(last update: January 2011; partial update April 2011)
Let me give you the punch line up front: 69% of the treatments currently in human trials have been funded by JDRF. (And the number is 86% for the later phase trials!) This is an amazing impact; one that any non-profit should be proud of.
One new complication (which I am very happy to have!) is that there are now more studies which combine two different drugs into one treatment. In general, I give funding credit, if the organization in the past funded any component of a combination treatment, or if they are funding the current combined treatment. Also, I list experiments separately if they use at least one different drug. For example, There are currently about six different trials going on for Diamyd's GAD65, both phase-III and phase-II, however all of these are covered by the one listing in the phase-III section. However, the clinical trial using Diamyd's GAD65 and lansoprazole and sitagliptin together gets it's own listing, in the phase-II section.
Last year, I didn't think there were enough trials aimed at established (non-honeymoon) diabetics, to mark them separately, but this year, I think there are. The trials marked E/NH below include patients who have had type-1 diabetes for more than one year, and so are out of the honeymoon period. Other treatments might end up helping established diabetics, but these are the ones being actively tested right now. I was surprised at how many there are. There is a general belief that all the current clinical trials are for honeymoon diabetics, or that JDRF's funding is somehow only going to curing honeymooners. It is true that none of the phase-III studies are aimed at established type-1 diabetes, but phase-II contains 24% non-honeymoon trials, and phase-I contains 50% (with JDRF funding 71% of the non-honeymoon trials).
Remember: In the lists below, JDRF is not always funding the exact clinical trial listed, but they have provided significant funding for that line of research at some point. For example: JDRF is not funding Diamyd's phase-III trial or Diapep277's phase-III trial directly. However, JDRF did fund the early research into both of these treatments and so gets credit for them.
Cures in Phase-III Human Trials
Summary: there are 2, and all of the treatments have been funded by JDRF.
- Diamyd's GAD65
- Andromedia's DiaPep227
Cures in Phase-II Human Trials
Summary: there are 18, and 15 of them have been funded by JDRF, either directly or indirectly through ITN or TrialNet. Here are the treatments that have been funded by JDRF:
- Abatacept by Orban at Joslin Diabetes Center
- Canakinumab by TrialNet
- Diabecell by Living Cell Technologies (E/NH)
- Diamyd's GAD65 and lansoprazole and sitagliptin
- Exsulin (previously INGAP) by Exsulin (E/NH)
- Kineret / Anakinra by Mandrup-Poulsen at Steno Diabetes Center
- Sitagliptin and Lansoprazole ??
- Liraglutide at Hvidovre University Hospital (E/NH)
- PROCHYMAL by Osiris Therapeutics
- Rituximab by Pescovitz at Indiana
- Sitagliptin by Garg (E/NH)
- Sitagliptin and Lansoprazole at Sanford Health
- Thymoglobulin (also known as ATG) by Gitelman
- Umbilical Cord Blood Infusion by Haller at University of Florida
- Xoma 52 by Xoma Corp (E/NH)
- Atorvastatin (Lipitor) by Willi at Children's Hospital of Philadelphia
- Brod at University of Texas-Health Science Center
- NI-0401 by NovImmune
Cures in Phase-I Human Trials
Summary: there are 18, and 9 of the are funded by JDRF. Here is the list funded by JDRF:
- Alpha-1 antitrypsin (AAT) (by Omni ??)
- ATG and GCSF by Haller at University of Florida (E/NH)
- BHT 3021 by Bayhill Theraputics (E/NH)
- CGSF by Haller at University of Florida
- Trucco at Children’s Hospital of Pittsburgh (E/NH)
- IBC-VS01 by Orban at Joslin Diabetes Center
- Polyclonal Tregs by Gitelman (E/NH)
- Proleukin and Rapamune by Greenbaum at Benaroya Research Institute (E/NH)
- Lisofylline by DiaKine
- ATG and autotransplant by Burt at University of Sao Paulo
- Barium alginate microcapsules by Tuch (ACTRN12609000192280) (E/NH)
- BCG by Faustman at MGH
- CGSF and autotransplant by Esmatjes at Hospital Clinic of Barcelona (E/NH)
- Encapsulated Islets at University clinical Hospital Saint-Luc (E/NH)
- Etanercept (ENBREL) by Quattrin at University at Buffalo School of Medicine
- Monolayer Cellular Device by Université Catholique de Louvain (E/NH)
- Pioglitazone by Wilson at Stony Brook
- ATG and autotransplant by Snarski
Nor does it include a group of eight adult stem cell trials done mostly in private clinics, also discussed seperately.
Summary of all Trials
38 in total
12 not funded by JDRF
So about 69% of the human trials currently underway are funded (either directly or indirectly) by JDRF. Everyone who donates to JDRF should be proud of this huge impact; and everyone who works for JDRF or volunteers for it, should be doubly proud.
It is important to remember, however, that although there are two treatments in Phase-III trials, we are not close to a cure for established type-1 diabetes. None of the treatments in Phase-III trials resulted in cures during their Phase-II trials. They all extended or increased the honeymoon phase in some way.
We have a long way to go, and that is where JDRF comes in.
Discussion of Specific Research
- Leptin related research is not included, because I consider it aimed at better treatment for type-1, not an outright cure. This research may turn out to be very benefitial for people with type-1 diabetes, but I don't consider it aimed at a cure right now.
- The (E/NH) mark is given to any study that recruits patients who have had type-1 diabetes for more than 1 year, or which tests to ensure their patients are not generating their own C-peptide.
- I give an organization credit for funding a cure if it funded that cure at any point in it's development cycle.
- I use the term "US Gov" for all the different branches and organizations within the United States of America's federal govenment (so includes NIDDK, NIAID, NICHD, etc.)
- The ITN (Immune Tolerance Network) has JDRF as a major funder, so I count ITN as indirect JDRF funding.
- I have made no attempt to find out how much funding different organizations gave to different research. This would be next to impossible for long research programs, anyway.
- Funding of research is not my primary interest, so I don't spend a lot of time tracking down details in this area. I might be wrong on details.
- I don't work for the US Gov, JDRF, or any of the other organizations discussed here. I'm on the Research Information Committee of the San Francisco Bay Area chapter of the of JDRF and an adviser to JDCA. I also own stock in several of the companies discussed here.
Please think of this posting as being my personal "thank you" note to all the JDRF staff, volunteers, and everyone who donates money to research a cure for type-1 diabetes: Thank You!
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.