Insulin Independence Revolutionary Phase 3 Trial Giving Type 1 Diabetics the Promise of a Needle-free Life

Charleston, SC (June 23, 2015) – Perle Bioscience, Inc. (www.perlebioscience.com) announces enrollment for the Insulin Independence Trial (IIT). This trial is the first and only Phase 3 trial to test a combination therapy in type 1 diabetics.

The end goal of the IIT will yield a medical breakthrough: insulin independence. The combination therapy will jumpstart the pancreas in type 1 diabetes patients so that the pancreas produces insulin and eliminates the need for insulin injections.

According to Dr. Claresa Levetan, Founder and Chief Scientific Officer of Perle Bioscience, “For patients with type 1 diabetes, the combination therapy patented by Perle Bioscience could end diabetes as we now know it. Our goal is to eliminate the need for patients with type 1 diabetes to receive insulin injections and the mission of Perle Bioscience is to have this become a reality.”

PRL001, the combination therapy drug in the IIT sponsored by Perle Bioscience, combines the usage of an immune tolerance agent and a therapy for pancreatic beta cell regeneration. Each therapy is already FDA (Federal Drug Administration) and EMA (European Medical Agency) approved. Both classes of therapies have been used in more than 1,000 patients with new onset type 1 diabetes, but never used together. This novel therapy is expected to result in the ability of the pancreas to produce insulin with new beta cells protected from immune attack.

“The ultimate goal is insulin independence, which means type 1 patients go back to producing their own insulin from their own pancreas,” says Dr. Ryan Fiorini, President & CEO of Perle Bioscience. “The success of this trial would result in a needle-free treatment, and will be life changing for those living with type 1 diabetes.”

The Insulin Independence Trial launches in Europe, with the goal of U.S. patient enrollment in a similar U.S. based trial based upon future FDA approval. Seven designated trial sites are located within Italy, with two additional sites to be scheduled outside of Italy. The lead trial site is in Rome at the Università Campus Bio-medico di Roma, and will be conducted by the trial’s lead investigator Dr. Paolo Pozzilli.

Perle Bioscience is a privately held research & development company. For more information on Perle Bioscience, please visit: www.PerleBioscience.com.

About Perle Bioscience:
Founded in 2013 by Dr. Claresa Levetan, Perle Bioscience is dedicated to finding original treatments for type 1 diabetes with the ultimate goal of eliminating the disease all together by novel approaches to beta regeneration. Perle has “composition of matter” patents for the discovery of novel human beta regeneration peptides. Perle’s total intellectual property portfolio (IP) comprises 12 issued and pending patents all in the diabetes space. Perle’s IP is established around the usage of novel proprietary peptides and proton pump inhibitors for beta cell generation combined with immune tolerance agents, with the ultimate goal of eliminating the need for insulin injections for the diabetes patients. To learn more, please visit us at www.PerleBioscience.com.

Hyperbole much?

EDIT: What I mean is I’ve been on this earth a long time with diabetes and have yet to see any “promising” research pan out with a true cure. It’s upsetting to see these pronouncements of “a cure”, when in fact, medical science is having a tougher-than-nails time grappling with this disease.

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Would insurance cover this? I think not for a long time. Medicare still does not cover a CGM. Just think how long CGMs have been sold. I do not get excited about these new innovations. You hear a lot about them, and then there is no more info.

There was a company making injectible forms of C-peptide. I read a lot about it for a few years, and there were successful human trials. Now I have not heard anything from them for a long while.

Dr Faustman’s vaccine to reverse type 1 is being tried on humans, but that has also been going a long time. Nothing really sounds that promising about any of these projects.

Maybe I am a pessimist, but I have been T1 for 69 years, and I have been hearing these promises for so many years. I am not paying much attention anymore.

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We did a live interview with the CEO of Perle Bioscience, Ryan Fiorini, just a few months ago, in which he talked about the work they’re doing. @phoenixbound and @Richard157, would you have any interest in having Ryan (or another representative from Perle) come back for another talk? It would give our community an opportunity to express the frustration you both mention here directly to someone involved in the work, and also ask questions like “will this be covered by insurance?”. I’d be happy to contact them for another interview, if there’s interest in the community :slight_smile:

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Speaking strictly for myself (naturally. lol), I don’t feel it productive to let my pessimism for a “cure” be conveyed to any researcher or the principals involved, because they will be inclined to defend their position and company (that a cure is in the works). For them to do otherwise would be bad form. I wish them well, but prefer not to keep seeing the “cure” headlines that crop up so often I lost count more than a decade ago. I’m not trying to shoot the messenger. I’m just sad to see so many research articles dash the hopes of diabetics who read such stories, when they don’t pan out. Typically, over years, each “cure” headline fades into oblivion, forgotten by most, only to be supplanted by the next “cure” story. wash and repeat.

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All I can say is: bring it on Perle! I will gladly be a lab rat for you when you get to the US (after all, RAT is part of my name, LOL!)

I vaguely remember something about this, weren’t there some issues with the C-peptide therapy side? How does the therapy get administered?

Wow! There are so many different solutions being pursued (AP with multiple players, BCG, ViaCyte beta cell encapsulation, Perle, who have I missed?) - exciting times.

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The only problem I have with the way that “cure” gets thrown around is when timeframes get put in place. We have all heard the “cure in 5 years” too much.

Associated with that is our sugar-normal friends assume that since they saw a headline about a cure and then they mentally cross diabetes off as something that STILL needs to have research performed.

Clearly, when researchers pursue their hypotheses and see what works and what doesn’t, it can be disheartening, but each of those “false” steps is ultimately beneficial, right?

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I would love to know more about what the treatment is specifically that will jumpstart the production of insulin.

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If this is the trial I think it is, the drugs used were a combination of Cyclosporin to shut down immune attack and, oddly, lansoprazole (Prevacid) to supposedly grow the beta cells.

Prevacid is a proton pump inhibitor (like Prilosec and Nexium). It is available over the counter and plenty of people with Type 2 use it. I have never heard of anyone reporting that their blood sugar improved while taking it, but who knows?

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I have a mild interest, but I think the people connected to these
experimental devices/cures/reversals/etc would just give us a big
promise, and not anything with real substance. I am bored with it.
Tell me the FDA has approved, and I will eagerly listen!!

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I’m surprised to see this is in Phase 3 trials. There have been plenty of unsuccessful attempts and false-hope, as previous commenters have pointed out, but by the time it reaches Phase 3, there is some credibility behind the attempt. Given that, I would have expected more publicity out of these folks.

Then again, maybe the motivated (and hopefully successful) researchers thrive on research and not publicity. We shall see.

I have been working on getting my immune system recalibrated for some time now…using primarily natural means like healing gut permeability and dysbiosis as well as supplements to support immune health.

Recently, I started taking low dose naltrextone. It works by blocking the receptor sites for endorphins (and opioids) for a few hours which stimulates the body to produce both more receptor sites and three times the amount of endorphins over the next 18 hours or so. The theory is that the flush of endorphins resets the immune system. There are studies where it has been effective with Krohn’s disease.

The way I will know if is working for me will be if thyroid antibodies go down in my body…which will mean the autoimmune attack is no longer occurring. In 2010, it was proven that alpha cells do convert to beta cells…once the autoimmune attack is ended that should be all she wrote, I figure.

I am always skeptical of drugs. It took me a lot of research to convince myself that low dose naltrextone wasn’t toxic in some way to my body…so I will watch and wait on this study, I think :wink:

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“Giving Type 1 Diabetics the Promise of a Needle-free Life”

Honestly, this kind of headline drives me a little nuts. I had to check that the title of the post was taken from the Perle Bioscience article (it was: http://www.prnewswire.com/news-releases/insulin-independence-revolutionary-phase-3-trial-300103526.html) because it actually would have surprised me if someone on this site–let alone one of the Leaders–would have stressed that aspect. Needles needles neeedles–ewwwwww!!!

Ok, I understand that this actually is a big deal to some T1s, especially young ones, and even more so to their parents. But I mean, it’s really kind of crazy. If–IF–this therapy or any other actually does cure the disease, that is to say, eliminate the kludgy insanity of trying to exercise manual control over your endocrine system that we’re all stuck with, the fact that NEEEEEEEEEEDLES!!! will no longer be involved is so far down the list of benefits that would bring that I really don’t know whether to laugh or cry when I read a title like this. The one thing I do know is that it’s not targeted at me, as a type 1 diabetic. I realize the general public is fixated on this aspect of the disease, but seriously, given all the crap you have to deal with 24/7/365 to try to stay aboard this wobbly bicycle of a disease, I have to say that “Ouch, I had to stick myself with something sharp again,” is SOOOOOO far down the list of concerns that, well, like I say, I don’t know whether to laugh or cry. If all the shots & finger sticks and infusion set insertions and whatnot were actually making my pancreas function identically to a normal one, would all that skin puncturing bother me? Not in the least. It’s not the needles, it’s the failure-prone Rube-Goldbergian complexity of the whole mess that’s the problem.

Ok, rant over.

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@Ahnalira, check out the live interview I did with the CEO of Perle last spring: http://www.tudiabetes.org/video/tudiabetes-live-interview-with-dr-ryan-fiorini-perle-bioscience/

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How long have you been injecting insulin?

Thirty one years.

DrBB, im so with you on the normals and medical professionals thinking the needles are the worst part. when my labs came back a couple of weeks ago without my a1c done, my doctor shook her head while she said, oh it was a shame, now theyll have to stick you again.
being stuck and sticking myself (again and again and again) is the EASIEST part of this disease. we dont need the cure so we can stop sticking ourselves, we need the cure so we can stop thinking about diabetes ALL THE TIME!

this little patch would be great. smart insulin would be great. a closed loop system would be great, anything so i can stop THINKING about this!

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I have been a Type 1 diabetic for 58 years. After 52 years of thousands of injections, I became needle-phobic. The OUCH you think is minor to you is not minor to millions of others. I cut down on my insulin shots to one-a-day with Lantus and Exubera inhaled insulin until they took it off the market. I thought that was a great improvement at the time.

Spent 5 1/2 years in a research study trial using AFREZZA inhaled insulin. I have not had to take an insulin injection during those 5 1/2 years. Believe me, I know that is not a cure. But for now it is the best out there for those of us struggling physically and emotionally with injections.

AFREZZA is now available [with a prescription] in local drug stores. And no, I do not work for or have stock in Sanofi.

ML

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Well I’d never accuse anyone of that. Like I said, I understand that this is a big deal for some, as it obviously is for you. But I think a lot of us feel the way I do as well. One of the things about Afrezza specifically is that it has a number of benefits that I remained pretty much ignorant of for a long time because all the headlines stressed the “no needles” thing, and for me personally that one aspect is not particularly salient. I actually am interested in trying it myself because of the faster action, shorter “tail” and decreased severity of hypo reactions people seem to have with it. But all of that tends to get buried under the one part of it that–again, for me personally–isn’t the most important thing. I know it’s just the media being the media–this is the thing that freaks most people out about T1–but to me it’s just one of the ways I feel alienated from the non-T1 world when it turns its attention our way.

Anyway, no hard feelings–we all have different experiences with the disease and don’t need to agree about everything. And congratulations on surviving 58 years with T1. I hope to be able to say the same some day.

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Thanks for your reply.

I agree, being a Type 1 diabetic for over 57 years tends to dictate everything about our lives. EVERYTHING my husband and I do is scheduled around my diabetic condition. You are right, non-diabetics tend to think taking a shot is almost a cure.

ML

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