000.00
e. Endothelial inflammatory inhibition study $ 30,000.00
f. Solid organ transplant research $ 17,000.00
g. Research by ITTEC ($15,000.00/month) $ 90,000.00
Immediate funding requirements $1,106,730.00
Benchmarks that are to be met include the following:
1. Scale up of the manufacturing process to produce AAGP™.
2. Positive results from the University of Alberta on islet cell preservation
Funding Requirements once benchmarks are met:
Once Protokinetix has completed the scale up and has had good results from research on the preservation of islet cells, then additional funding will be required to cover expenses associated with the research in a variety of medically related areas:
Funding requirement
Funding once the scale up is completed, and
positive results from the University of Alberta $569,665.00
Total funding for the year $ 1,676, 860.00
Note: funding requirements will change once Protokinetix Inc. has signed a contract with a cosmetic firm and also once we begin to sell AAGP™ to companies that want to preserve their valuable cells.
OK, OK..(IMHO)I know something is cooking on the back burner, but when.. And yes, I GOT SHARES and Accumulating MUCHO more!! Talk to you later..
Stem Cells News... YES, This research is world-wide and only getting bigger as a snowball, goes down hill...READ..
$271 Million for Research on Stem Cells in California [NYT]
By ANDREW POLLACK
Published: May 8, 2008
LOS ANGELES — California has awarded $271 million in grants to build 12 stem cell research centers in the state, even as one of the political rationales for the building program might soon disappear.
The awards, announced here Wednesday, represent the largest chunk of money awarded at one time by California’s taxpayer-backed stem cell program, which is slated to spend about $3 billion over about a decade.
The universities and research institutes that are receiving the money have said they would spend an additional $560 million on the laboratory construction, money they are trying to raise from donations. The resulting total of $831 million would add nearly 800,000 square feet of research space to house 2,200 scientists.
One reason the buildings are needed is that the Bush administration now prohibits federal financing of research using any human embryonic stem cells derived after August 2001, because creating such cells entails the destruction of human embryos. That has meant that work involving newer stem cell lines cannot share even a microscope with a project that is federally financed.
At the University of California, San Francisco, for instance, stem cell scientists had to work in rented space off-campus for many years. In December 2002, a huge storm caused power failures in the Bay Area, destroying cell lines that were being grown in incubators. Had the work been conducted on campus, backup generators would have kept the incubators operating.
“Several years of work literally went down the drain,” said Dr. Arnold Kriegstein, director of the university’s stem cell program. The university will now receive $35 million to build a $95 million research center.
But the restrictions might be lifted by a new president as early as next year. All three main presidential candidates have expressed support for expanded financing of human embryonic stem cell research.
“Now that the money is flowing, those federal restrictions are going to be removed,” said Jesse Reynolds, a policy analyst at the Center for Genetics and Society in Oakland, which supports stem cell research but has at times criticized the California project.
Robert N. Klein, the chairman of the board of the California program, the California Institute for Regenerative Medicine, argued Wednesday that the state could not take for granted that federal restrictions would be lifted. Mr. Klein said Senator John McCain of Arizona, the presumptive Republican nominee, had expressed opposition to some types of stem cell research.
Moreover, Mr. Klein and university representatives say that even if the restrictions are lifted, new laboratory space will be needed to expand research and to recruit scientists, who are already flocking to California because of the research financing.
Some officials also said the construction would provide an economic stimulus at a time of a weak economy and a huge state budget deficit. The stem cell program, approved by voters in 2004, is financed by bonds and is largely immune to state budget-cutting pressures.
Alan Trounson, the president of the California Institute for Regenerative Medicine, said the new buildings would allow scientists to work together, accelerating the development of medical treatments.
Proposition 71, the 2004 ballot initiative that authorized the program, limits spending on buildings to 10 percent of the total $3 billion.
AND..YES,(IMHO)Protokinetixs hopefully will be there!
Alittle more on Dr. John S. Parker...John S. Parker, MD
, FACS, FCCP, Major General, USA (ret)
Chief Medical Officer, Health Solutions, SAIC
Dr. John S. Parker has been with the Enterprise and Health Solutions Sector of SAIC since 2002 and leads the company’s efforts supporting the national homeland defense initiatives in the areas of chemical and biological defense, public health and biosurveillance. Dr. Parker is a member of the Homeland Security Coordinating Committee.
Dr. Parker joined SAIC after 37 years of service with the United States Army. Most recently, as Commanding General, U.S. Army Medical Research and Materiel Command and Fort Detrick, Dr. Parker was responsible for the Army’s medical research, product development, technology assessment and rapid prototyping, medical logistics management and health facility planning, and medical information management and technology. Dr. Parker served as the Special Assistant Secretary of Defense (HA) for Medical, Chemical and Biological Defense; Deputy for Medical Systems, Office of the Assistant Secretary for Acquisition Logistics and Technology; Head of Contracting Activity; the Army’s Medical Materiel Developer; and Principal Proponent for Medical Advanced Technology in the Army.
Dr. Parker’s prior key assignments included tenure as Assistant Chief, Thoracic and Cardiovascular Surgery, Walter Reed Army Medical Center; Chief, Thoracic Surgery, Landstuhl Army Regional Medical Center; Division Surgeon, 8th Infantry Division (MECH); Surgical Consultant, 7th MEDCOM and EUCOM; Surgical Consultant to The Surgeon General; Commander, United States Army MEDDAC, Fort Carson; Chief, Medical Corps Branch, PERSCOM; Commanding General, Fitzsimons Army Medical Center and Installation; Commanding General, Central Health Services Support Area and DOD Lead Agent for TRICARE Region 8; Assistant Surgeon General for Force Projection, Deputy Chief of Staff for Operations, Health Policy and Services, USAMEDCOM and Chief of the U.S. Army Medical Corps.
Dr. Parker received a doctorate in Medicine from Georgetown University of Medicine in 1974 and a bachelor’s degree in Biology, Philosophy and Journalism from Washington and Jefferson College in 1963. He is a diplomat of the American Board of Surgery and the American Board of Thoracic Surgery, a fellow of the American College of Surgeons and the American College of Chest Physicians, and a member of the American College of Physician Executives, the American Telemedicine Association, and the American Medical Association.
Very good news from PKTX this morning. This guy from SAIC is a true scientific heavyweight in the pharma industry.
What's your read on today's news and the outlook now ... and your Technical analysis?
Dear Folks...Again, another stone in place with this PKTX news.. Another heavy hitter added to the chain of command..(IMHO)Things are looking good down the road, hopefully sooner than later. Like Skyyy asked the other day, "Is anybody accumulating?" Got more shares?
Protokinetix..PR NEWS!!! PROTOKINETIX INC. (PKTX: OTCBB)
Vancouver, British Columbia, May 6, 2008
John S. Parker, M.D., Major General (Ret.) Appointed Chairman of ProtoKinetix’ Science Advisory Board
Protokinetix Inc. (PKTX) President and CEO, Ross Senior, is pleased to announce the appointment of Dr. Parker as Chairman of ProtoKinetix’ Science Advisory Board as key to expanding the medical applications of the company’s anti-aging glycopeptides (AAGPs™) and optimizing their commercialization.
“Our top priority is delivering our technology into medical applications,” commented Senior. “This means having a structure and the right people in place, with a clear mandate and a visible role, who can perform on both the medical science and business fronts. The strategic significance of bringing Dr. Parker into a leadership position emphasizes our commitment to this objective.”
ProtoKinetix’ top business advisor Edward D. Martin, MD, Rear Admiral (Ret.) U.S. Public Health Service, concurred with Senior, “Bringing in a senior medical expert like John Parker to lead our Science Advisory Board has positive implications at several levels. As Chairman of the Business Advisory Board I enthusiastically look forward to working with Dr. Parker as we fully integrate our science with the commercialization of our anti-aging glycopeptides.”
Parker stated, “ProtoKinetix’ AAGP has tremendous potential for multiple applications in mainstream medical science as well as military health care delivery systems. I embrace the opportunity and challenge of helping bring this breakthrough technology to the forefront of biotech industry and government efforts in blood, cell and tissue preservation.”
Dr. Parker joined Science Applications International Corporation as Senior Vice President in 2002 and has achieved the entitlement to be designated as a Technical Fellow and serve as the Chief Medical Officer in the Health Solutions Unit. Immediately prior to joining SAIC he served 37 years of service with the United States Army. His last assignment was Commanding General, U.S. Army Medical Research and Materiel Command and the Fort Detrick Installation Commander. Dr. Parker was responsible for the Army’s medical research, product development, technology assessment, rapid prototyping, medical logistics management, health facility planning and medical information management and technology.
Dr. Parker received a doctorate in Medicine from Georgetown University of Medicine in 1974 and a bachelor’s degree in Biology, Philosophy and Journalism from Washington and Jefferson College in 1963. He is a diplomate of the American Board of Surgery and the American Board of Thoracic Surgery, a fellow of the American College of Surgeons and the American College of Chest Physicians, and a member of the American College of Physician Executives, Chairman of the Advisory board of the National Functional Genomics Center and has been appointed to the National Biodefense Science Board by the Secretary of Health and Human Services.
Dear Folks...(IMHO) Either Bio-Tech summer doldrums are here and the "Day Traders" are making themselves known earlier than normal Or the M/M just want to drive the pps of PKTX down maybe per signing of a contract???
First, What a day for Protokinetixs(Friday, May 2nd!!!) Next beginning, it's the weekend, time for "OFF THE WALL" stuff...Like the "GAS PRICES" then you need to go to youtube.com and type in water powered car or water powered....Like to be pssssst off! Everybody, have a great weekend!! GO PKTX!!!
PKTX looks like a very strong buy here in the low .30's here now ... IMO.
The stock has consolidated in the low .30's after its last strong move up.
Any news developments off of publicly announced discussions with major pharma companies should pop this up over $1+ in the days to come.
Risk/reward equation looks great here now. There is great upside potential with very little down side risk from here now ... IMO.
Has anybody else here been accumulating more here at these low prices?
IMO ... we will see more than a triple from these levels before the year is out.
What are others targets here now?
Has anybody really sat down and read Dr. Edward D. Martin's Bio..He is one of a few new-bees added to Protokinetixs batting order...(IMHO)With the Big Pharmas and the FDA, pretty much running the show in the states.. PKTX would be slow coming out of the gates to show it's product..Dr. Martin has provided valuable advice to ProtoKinetix and has been instrumental in the introduction of AAGP(TM) to scientists and senior management in the health care industry...Read his bio profile, Protokinetixs is on the right track for success with this company
Dflem.. Protokinetixs, isn't your average, very day stock.. Yes, we have our flippers and day traders like others and have to admit PKTX is a two bladed sword... Just like the days in the past, on one side of the sword, PR News for this company has been very dry, to say the least..But on the other side, when PR News does come, it is usually something in capital letters and one more stone set in place for the big picture.. Summers for Bio-teches, it has been noted in the past, can be a little lazy(with the big $$$ on vacation)But with that said(IMHO)and at basically bargain pps, the information we have with PKTX.. It might be the best time to accumulate...And yes, PR News of an inking of a contract, will(IHMO)send Protokinetixs in to space..
Past and Present,
Your absolutly right in your statement, now all we need is PKTX to put the deal together. Without it were floundering, with it were $10.00. Need the deal.
With about every research group jumping on the bandwagon, Protokinetix(IMHO)will help greatly help with this snowball going down the hill research...(Sorry, old news).
Umbilical Cord Blood Industry Tests ProtoKinetix’ AAGP™
ProtoKinetix, Inc. (PKTX) announces that a top tier company in Umbilical Cord Blood Preservation has conducted preliminary tests using AAGP™ as a protective agent in the cryofreezing (-196°C) and subsequent thawing of cord blood units. The results, using a relatively small number of samples of cord blood and a low concentration of AAGP™ (4mg/ml) showed a 104% average increase over the control group (cells not treated with AAGP™) in the yield following thawing.
In addition, a post-thaw two week proliferation assay was performed to test the ability of cells to function. A 38% increase over the control group was observed. The importance of this is the ability to propagate additional stem cells, recovered from the cord blood, in order to provide adequate supply for therapeutic use.
Umbilical Cord Blood Preservation companies have a product offering through which families can preserve their baby’s umbilical cord blood at the time of birth. The cryopreservation of this cord can be saved for possible future medical use in the treatment of over 40-diseases, including blood cancers and genetic disease. Some Umbilical Cord Blood Preservation companies conduct Research and Development primarily to investigate other potential therapeutic uses of umbilical cord blood – derived stem cells and on technology for expanding populations of these cells.
Since a major loss of cells occurs in the transportation and storage of the cord blood before freezing, it has been suggested that AAGP™ be added to the cord blood bags before shipping. This could further assist in the increase of the viable cell population. ProtoKinetix is pleased to know that these findings are worthy of further investigation for commercial applications.
Cord Blood Bank At M. D. Anderson Cancer Center Receives $9 Million Grant
In a move that could dramatically increase the nation's supply of stem cells for transplantation, the Health Resources and Services Administration (HRSA), part of the U. S. Department of Health and Human Services, recently awarded a $9 million grant to the cord blood bank at The University of Texas M. D. Anderson Cancer Center. The three-year grant will fund the collection, processing and storage of umbilical cord blood at M. D. Anderson to be entered in the National Cord Blood Inventory (NBCI).
"This grant will allow our program to grow substantially and make a huge impact on the number of cord blood units available for transplantation," say Elizabeth Shpall, M.D., professor in the Department of Blood and Marrow Transplantation and director of M. D. Anderson's cord blood bank.
M. D. Anderson's cord blood bank, established in April 2005, has collected more than 1,900 cords to date through partnerships with the Woman's Hospital of Texas and Ben Taub General Hospital. Currently umbilical cords are collected from volunteer maternity donors 24 hours per day Mondays through Fridays at these sites. The additional funding will allow M. D. Anderson to increase its staff at each site to collect umbilical cords 24 hours a day, seven days a week. There are also plans to add a third collection site in the Houston area.
Bone marrow transplantation, which replaces a patient's diseased blood cells with healthy cells from a volunteer donor, has been the standard of care for selected high-risk patients with leukemia, lymphoma and other life-threatening blood disorders. In recent years umbilical cords have emerged as a rich and plentiful source of stem cells for transplantation.
Successful transplants of cord blood stem cells also replace a patient's diseased blood cells with healthy ones, but require a less precise tissue type match between the donor and recipient than do bone marrow transplants. This makes finding matches easier and reduces the wait some patients experience. Another benefit is fewer complications associated with graft-versus-host disease since cord blood stem cells are less mature than bone marrow stem cells.
The HRSA has a goal of collecting 150,000 new units of high quality cord blood from diverse populations, including minority populations. The program has a specific goal to collect more than 60 percent of these donations from minorities, according to Shpall.
"Our program will be a great asset to the National Cord Blood Inventory in part because of Houston's diverse ethnic population," says Shpall.
Historically, minorities have been the least able to find suitable matches among adult bone marrow donors because fewer minorities register as potential donors. Collecting more umbilical cords from minorities will boost chances for more matches for minority patients on transplant waiting lists.
In 2003, before M. D. Anderson began cord blood stem cell transplants, only 25 percent of stem cell transplant recipients at the institution were minorities, says Shpall. In 2004, when M. D. Anderson began using cord blood stem cells, that figure increased to 59 percent.
The HRSA funded five other cord blood banks, in addition to M. D. Anderson, including the Carolinas Cord Blood Bank Program at Duke University Medical Center, the Milstein National Cord Blood Program at the New York Blood Center, StemCyte, the University of Colorado Cord Blood Bank and the Puget Sound Blood Center.
Since the first successful cord blood stem cell transplant was performed in 1988 in France, more than 8,000 cord blood stem cell transplants have been performed worldwide.
PKTX Showing Some Life
As advised Apr.16....
Stem Cells
Summary
Stem cell transplants are routinely used to treat patients with cancers and other disorders of the blood and the immune system and may hold the key to repairing or replacing tissue cells damaged in many devastating diseases. Thus, proven and potential clinical benefit underpins the vast interest in stem cell research. Stem cells have both the capacity to self-renew (by cell division) and differentiate into mature, specialized cells. Differentiation describes a process of development with an increase in the level of organisation or complexity of a cell, accompanied with a more specialized function. During differentiation, certain genes become activated and other genes become inactivated in an intricately regulated fashion. As a result, a differentiated cell develops specific structures and performs certain functions.
This new report provides pharmaceutical companies with a clear assessment of opportunities and challenges presented to them by the stem cell market. It also provides vital insights into stem cell technologies and therapies that have already proven to be successful and analyzes those which have potential future value. The regulatory climate and proprietary landscape are discussed enabling you to formulate and optimize your stem cell strategies and position yourself for growth in this emerging market. Use this latest report to recognize areas poised for growth in the market for tissue repair and regeneration, identify potential alliance partners and plan a long-term growth strategy to secure your leading position in this market.
Key Features
· Growth forecasts for stem cell market sub-sectors to 2010.
· Examination of proprietary technologies and company strategies shaping the market for adult, embryonic and fetal stem cell products.
· Discussion of opportunities arising out of advances in hematopoietic stem cell transplantation.
· Analysis of global regulatory issues which are dictating where and how embryonic stem cell research is being done.
Key Findings
· The market for stem cell products and services is forecast to grow almost three-fold from $24.6 billion in 2005 to $68.9 billion in 2010.
· During the years 1980-2005, over 2,000 US patents claiming stem cell technologies and applications relevant to healthcare were published; the annual publication rate accelerated sharply in 2002.
· The proportion of stem cell patents claiming applications in hematology decreased after 1999, while the proportion of patents claiming applications in neurology, type 1 diabetes, cardiology and drug screening increased.
· Over 100 companies with proprietary human adult stem cell technologies and products have been identified.
The stem call market is emerging and growing rapidly as medical science continues to find more and better ways to use stem cells to solve life threatening disease. More and more parents are preserving umbilical cord stem cells of their newborn children for future use. The cost is around $3,000.
The safe and effective storage of stem cells is critical to the research and their use in health care. Stem Cells are stored through a process called cryopreservation at temperatures ranging from -37C to -87C.
Industry data indicates that only 20% survive cryopreservation.
Laboratory testing shows that healthy and safe storage of stem cells is significantly improved to close to 100% when AAGP™ is added to the cryopreservation process.
Put simply, more and healthier stem cells will be available for use at a later date when they are needed.
The market for stem cell products and services is forecast to grow almost three-fold from $24.6 billion in 2005 to $68.9 billion in 2010.
During the years 1980-2005, over 2,000 US patents claiming stem cell technologies and applications relevant to healthcare were published; the annual publication rate accelerated sharply in 2002.
The proportion of stem cell patents claiming applications in hematology decreased after 1999, while the proportion of patents claiming applications in neurology, type 1 diabetes, cardiology and drug screening increased.
Over 100 companies with proprietary human adult stem cell technologies and products have been identified.
Direct and Indirect Costs of Diabetes in the United States
(From American Diabetes Association)
The total annual economic cost of diabetes in 2002 was estimated to be $132 billion.
Direct medical expenditures totaled $92 billion and comprised $23.2 billion for diabetes care, $24.6 billion for chronic diabetes-related complications, and $44.1 billion for excess prevalence of general medical conditions. Indirect costs resulting from lost workdays, restricted activity days, mortality, and permanent disability due to diabetes totaled $40.8 billion.
The per capita annual costs of health care for people with diabetes rose from $10,071 in 1997 to $13,243 in 2002, an increase of more than 30%. In contrast, health care costs for people without diabetes amounted to $2,560 in 2002.
One out of every 10 health care dollars spent in the United States is spent on diabetes and its complications.
Direct Costs of Diabetes
· Estimated at $92 billion in 2002, compared to $44 billion in 1997.
· Diabetes alone represents 11% of the US health care expenditure. People with diabetes have medical expenditures 2.4 times higher than they would if they did not have diabetes.
· $40.3 billion was spent for inpatient hospital care and $13.8 billion for nursing home care for people with diabetes.
· Diabetes-related hospitalizations totaled 16.9 million days in 2002. Rates of outpatient care were highest for physician office visits, which included 62.6 million visits to treat persons with diabetes.
· Cardiovascular disease is the most costly complication of diabetes, accounting for more than $17.6 billion of the $91.8 billion annual direct medical costs for diabetes in 2002.
Indirect Costs of Diabetes
· Estimated to be $40 billion in 2002.
· In 2002, diabetes accounted for a loss of nearly 88 million disability days.
· 176,000 cases of permanent disability were caused by diabetes, at a cost of $7.5 billion.
Complications of diabetes in the United States
Heart disease and stroke
Heart disease and stroke account for about 65% of deaths in people with diabetes.
Adults with diabetes have heart disease death rates about 2 to 4 times higher than adults without diabetes.
The risk for stroke is 2 to 4 times higher among people with diabetes.
High blood pressure
About 73% of adults with diabetes have blood pressure greater than or equal to 130/80 millimeters of mercury (mm Hg) or use prescription medications for hypertension.
Blindness
Diabetes is the leading cause of new cases of blindness among adults aged 20 74 years.
Diabetic retinopathy causes 12,000 to 24,000 new cases of blindness each year.
Kidney disease
Diabetes is the leading cause of kidney failure, accounting for 44% of new cases in 2002.
In 2002, 44,400 people with diabetes began treatment for end-stage kidney disease in the United States and Puerto Rico.
In 2002, a total of 153,730 people with end-stage kidney disease due to diabetes were living on chronic dialysis or with a kidney transplant in the United States and Puerto Rico.
Nervous system disease
About 60% to 70% of people with diabetes have mild to severe forms of nervous system damage. The results of such damage include impaired sensation or pain in the feet or hands, slowed digestion of food in the stomach, carpal tunnel syndrome, and other nerve problems.
Almost 30% of people with diabetes aged 40 years or older have impaired sensation in the feet (i.e., at least one area that lacks feeling).
Severe forms of diabetic nerve disease are a major contributing cause of lower-extremity amputations.
Amputations
More than 60% of nontraumatic lower-limb amputations occur in people with diabetes.
In 2002, about 82,000 nontraumatic lower-limb amputations were performed in people with diabetes.
Dental disease
Periodontal (gum) disease is more common in people with diabetes. Among young adults, those with diabetes have about twice the risk of those without diabetes.
Almost one-third of people with diabetes have severe periodontal disease with loss of attachment of the gums to the teeth measuring 5 millimeters or more.
Complications of pregnancy
Poorly controlled diabetes before conception and during the first trimester of pregnancy can cause major birth defects in 5% to 10% of pregnancies and spontaneous abortions in 15% to 20% of pregnancies.
Poorly controlled diabetes during the second and third trimesters of pregnancy can result in excessively large babies, posing a risk to both mother and child.
Other complications
Uncontrolled diabetes often leads to biochemical imbalances that can cause acute life-threatening events, such as diabetic ketoacidosis and hyperosmolar (nonketotic) coma.
People with diabetes are more susceptible to many other illnesses and, once they acquire these illnesses, often have worse prognoses. For example, they are more likely to die with pneumonia or influenza than people who do not have diabetes
Dflem...By just looking at the management team, each of them with a specialty, not just a scientific research group anymore..(IMHO)I feel Protokinetixs has been ready.. With the AAGP research data PKTX has and the cosmetic companies doing their own research.. A few more dotting the "i's", and crossing the "t's.. We will have a contract, hopefully sooner than later and then to "DA MOON"...
Past and Present,
All this info is good, bottom line PKTX needs a contract. When that day comes, and I think it's soon, there is no ceiling on where the stock price will go. Let's just get a deal done.
NO, Protokinetixs is not doing stem cell research...But one of the bottlenecks in this rapidly expanding industry and ultimate commercializationis 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.
Interesting information..
The US Department of Defense has announced the launch of a five year collaborative program to make use of cutting edge medical technology to treat service members who are badly disfigured from injuries received while serving in wars.
Giving an example of the type of innovative treatment the new initiative would be developing, Lt Gen Eric Schoomaker, who is Surgeon General of the US Army told a press conference held at the Pentagon yesterday, Thursday 17th April, about one case of a badly burned Marine who was going to receive a new ear grown from his own stem cells.
Using the patient's own stem cells to regenerate replacement skin, tissue and other body parts is an area currently being explored by the new Armed Forces Institute of Regenerative Medicine (AFIRM) said Schoomaker.
AFIRM will come under the US Army's leading medical research, development and acquisitions agency for related supplies, the US Army Medical Research and Material Command at Fort Detrick in Frederick, Maryland, which ultimately reports to Schoomaker in his capacity as Army Surgeon General.
AFIRM will also collaborate with the US Army Institute of Surgical Research, based in in San Antonio, Texas.
Assistant secretary of defense for health affairs, Dr S Ward Casscells, who was also at the Pentagon press conference, said that AFIRM will be the operational agency for the initiative, where new ways of using a patient's own cellular structure to make new skin, tendons, muscles, and even noses, fingers and ears will be developed using stem cell technology.
The use of use of improvised explosive devices (IEDs) in Iraq and Afghanistan is the main reason for a marked increase in severe blast trauma, which now accounts for three quarters of all injuries.
Improvements in body armour, faster evacuation from the battlefield and advances in medical care now mean that more soldiers survive, but they face severe challenges from their injuries, which affect their limbs, their head, face, skin (from burns in particular), resulting in many years of treatment and often accompanied by lifelong disability.
Casscells said that just over 900 US military personnel have had limbs amputated from injuries received while serving in Afghanistan or Iraq, and there are also many who have other injuries like severe burns, loss of vision, and damaged spinal cords.
The assistant secretary said that AFIRM will play a major hand in getting these service members back to being fully participating members of society.
Explaining a little about the stem cell technology that the new effort will be developing, Schoomaker said:
"The cells that we're talking about actually exist in our bodies today."
Even in adulthood our bodies have a small quantity of cells that can be stimulated to become like stem cells, with the potential to become any one of a range of different cell types.
For the initial five year period, AFIRM will be funded by an overall budget of around 250 million dollars, 80 of which will come from the Department of Defense, and the rest from organizations like the National Institutes of Health, the Department of Veterans Affairs, and matching funds from other public and private organizations.
Also at the conference, and talking in a little more detail about the stem cell technology that will form the main part of the research and development work of the new initiative, was Dr Anthony Atala, a surgeon and director of the Institute for Regenerative Medicine at Wake Forest University, one of the partners collaborating with AFIRM, who said:
"All the parts of your body, tissues and organs, have a natural repository of cells that are ready to replicate when an injury occurs."
Cells can now be taken from human donors, taken through a series of scientific processes, and be used to regrow new tissue, said Atala.
"Then, you can plant that (regenerated tissue) back into the same patient, thus avoiding rejection," he added.
Two other universities are also participating in the initiative: Rutgers University, in New Jersey, and the University of Pittsburgh, in Pennsylvania.
Expressing his hope and optimism for the new initiative, Schoomaker said that salamanders can grow new tails and limbs to replace ones they have lost:
"Why can't a mammal do the same thing?" he asked.
Health Care
Acute medical problems are increasingly reliant on, and benefiting 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.
Health Care Applications of AAGP™ fall into two main categories
· Harvesting, storage and transplanting cells, tissues and organs
· Treatments for conditions and disease caused by stress factors, including UV radiation, oxidation and inflammation
The extent of the value of the ProtoKinetix family of AAGPs™ is being investigated by companies specializing in medical cell therapies, organ transplantation, trauma, blood product banking, anti- inflammation and skin care
What the heck... Now you want to raise the bar, just when I've been accumulating at a bargain.. Oh well, there goes the neighborhood...Next, you will be saying that there is PR News? Take care..
indeed, looks ready to pop
PKTX
ADI has a nice rounded bottom to it now and the stock appears ready for a bounce.
I hope everybody is having a great weekend.. If you haven't checked Protokinetixs web site out lately, it's pretty informative and they keep adding to it(Protokinetix.com)...I would like to feel we have a bargain(IMHO)at these share prices and yes, would like some PR News.. Just like days from the past, you get some news and then there is some dry times but you have to say we have a great team on deck, with their own speciality and don't have to learn it as they go..I know, I know.. Rome wasn't built in a day but we got "DA" team..When our ducks are in a row, we'll(PKTX) be like a snowball going down a hill in winter...Just getting bigger!
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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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