Promising Pancreate Creates New Islets

Under normal conditions, islets differentiate only during fetal development, when the pancreas is first powering up. When islets do form in adults, it is usually in response to pancreatic injury and stress.

| Sep 28, 2009

One thing that really frustrates people with diabetes mellitus is the biopharma industry's focus on treatments rather than cures. A cure is what the diabetes community wants, not another band-aid. So the existence of a biopharma company that calls itself "CureDM" is promising, and its first product, Pancreate, seems to be on its way to fulfilling that promise.

CureDM started with the information that in most cases, the mass of pancreatic islets drops by 80 percent in type 1 patients and 50 percent in type 2 patients. They also knew from recent research that the adult human pancreas contains an abundance of pancreatic progenitor cells. Like stem cells, progenitor cells have the capacity to differentiate. Unlike stem cells, however, they are not able to become any type of cell. Instead, they differentiate only into their "target" cell, in this case, islets.

In adults, however, pancreatic progenitor cells rarely make the change into islets. Under normal conditions, islets differentiate only during fetal development, when the pancreas is first powering up. When islets do form in adults, it is usually in response to pancreatic injury and stress.

Scientists knew this fact way back before insulin was discovered, when surgeons performed partial pancreatectomies on children with diabetes in hopes of triggering islet regeneration. Rather than hacking off pieces of pancreases, however, CureDM turned to the modern study of genes, called genomics, and proteins, called proteomics. Using these approaches, they were able to identify the key that unlocks the pancreatic progenitor cells, causing them to differentiate into islets. That key is Human proIslet Peptide (HIP), christened Pancreate by CureDM. 

HIP is a peptide, or small piece of a protein, made of 14 amino acids (the building blocks of proteins). It is a segment of a large protein that is created by a gene called regenerating islet-derived 3 alpha, or the REG3a gene. HIP stimulates the pathways that cause adult pancreatic progenitor cells to differentiate into functioning islets, fully equipped with alpha, beta, gamma, and delta cells. Because of the scarcity of the REG3a protein after fetal development, CureDM believed that a lack of HIP was the critical element preventing new islet formation, or neogenesis, in adults.

CureDM discovered that the sequence of amino acids in HIP is very similar among many species. When they made a three-dimensional model of the human REG3a protein, they found the HIP part is exposed on the outer surface of the protein, not folded deep within it, making it available to bind with the other proteins that go on to stimulate islet differentiation. And CureDM has successfully stabilized HIP to improve its availability in the body.  Recent studies indicate that the dose of HIP required to stimulate islet neogenesis may be 100 times lower than the concentration required by naturally produced HIP.

So far, HIP has been producing some hopeful results. In cultures of human pancreatic ductal tissue, treatment with HIP increases insulin secretion four-fold. In diabetic mice, it triples the number of islets, essentially reversing the disease. Diabetes-related biomarkers normalize in as few as 10 weeks, and diabetic animals no longer need extra insulin after only 21 days of treatment.

CureDM is currently completing the toxicological studies required before filing an Investigational New Drug application, or IND, for Pancreate. An IND is a request for permission from the FDA to administer an investigational drug to humans. The company expects to begin clinical trials in both type 1 and type 2 diabetes in early 2010.

Patients will probably take Pancreate once or twice daily for a number of months, during which time their insulin injections will be gradually eliminated as Pancreate stimulates islet neogenesis. Type 1 patients would require simultaneous treatment with an immune tolerance agent to protect the new islets from autoimmune attack. Type 2 patients could receive Pancreate along with existing therapies to boost their islet numbers, and patients with pre-diabetes could use Pancreate to alleviate the stress on their existing islets.

In recognition of CureDM's work with HIP, the company recently received the 2009 North American Excellence in Healthcare Product Innovation of the Year Award for diabetes mellitus therapeutics, presented by Frost and Sullivan.

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Categories: Beta Cells, Diabetes, Diabetes, Insulin, Islet & Pancreas Transplant, Type 1 Issues, Type 2 Issues


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Comments

Posted by Anonymous on 30 September 2009

Oh, my gosh, a ray of hope for type 2 diabetics. Much of the research for a cure has been focused on type 1, how ironic both types may be helped by this new treatment. I have only a few years left, I would love to be able to live without insulin shots and their side effects. How much easier to lose weight without taking insulin, especially as you get older. No shots, weight loss, an increase in exercise will all add to the quality of anyone's life. I will be awaiting further developments with this drug. Thanks to the people who put their research into finding a cure.

Helen Mueller

Posted by dorisjdickson on 30 September 2009

I don't get it. Why is this any better than any other current "cure" that ultimately generates beta cells. You still have to take immunosuppressants - steroids - which are very, very bad. And you can't take steroids forever. You eventually have to stop and then we'll just reject again.

Please stop coming up with "cures" that aren't cures. For a type 1 there is no cure that doesn't address why we reject the beta cells in the first place. Honestly, I think we're still at stem cells (of some form) that don't need immunosuppressants and that we won't just simply reject again.

But I'm often accused of being too logical and not emotional enough so ...

Doris J. Dickson

Posted by Anonymous on 30 September 2009

This article is an interesting read but the following sentence bothers me:

"Type 1 patients would require simultaneous treatment with an immune tolerance agent to protect the new islets from autoimmune attack."

This quote is telling me that you have to take anti-rejection drugs for the entire duration of your life. In the past I mentioned this before concerning the Edmonton Protocol, and I will say it again, anti-rejection drugs will destroy ALL of your vital organs.

You can be free of Diabetes but you will have other health burdens to keep you company.

This is not a safe method to treat Type 1 Diabetes and I will be "shocked" if the FDA approves this treatment.

My message to these researchers is: is this the best you got for the 21st century??? Then shame on YOU.

My suggestion is go back to your drawing board and devise a safer way of treatment.

Sincerely from a bitterly disappointed Type 1 Diabetic.

And the wait goes on.......

Posted by rodinsc on 30 September 2009

I agree with Doris.

If one has to continue taking immunosuppressants, then this is really not a cure.

John

Posted by Anonymous on 30 September 2009

I was thrilled until I read about taking immunosupressants. They are nasty and can open pandora's box. Count me out - I'll live longer with the shots

Posted by Seymour on 30 September 2009

First we crawl then we walk.

Posted by Anonymous on 1 October 2009

This sounds great if it keeps me from taking insulin and keeps my blood sugar under control. I hope to hear more about this in the coming months.

Posted by Anonymous on 1 October 2009

Yes, first we walk, then we crawl. I want a real cure as much as all of the rest of you. But in my 41 years of living with type 1, everything has improved slowly and over a long period of time. I remember back to one shot a day with a glass syringe, testing via clinitest acid tablets mixed into water and urine and never really knowing what my BG was. I now often wonder how I made it through those times without any complications to date. The glucometer and the pump are not a cure, but they're thousands of times better than what I used to have when I was young. A cure will come and let's hope it happens soon, but in the menatime I personally feel very privelaged to have the tools that I have today to better manage my diabetes.

Posted by dorisjdickson on 1 October 2009

Seymour, I'm afraid we're at the same place we were when I was diagnosed 11/2/76. How long do we have to crawl?

They can (and have been able to) get us to make more islets, beta cells, insulin but they can't tell the immune system to stay put.

I don't know of any healthy (no steroids) progress there. That tells me we still don't know the cause(s) of type 1 and that it is an imperative missing cog in the wheel.

I also am a firm believer in environmental causes (not food) - chemicals, etc. And who is going to have the audacity to say that? And then, are we permanently in immune overdrive? Is there a fix to that?

Thus, I focus on my own person responsiblity and fastidious care with the tools we have.

For me that means - testing 15 times a day, lots of small shots, an insulin cocktail, fewer carbs, normalized target as recommended by Dr. Bernstein, etc.

It's a choice but it keeps my limbs attached, my eyeballs working and my butt out of the ER. After 33 years, a cure would be nice but not much has changed if they can't fix our immune systems.

Doris J. Dickson

Posted by Lori on 1 October 2009

This is to Doris and the others who are not impressed with the progress for type 1. True: Pancreate alone is not a "cure" for type 1. False: To be "cured" with Pancreate, a type 1 patient will have to take traditional immunosuppression drugs. Pancreate stimulates your own islets (not to be confused with replacing islets with someone else's as is the case with transplants).

Therefore, to be "cured" with Pancreate will only require "Immune Tolerance" to your own islets - instead of full blow immunosuppression which is required when you have someone elses islets.

New immune tolerance drugs are on the way and they are only a once a year vaccine or treatment that does not kill off your entire immune system!! See Diamyd, Tolerx, Macrogenics, Develogen, Diakine for more on these. They are far more kind and will do the trick so Pancreate will work for type 1 as well as type 2. We are cheering them on!

Lori, a CureDM Founder

Posted by Lori on 1 October 2009

...and sorry it has taken so long. We just started working on this five years ago and it really took recent advances in genomics, proteomics and clinical science to make Pancreate a reality. Why did it take 5 years after that? Do you know how hard it is to scape together 5 million dollars? After the founders put in every possible cent, we had to find investors - which we are SO fortunate to have found. They are as critical as the science to making this happen. We hope they make alot of money because they deserve to as they took the leap of faith and believed in us.


Lori

Posted by Anonymous on 1 October 2009

While I agree that any treatment involving immunosuppressive drugs, such as neurotin inhibitors, mucophenolate mofetil, or prednisone, would be worse than the disease, what is being proposed here is immunomodulation, which is something different. Immunomodulation therapies usually employ various anti-CD molecules to modify but not globally suppress the immune system, so that it stops attacking pancreatic beta cells but still protects against other infections. Also, the side-effects are minimal compared to traditional immunosuppressives.

But the real problem with this proposal is that any stimulation of new growth of pancreatic beta cells at a period in the patient's life when they would not normally be growing carries a high risk of causing uncontrolled growth, which produces a deadly cancer known as an insulinoma. The risk of this happening has to be overcome before research efforts like the present can be considered worthwhile.

Posted by Anonymous on 2 October 2009

I wish you all the best in starting the clinical trials to test this peptide. I pray that this protocol will help and spur other scientists to try other new approaches, which may be kick-started with your science. Progress is made step by step,just as you are doing. I respect Lori's comment about how difficult it is to raise money for new research and commend the progress they have made. It takes trial and error to cure any disease or problem like diabetes. None of us learned to walk in a day, it took trial and error, but the persistence paid off. I understand the frustration of the "posters", but would remind them that the enemy is diabetes, not the researchers. It's difficult for me to understand how you can attack people who are trying to help. If anyone feels the need to attack anyone, I'd suggest looking at the pharmaceutical and insurance industry, who are motivated not to cure diabetes ever. What corporation wants to kill their "cash cow"? It pays the executives and lobbyists salaries and bonuses. So,please be kind to the people who are dedicated to helping cure diabetes. It's one baby step after another that will find the "cure". Rather than be negative, why not support each other in the fight to cure diabetes? If we don't band together, like AIDS and breast cancer advocates, who will?
My prayers are with you on behalf of my daughter who has diabetes sonce age 7 and for all people who suffer with diabetes. God speed!

Posted by Anonymous on 2 October 2009

I see mostly negative comments here and understand why. I am at least glad to know out there somewhere there are others with the same concern I have that no cure appears any closer than when my 7 year old son was diagnosed. He is now 45 and still no cure while the drug companies get richer and richer. They bring new products to market with costs that most of us can hardly afford even with insurance. I have been a type 1 diabetic for about 15 years. I have medicare Part B and D insurance and for more than half the year go into the gap and pay full price for my insulin and other meds. This takes a big chunck of my SS check. This is not acceptable. I believe the the drug companies do not want a cure found. Think how much money they will lose.

Posted by Anonymous on 3 October 2009

I have posted about this before, here and other places - get samples from your doctors. I too am in the donut hole; hopefully will not need to fill any more prescriptions between now and Jan. My insulin will continue to come from my endo, as well as my diovan. My lipitor and protonix both come from my pcp. I imagine not too many people ask for these as I have never been turned down. Think of it, without these samples I would have hit the hole in April! At the end of this year, it will be three years since I purchased insulin. Three years, just because I asked.

As for the upcoming cure, I hope there will be lots of samples and that I can slowly replace my insulins with this new product. The additional treatment for type 1s sounds very doable. Would taking these mild medications actually be worse than suffering lows in the search for tight control? I truly do not understand the negative viewpoints; this not quite a cure sounds a lot better than dealing with cannulas, pumps, insulin and devastating lows, not to mention blindness, kidney failure, lost limbs, etc. Helen Mueller, diabetes diagnosed in 1983, goes back much further than that.

Posted by Anonymous on 7 October 2009

Bravo CureDM!! ... I totally agree with Seymour, and I applaud Lori for actually engaging in the face of such negative comments(!) ... thank you, thank you, thank you for working TOWARD a cure.

Posted by Anonymous on 8 October 2009

I thought that insulinoma was a very rare type of pancreatic tumor. I don't know of any other therapies like Pancreate, so how can insulinoma be attributed to immunomodulation, which is also, I believe, a very new therapy, one not yet used for type 1 diabetes. Just asking.

Posted by Anonymous on 2 November 2009

Hey hopefully his will lead to a cure Bravo !

Posted by Jdubwordman on 3 February 2010

Baby steps are important!
About ten years ago a scientist used some sort of algae to create a coating for beta cells that would allow them to interact and secrete insulin. The holes in the coating were small enough to prevent the T-cells (immune cells) from recognizing and attacking the beta cells. He said then, that all we need to cure the disease is a way to mass-produce beta cells for transplant.
This pancreatic drug sounds like it could work. If we could take the drug, produce beta cells and remove them prior to destruction by the immune system (temporarily taking immunosuppressant’s might make this possible) then coat the beta cells with the protective coating and replace them back into the pancreas, the need for immunosuppressants would be eliminated and the disease would likely be cured.
Sign me up for that trial. 26 yrs of t-1 is 26 years too long.
Jeff

Posted by Anonymous on 11 March 2010

Wa Hoo. I'm up for this. How do we find out about the human trials? Big Pharma has made enough from their cash cow treatments. It is time for a cure!

Posted by Anonymous on 15 April 2010

Do you really think the drug industry is searching for a cure? Ther is not a better client than a child who will need insulin, or in this case other drug forever!!!


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