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Dear JDCA (Juvenile #Diabetes Cure Alliance) Part Two

hands-talking-1311915-640x480If you have no idea what’s going on, please read Dear JDCA Part One.

It will bring you up to speed (as quickly as 2500 words can), giving you the information regarding what the Juvenile Diabetes Cure Alliance thinks are the most likely “practical cures” for people with Type 1 diabetes and why their petition demanding JDRF and ADA to commit 30% of donations to “cure research” isn’t doing anything to help the diabetes community except cause deep fractures amongst us.

Part One covered the transplantation “practical cures” that JDCA believes we should all support with the intent to have these cures available by 2025.

Part Two below covers the devices and the immune system manipulation options they highlight.

Quick Recap

The Juvenile Diabetes Care Alliance states that they want a “practical cure” by 2025. JDCA’s Four categories of a “practical cure”:

  • Islet cell transplantation
  • A device that mimics the pancreas
  • Glucose-responsive insulin (“smart insulin”) ***Please note that none of the potential practical cures are of this type.***
  • Modification of the immune system (blocking, balancing, and/or retraining)

Every year, JDCA issues a report that tells potential donors which “practical cures” are more likely to pull ahead. Here are the 2014 “Potential Practical Cure Solutions,” found in the JDCA State of the Cure report. (2015 hasn’t been published yet, but expect it in the fall as in previous years).

For each,  I will provide you the basic info into what it is, where this is in terms of “potential” release into the community and who is funding it.

JDCA’s 2014 Potential Practical Cure Solutions (Part 2)

Device

Bionic Pancreas (iLet)

Boston University

– Boston, MA

What it is: 

Engineers from Boston University have developed a bionic pancreas system that uses continuous glucose monitoring along with subcutaneous delivery of both rapid-acting insulin (to lower blood glucose) and glucagon (to raise blood glucose) as directed by a computer algorithm. The bionic pancreas automatically makes a new decision about insulin and glucagon dosing every five minutes; that’s 288 decisions per day, 7 days per week, 365 days per year. (Artificialpancreas.org)

Where it is in the pipeline of “practical cure”:

According to Clinical Trials.gov, Phase III clinical trials will begin soon, with an estimated completion date of August, 2016. 80 participants will be in this trial. All clinical trials to this date have had favorable results.

If the pipeline is followed, commercialization is to be expected by 2018. The major issues will be funding and the FDA approval of stable glucagon provided by Xeris Pharmaceuticals.

 

Who is funding this “practical cure”?

Drs. Damiano and Russell do not work for a privately funded company. They work for universities. Funding is obtained through NIH grants and generous donations from private donors. JDRF did fund a portion of this research. 

There is currently no investment funding for future commercial agreement. Funding is being obtained through donations made through Boston University and Massachusetts General Hospital, private grants, and potentially NIH.

This is one “potential cure” that is fueled by direct donations from the general public.

If you are interested in donating to the Bionic Pancreas (iLet), you can do so here. 

If you want to learn more about the iLet, click here.


Modification of the immune system

BCG

Faustman Labs (Massachusetts General Hospital)

-Boston, MA

What it is: 

The BCG Human Clinical Trial Program is testing Bacillus Calmette-Guérin (BCG), an inexpensive generic drug, as a treatment for advanced type 1 diabetes.

…current research focuses on discovering and developing new treatments for type 1 diabetes and other autoimmune diseases, including Crohn’s disease, lupus, scleroderma, rheumatoid arthritis, Sjögren’s syndrome, and multiple sclerosis. (Faustman Lab website)

Where it is in the pipeline of “practical cure”:

A Phase II clinical trial which will last five years is being launched.

In the phase I clinical trial, which was published in the August 8, 2012, issue of PLOS Medicine, two injections of BCG spaced four weeks apart led to temporary elimination of diabetes-causing T cells and provided evidence of a small, transient return of insulin secretion. The phase II clinical study will include more frequent dosing over a longer time period to determine the potential of repeat BCG vaccination to ameliorate the autoimmune state and improve clinical parameters such as HbA1c, a marker of average blood sugar control. (Eureka Alert)

Here is the Clinical Trials.gov posting for the Phase II Clinical Trial. Please note that this is a double blinded trial. Neither the investigator nor the participant will know if they are being administered the BCG vaccine or saline injections over 5 years. 150 participants will be selected.

Earliest results will be in 2020. Please also be aware that a Phase III Clinical Trial must be conducted after successful results are shown, which can delay commercialization by several years if the Phase II Clinical Trial results show promise.

Who is funding this “practical cure”?

The Lee Iacocca Foundation gave Faustman Labs $10 million dollars initial funding for her Phase I trials and has also committed funding to Phase II trials. Faustman Labs estimates that Phase II trials will cost $25.2 million dollars.

This is one “potential cure” that is fueled by direct donations from the general public.

If you are interested in donating to Faustman Labs, click here. 

Note: Mike Hoskins of DiabetesMine/Healthline did a recent interview with Dr. Denise Faustman in March, 2015. It’s an important read.  During the interview, Dr. Faustman mentions that neither JDRF or Helmsley Charitable Trust has funded her, but that NIH, private supporters, Lee Ioacocca and others have chosen her research as their “practical cure.”


TOL-3021

Tolerion, Inc.

-Portola Valley, CA

What it is: 

TOL-3021, is a novel reverse vaccine that induces tolerance to the type 1 diabetes specific auto antigen proinsulin and thereby reduces disease activity.

Unlike conventional vaccines, which act to stimulate the immune system, the reverse vaccine TOL-3021 is designed to selectively suppress specific elements of the immune system that are inappropriately activated in type 1 diabetes. TOL-3021 contains an engineered DNA plasmid that expresses proinsulin, which is associated with the autoimmune-caused destruction characterizing type 1 diabetes.(Tolerion website)

Where it is in the pipeline of “practical cure”:

In 2013, a press release regarding TOL-3021 stated:

The Phase 2 study results reported in today’s edition of Science Translational Medicine1 demonstrated that TOL-3021 preserved pancreatic beta-cell function while reducing destructive disease-specific T-cell activity in patients with type 1 diabetes.

These promising Phase 2 data indicate that TOL-3021 may stop the destruction of pancreatic beta cells and improve the long-term outlook for patients with type 1 diabetes, even in adults with long-established disease. Based on these results, we are eager to test TOL-3021 in a larger trial with longer dosing beyond 12 weeks, and to assess whether it might slow or stop disease progression entirely in younger patients when administered before large numbers of beta calls have been destroyed.

Nothing in regards to clinical trials has been published since 2013. In 2013, an article regarding the Stanford researchers who conducted this trial stated:

There are caveats with the trial. For one, the vaccine must be studied in more humans and is years away from being considered for Food and Drug Administration approval. What’s more, in the study, the vaccine’s benefits tailed off a few weeks after its 12-week dosing schedule was stopped.

I have yet to find another announcement regarding a Phase III clinical trial or anything regarding this “practical cure” since 2013. 

Who is funding this “practical cure”?

Dr. Lawrence Steinman, the Stanford researcher who, along with other researchers involved with this project, founded Tolerion. Here’s what he had to say regarding funding:

I can’t give enough praise to Bayhill’s investors, the JDRF (formerly the Juvenile Diabetes Research Foundation) and well-known VCs on Sand Hill Road and the Bay Area.

(When I dug a little deeper, I found that the original name of this drug was BHT-3021 and the trial was funded by… JDRF in collaboration with Bayhill Therapeutics.)

Rights to the reverse vaccine technology and associated product pipeline have been licensed to Tolerion by Stanford University.

There is no public donation funding being requested.


Cyclosporine Omeprazole/Lansoprazole

Perle Bioscience

-Charleston, NC

What it is: 

Cyclosporine is a well-known immunosuppressant given as an anti-rejection medication after organ transplantation and for treatment of RA (rheumatoid arthritis) or psoriasis.

Lansoprazole is a proton-pump inhibitor. You might know it by its brand name: Prevacid.Omeprazole is also a proton-pump inhibitor. (Brand name: Prilosec.) It decreases the amount of acid in the stomach and is commonly used in treating heartburn and GERD (reflux).

In 2013, Chris Leach of Insulin Nation wrote an incredibly informative article about Perle Bioscience and their “practical cure”.  He gave a better overview than I ever could about this so I encourage you to read his work.

Where it is in the pipeline of “practical cure”:

On June 23, 2015, Perle Bioscience announced that a Stage 3 clinical trial was beginning with their drug combination – PRL001. Except…

This Phase III clinical trial is not for individuals with long-standing Type 1 diabetes. According to the ClinicalTrial.gov information, this trial is for newly diagnosed Type 1 diabetics aged 10 – 20 years old. The trials will not be conducted in the U.S.

For those with diabetes diagnosed more than 12 weeks ago, the only clinical trial data listed on ClinicalTrial.gov, there is simply a “This study is not yet open for participant recruitment.” It’s last update was October 3, 2013.

Perle Bioscience’s website gives this information regarding its pipeline:

PRL001

PRL001 consists of the combination of two previously approved therapeutic agents, each yielding their specific response on the body. In Vivo animal studies, the first product inside of PRL001 causes the regeneration of the patients own insulin producing pancreatic beta cells to start growing again. The second part of PRL001 lowers the body ability from re-attacking the newly formed insulin producing cells to essentially put the pancreas back to how it was functioning prior to diabetes. Both agents are taken orally and no injections are needed for this product. Perle Bioscience, Inc. holds the issued and pending US and IPC patents (see below for patents) for the new use of these agents in treating diabetes. PRL001 is starting multi-center Phase 3 human trials in early 2015.

PRL002

PRL002 is a novel peptide developed by Perle Bioscience, Inc., where in current in vitro and in vivo studies, is showing signs of high levels of regeneration of insulin producing pancreatic cells. PRL002 is made up of our novel Beta Regeneration Agent for Diabetes (BRAD) peptides. Currently PRL002 is in animal trials with the hope to have an IND application to the FDA in early 2016. Our hope is that PRL002 will be used for both type 1 and type 2 diabetes. Please sign up for our newsletter to stay up to date on our progress (signup from the bottom of any page).

There is no mention of the Phase III clinical trial for individuals with “existing Type 1 diabetes” on Perle Bioscience’s website. 

Who is funding this “practical cure”?

According to Motley Fool:

Perle is a privately held company, so no investments can be made here as of yet.


Tianhe Stem Cell Biotechnologies

Stem Cell Educator Therapy

-China

What it is: 

“Stem Cell Educator therapy” is the innovative technology developed by Dr. Yong Zhao that uses stem cells drawn from human cord blood to targets autoimmune diseases. Currently, Tianhe is focusing on the application of Stem Cell Educator therapy in diabetes. Our clinical data provide powerful evidence that Stem Cell Educator therapy can balance the immune system and lead to the regeneration of islet beta cells and improve metabolic control in long-standing diabetic subjects. This groundbreaking technology is taking steps towards the ultimate cure of diabetes and revolutionizing the treatment of other autoimmune-related diseases.(Tianhe website.)

Where it is in the pipeline of “practical cure”:

Clinical Trials.gov gives this information: Stem Cell Educator Therapy in Type 1 Diabetes was last updated in November, 2013 and is still stating that it is recruiting participants in China and Spain. Expected completion was September, 2014.

No additional information regarding trials and a “practical cure” has been listed on the Tianhe website. The latest clinical trial information discusses Stem Cell Educator Therapy for hair regrowth in Alopecia Areata patients. (April 22, 2015)

Who is funding this “practical cure”?

The Chinese government, according to the sponsorship information provided on Clinical Trials.gov. The Tianhe website is looking for investors, stating this as an enticement:

A huge marketing opportunity due to the global prevalence of diabetes: For instance, the total number of Americans living with diabetes will increase by 64% in 2025. Annual Medicare cost will increase by 72%, with $514 billion/year (72nd ADA report).

There is no request from the general public for donations.


Previous JDCA “Practical Cures”

file-1-3-1237622-640x640JDCA has published three reports, talking about the “cure” and which projects they believe fall under the guidelines. I’ve focused on the 2014 report (which is the latest), but what about 2013? 2012? (They began in 2011.)

2013

In 2013, here’s what they said were practical cures paths, because they were in human trials:

Still going…

Diabecell (Phase II) – I’ve listed the latest in Part 1.

Tianhe Stem Cell Educator Therapy (Phase II) – I’ve listed the latest above.

BCG (Phase II recruiting) – I’ve listed the latest above.

ViaCyte (Phase I) – I’ve listed the latest in Part 1.

Off the list in 2014…

Sitagliptin/Lansoprazole (Phase II) Note: collaborator listed on ClinicalTrials.gov is JDRF. Status listed now as “The recruitment status of this study is unknown because the information has not been verified recently. )

Monolayer Cellular Device (Phase 1) According to ClinicalTrials.gov, this study is still recruiting patients for one location in Belgium, but JDCA has dropped it from the 2014 list of practical cures.

2012

In 2012, here’s what they said were practical cures paths:

Still going…

Diabecell (Phase II) – I’ve listed the latest in Part 1.

BCG (Phase II recruiting) – I’ve listed the latest above.

Off the list in 2013 and 2014…

Sitagliptin/Lansoprazole

Monolayer Cellular Device

ATG/GCSF – This Phase II clinical trial  is no longer recruiting patients but is active (meaning they got enough participants). The work is still ongoing, but if you read the criteria, it was modified to say that the participants must have been diagnosed between 1 and 2 years before the start of the study, taking out the possibility for those with long-standing Type 1 to participate. The trial is called: Reversing Type 1 Diabetes After it is Established and is being run by University of Florida with grants from the Helmsley Charitable Trust and Genzyme.


My Scorecard for 2014 Practical Cures

Based on what JDCA says are “practical cures” and what I’ve researched, here is the likelihood that they will become commercially available by JDCA’s 2025 “deadline.”

Transplantation

VIACYTE – Phase I/II clinical trial right now. Estimated commercialization date of this product if Phase I/II is successful, a Phase III trial is conducted and successful and proceeds to FDA approval? Unlikely by 2025.  
DIABECELL – Phase I/IIa completed. No Phase III clinical trials listed in ClinicalTrials.gov. Estimated commercialization date of this product if there is a Phase III trial and it proceeds to FDA approval? Unlikely by 2025.
ßAIR BIO-ARTIFICIAL PANCREAS – Phase I/II clinical trial right now. Estimated commercialization date of this product if Phase I/II is successful, Phase III happens and is successful and proceeds to FDA approval? Unlikely by 2025.

Device

BIONIC PANCREAS (iLET) – Phase I/II completed and Phase III beginning soon. Estimated commercialization date of this product if  Phase III proceeds to FDA approval and Xeris Pharmaceuticals gets FDA approval for stable glucagon? Likely by 2018 (2019 if you’re hedging bets.).

Modification of the Immune System

BCG – Phase II clinical trial being launched, lasting five years. Estimated commercialization date of this product if Phase II and Phase III is successful, proceeding to FDA approval? Unlikely by 2025.
TOL-3021 – Phase II clinical trial completed, with results showing the benefits did not last longer than the 12 week dosing period. There are no Phase III clinical trials list. Unlikely by 2025.
CYCLOSPORINE/LANSOPRAZOLE – Phase II completed. No clinical Phase III clinical trial listed on clinicaltrials.gov for patients with existing Type 1 diabetes. Unlikely by 2025.
STEM CELL EDUCATOR THERAPY – Phase II clinical trial listed in 2013 and still recruiting. Estimated commercialization date of this product if Phase I/II is successful, a Phase III trial is conducted and successful and proceeds to FDA approval? Unlikely by 2025.  

Conclusion to this LONG Part 2…

paper-numbers-1236363-639x426What one organization thinks is a  cure isn’t always a cure to you. It’s easy for JDCA call out an organization for not doing enough for what they think is “cure research.”
It’s much more difficult to do so when you realize that everyone has a different (and in JDCA’s reports, showing an ever changing) idea of what a “practical cure” would mean. 
What is practical in 2012, 2013, and 2014 may not be practical in 2015. JDCA kept mentioning DRI’s BioHub, but never put it on the top list of their “practical cures,” but yesterday’s announcement that the first human subject to be implanted with the BioHub is off insulin. (Time will tell is this is successful in the long-term, but JDCA didn’t consider this a donation priority.)
What about “smart insulin?” What about the other closed loop AP trials? What about…. something we haven’t thought of yet? We don’t know what the young researchers in five years will present to major diabetes organizations (or the general public). Seed money comes from these large diabetes non-profits to new researchers who seek out grants to get them off the ground. What happens to these researchers if they don’t get the seed money?
Nothing. Literally. 
JDCA is cherry-picking (and finger pointing, but to what end remains to be seen). It’s their right and I’ve learned a lot about the different avenues to a “practical cure. ” (Hat tip to JDCA for sending me down the rabbit hole. I’m certainly better educated for it.)
We are ALL cherry-picking. It’s our right. But do it by doing the research and making smart, educated choices.
We are all in this together, despite differences in opinions about what a cure entails, who is going to provide it, and who should fund it. And most importantly, who speaks for you. (Here’s a hint… it’s not me or JDCA.) It’s my hope that you learned something about “cure research” and where YOU can get your information about cure pipelines so you can speak for yourself.
Thank you for reading all the way to the end. 

Dear JDCA (Juvenile #Diabetes Care Alliance)… Part 1

hands-talking-1311915-640x480Over the past few weeks, I’ve been seeing infographics produced by the Juvenile Diabetes Care Alliance (JDCA) regarding “cure research” and major diabetes organizations.

The infographic is not flattering, and like everything related to statistics, not entirely truthful. (JDCA even admitted in a post on FB that they made some “judgment calls” in their numbers.)

At first, I ignored the repeated posting in Facebook groups of how JDRF and ADA have not done enough to find a cure for us, but after a while, the bashing became nothing but a “I hate these organizations and I’ll never donate to them again. How dare they take our money and do nothing.

I spoke up and reminded individuals in those groups that there are MANY ways to use the donations raised through walks and rides and other fundraising opportunities, but that ALL of the donations were being used to help people with diabetes, whether it be for research or for support. (And I also reminded them that there was a marked absence in this infographic of where one should be donating…)

My opinion voiced, I went on my merry way, living my life with diabetes, until I got an unsolicited email yesterday from someone claiming to be an employee of JDCA, asking me to promote, on my blog and through social media channels, their petition to the major diabetes non-profits, DEMANDING that JDRF and ADA use 30% of all donations for “practical cure research” through my blog.

Thank you for the invitation, JDCA. I’m going to pass.

Instead, I’m going to take my blog and use it took peek into what your privately funded non-profit, founded by the CEO of Activision Blizzard Entertainment (and a parent of a child diagnosed with Type 1 diabetes at the age of 2) wants us to focus on, rather than telling us what JDRF and ADA isn’t doing.

magnifying-glass-1240025-639x397As I began writing this and hit 2500 words, I realized that this needs to be digested in more than one sitting, so I’m splitting this into 2 blog posts. (Mostly, because no one except masochists read 2500 words of my blog at a time and because I WANT YOU TO READ ALL OF THIS IMPORTANT AND UNBIASED INFORMATION.) Today, I’m covering just the Transplantation “practical cures” and you’ll get the others tomorrow in Part 2.

Juvenile Diabetes Research Alliance

According to a WSJ article, Mr. Kelly’s family foundation, the Brian and Joelle Kelly Family Foundation, has donated $1 million dollars (as of  the 2013 article stated) to JDCA. The goal of JDCA is to help donors “become educated about charities that are focused on a “practical cure” for Type 1 diabetes.

Note: Hey, I have no problem with the fact they have spent $1 million dollars to create a “watchdog” organization. They could have spent it on a boat or a house or funding one of their “practical cure” projects. If you’ve got money, you also have the right to spend it as you see fit. I also believe in watchdog organizations, as long as you provide factual, correct, public-facing information.

“Practical Cure”

The Juvenile Diabetes Care Alliance states that they want a “practical cure” by 2025. For their definition, a “practical cure” meets the following four criteria:

  • Minimal Monitoring (checking BGs less than once per week and a A1C between 5-7%)
  • Being able to sleep without worrying (about hypoglycemia or hyperglycemia)
  • Being able to eat whatever one wants without having to evaluate carbohydrate intake
  • Minimal side effects, understanding that some insignificant side effects are “acceptable”

Sounds reasonable, right? I’m all for that, because that elusive “don’t have to do anything ever again, it’s like magic and you don’t have to think about diabetes for the rest of your life” is a dream.

It then begs the question: What is JDCA’s idea of a practical cure?

JDCA’s Four Ideas of a “practical cure”:

  • Islet cell transplantation
  • A device that mimics the pancreas
  • Glucose-responsive insulin (“smart insulin”)
  • Modification of the immune system (blocking, balancing, and/or retraining)

Again, sounds reasonable, right? Some of these practical cures are beginning to look like they may not make the 2025 timeframe cut-off, but you never know, right?

Every year, JDCA issues a report that tells potential donors which “practical cures” are more likely to pull ahead. Here are the 2014 “Potential Practical Cure Solutions,” found in the JDCA State of the Cure report. (2015 hasn’t been published yet, but expect it in the fall as in previous years) – and I’m going to show you where the funding is coming from. 

JDCA’s 2014 Potential Practical Cure Solutions

These solutions are broken down by type of “practical cure” and gives you the basic info into what it is, where this is in terms of “potential” release into the community and who is funding it. (For my own personal curiosity, I have delved deeper into some than others.) As a reminder, Part 1 is ONLY transplantation. Part 2 is the rest of the “practical cures.”

Transplantation

VC-01

(ViaCyte – a privately held, for profit company)

-San Diego, CA

What it is (straight from ViaCyte’s website):

ViaCyte’s innovative product is based on the differentiation of stem cells into pancreatic beta cell precursors (PEC-01™), with subcutaneous implantation in a retrievable and immune-protective encapsulation medical device (Encaptra® drug delivery system). Once implanted, the precursor cells mature into endocrine cells that secrete insulin and other hormones in a regulated manner to control blood glucose levels. ViaCyte’s goal is a product that can free patients with type 1 and type 2 diabetes from long-term insulin dependence.

Where it is in the pipeline of “practical cure”:

ViaCyte, Inc. announced in July 2014 that it had filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence. This first-in-human trial will evaluate the safety and efficacy of ViaCyte’s VC-01™ product candidate, a stem cell-derived, encapsulated cell replacement therapy. ( Viacyte’s website)

They are in Phase I/II clinical trials at two locations, with an expected trial end date of August, 2017 with an estimated enrollment of 40 participants. Note: According to Wikipedia, “The percentage of Phase II trials that proceed to Phase III, as of 2008, is 18%.” Estimated commercialization date is unknown, but safe to say more than five years off.

Who is funding this “practical cure”?

JDCA forgets to include this:

JDRF is a major funder. 

ViaCyte has received substantial financial support from both the California Institute for Regenerative Medicine (CIRM) and JDRF. (Direct from the front page of ViaCyte website.)

Additional funders/partners include: Cellular Dynamics International, Invitrogen, now a part ofLife Technologies, Nestlé Institute of Health Sciences, Seventh Framework Programme, StemCell Technologies, Johnson & Johnson Development Corporation, Sanderling Ventures, Asset Management, BD Ventures LLC, Hospira, Inc., Portage Venture Partners, and The Clayton Foundation.

Note: What happens when/if it becomes commercially available? Janssen has signed an agreement with ViaCyte.

The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01™ combination product that ViaCyte is developing for type 1 diabetes. This right will continue through the initial evaluation of clinical efficacy of VC-01.  ViaCyte received $20 million from Janssen and Johnson & Johnson Development Corporation (JJDC).  The payment included a rights fee and a note convertible into equity at a later date.  JJDC has been a long-standing investor in ViaCyte.


 DIABECELL

(Living Cell Technologies – a multinational for-profit in a joint venture with DOL)

– New Zealand, Japan

What it is:

DIABECELL is an insulin-producing cell product derived from pigs for the treatment of type 1 diabetes. These islet cells are self-regulating and efficiently secrete insulin in the patient’s body.

The treatment involves introducing encapsulated pig cells into the patient’s abdomen in a simple laparoscopic procedure. Living Cell Technologies’ unique proprietary encapsulation technology prevents the islet cells from being attacked by the patient’s immune system. This allows the use of cell therapies without the need for co-treatment with drugs that suppress the immune system, which often have negative side effects.

Where it is in the pipeline of “practical cure”: 

To date, a total of 46 patients have taken part in clinical trials of DIABECELL. The goals of these trials have been to find the optimal dose required for DIABECELL and to obtain early indication of its effectiveness in controlling type I diabetes. These trials showed that DIABECELL has the potential to significantly reduce the number of unaware hypoglycaemic events that people living with Type I diabetes experience, whilst also reducing their insulin dose and not experiencing a rise in HbA1c.

DOL is now preparing for a larger Phase II/III study to more fully determine the frequency and extent of this benefit.(Taken from Diatranz Otsuka Limited (DOL) website.)

The clinical trial results for DIABECELL are located here.

Highlights:

Phase I/IIa safety study (Russia) – Two out of the eight trial patients discontinued insulin injections for up to 32 weeks. (The assumption being that after 32 weeks, they resumed insulin injections.)

According to Seeking Alpha, an investment media company: “Mostly, the results are more modest involving decreased insulin injections and significant reduction in unaware hypoglycemic events.”

There are currently no clinical trials offered through Clinical Trials.gov (a global trial locator). 

Who is funding this “practical cure”?

LCT is an Australian for-profit company with headquarters and operations located in New Zealand. They have a joint venture with Diatranz Otsuka Limited (DOL). In June of 2015, DOL announced:

Diatranz Otsuka Limited (DOL), is to concentrate its research and development activities in supporting the development of DIABECELL® in the United States. As a consequence, research, development and manufacturing of DIABECELL in New Zealand will cease and there will be a reduction of staff at DOL’s headquarters in Auckland.

Otsuka Pharmaceutical Factory, Inc. (OPF), DOL’s 50% shareholder, is full sponsor and funder of the US program, operating under and exclusive license from DOL for US development and commercialisation of DIABECELL. Since securing the license, OPF has made positive progress, establishing a solid partnership framework for the US development.

DOL’s know-how, research to date and clinical experience in pig islet transplantation will be actively combined with OPF’s global drug development expertise and these partnerships to further strengthen and expedite the US development program.

This alignment of DOL’s expertise with the US program is part of DOL’s previously announced commitment to focus on the US development and FDA approval of DIABECELL. Once registered in the US, DOL retains a royalty free right to commercialise the FDA approved product in the rest of the world.

And of greater interest, Seeking Alpha says of DOL:

Otsuka is a formidable Japanese company with an established presence for its products in the US. Most notably its Abilify antipsychotic drug (shared with Bristol-Myers Squibb (NYSE:BMY)) generated $6.5 billion in US sales in 2013 (a top 10 US drug). To show it is no shrinking violet, Otsuka is involved in a fight to keep out generic versions of Abilify by suing the FDA!

Here is the press release from OPF.

None of these companies are non-profits and expressly state that they will sell and commercialize this product. They have not requested funding for cure research from the public. 


 

ßAir Bio-Artifical Pancreas

Beta-O2 Technologies

– Tel Aviv, Israel

What it is:

The ßAir Bio-artificial Pancreas is a macrocapsule that contains islets of Langerhans, cells from pancreatic regions of the body that contain hormone-producing beta-cells. The macrocapsule provides a fully isolated environment for the islets to thrive. The islets in the bio-artificial pancreas replace the function of the endocrine part of the pancreas; i.e., the sensing of the level of glucose in the blood and the regulation of the production of insulin and glucagon as needed.

ßAir has the potential to ‘normalize’ the lives of people living today with type 1 diabetes. How? Of greatest importance, the ßAir bio-artificial pancreas eliminates the need for frequent glucose testing and insulin injections. Immunosuppressive therapy, which has many side effects, is also not required.

Note: as the ßAir device contains ‘living’ cells, the patient must commit to keeping them healthy. Once every 24 hours, the patient needs to refill the air in the device using a replenishing device which includes a dedicated injector. This guarantees that the cells will have the requisite oxygen supply to thrive and perform their insulin and glucagon production role.

Replenishing the device is performed by injecting oxygen into one of two ports implanted under the skin. The replenishing device is very user friendly, requires minimal technical skills for operation, and has very few possibilities for incorrect operation. The replenishing procedure takes just about two minutes. An alarm will trigger if something has gone wrong. (Beta O2 Website)

Where it is in the pipeline of “practical cure”:

Phase I/II clinical trial being conducted in Sweden. Last verified in December, 2014 with a study completion date of March, 2016. 8 people are to be enrolled in this study. No results have been reported.

Who is funding this “practical cure”?

JDCA forgets to include this:

JDRF funded this company in 2014 to help get this clinical trial going.

Here’s the list of additional investors. As of this time, there has been no appeal to the general public for donations.


 

My Conclusion from Part 1:

For all the talk about JDRF not helping to fund a “practical cure,” I’m here to show you that JDRF is helping. Perhaps not to the extent that JDCA deems acceptable.

Who is JDCA to determine how much is acceptable?

Their “survey” of 1,000 donors in 2014, conducted by a third party (but where did they get their donor responses? Ask yourself that as they didn’t publicly state it in their report) claims that 88% of donors want their donations to go to “cure research.” The questions were targeted to invoke “cure” responses.

And before you jump on me saying that I’m a shill for JDRF (or ADA, who hasn’t been mentioned by me yet)… be very aware of this fact:

I donate to one of the “practical cures” that JDCA touts.

I’ve asked others for their help in funding this “practical cure.” I also donate to other diabetes non-profits, some big and some small, because I know (from my own thirty-two years of T1 diabetes) that while

I would sell everything I own to have a cure, crawl across a minefield strewn with broken glass to not have this horrible disease haunt me

in the meantime, we need support and research for the complications from this disease.

Every time a parent complains about a school issue in the US, every time a child gets a T1 peer or mentor, every time a teenager goes to a summer camp where diabetes is the norm, every time a family member views their loved one’s BG graph on a device from miles away… those donations matter, too. 

Conclusion: DO. YOUR. OWN. RESEARCH. 

More information is coming in Part 2, including JDCA’s practical cure solutions: devices (1) and immune system modifications(4).

Don’t be surprised. Or disappointed.

I was told in 1983 there would be a cure in five years. I’ve waited this long. We’ll all be waiting a little longer.

* I have chosen not to link to JDCA’s website. On purpose. They’re easy to Google if you want to see what I did. I’ve linked to the deep dive stuff.


 

Got Twitter? Simply click this link to share this post. 

If only everything was that easy.


 

Diabetes Educators Resource Page

Thanks for attending the CFADE meeting on Saturday, September 12, 2015.

As I mentioned, here is the link to the presentation I gave so you could focus on interacting rather than frantically scribbling notes, hoping to get the information before going to the next slide. (I’ve been there. Done that. It’s ugly.)

The New Edge of Diabetes Technology

Here are some additional links that I mentioned during the presentation:

The “Cure”

This are the links to the articles I wrote about what is considered to be “practical cures” and where they are in the clinical trial pipeline. Patients may want to talk about when a “cure” is going to be available. These articles can help ease the blow.

Dear JDCA (Juvenile #Diabetes Care Alliance)… Part 1

Dear JDCA Part 2

The Cost of Diabetes (Technology)

This post breaks down how expensive supplies and medications can be – the focus is technology heavy. 

We talked about how expensive diabetes can be with insurance, but most of you know someone who has no insurance.

This post covers the bare minimum of what it takes to live with Type 1 diabetes and no insurance.

Co-pay and Patient Assistance Programs for US Diabetes Supplies and Medications

This is by far the most popular post on my blog, because nowhere else can you find all the information (with all the restrictions) in one place. It was updated in late August and even I was surprised at the expansion of some programs.

Need Help with U.S. Diabetes Supplies and Medications? UPDATED.

Diabetes Policy Advocacy

It’s easy. And I’m personally asking for your help.

Join (it’s free!) Diabetes Patient Advocacy Coalition (DPAC) to help raise awareness about diabetes policy (including getting reimbursement for diabetes educators!

Help Patients Connect with the Diabetes Online Community

Hope Warsaw wrote this great blog piece and connects you with the Diabetes Hands Foundation PDF that you can give patients. And here is the research that proves peer support is helpful.

Help Patients Connect Face To Face

The Diabetes UnConference  is the only multi-day psychosocial peer support idea exchange conference for all adults with diabetes. (And separate sessions for caregivers.)

There will be two in 2016: Las Vegas and Atlantic City.

Miscellaneous

Pumps

Medtronic

In the Know is a quarterly email publication specifically for diabetes educators: http://professional.medtronicdiabetes.com/diabetes-educators

Animas

Animas HCP section has a “patient forms” PDF section to help your patients.

http://www.animashcp.com/professional/other-professional

Tandem Diabetes

Patient Forms

http://www.tandemdiabetes.com/Support/Documents-and-Resources/

 

 

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