Monday, September 13, 2010

JDRF Funding Research for a Cure 2010

Note: I forgot one study in the original (Sept-13) version of this blog entry, but this updated (Sept-15) version includes that study and updates the counts and percentages.  I'm sorry for the oversight.

In the US, we are starting the "Walking Season" when JDRF asks us to walk to raise money for cure. So I'd like to do my part, by reminding you all how important JDRF is to the human trials of potential cures for type-1 diabetes, which I track. 

Let me give you the punch line up front: 73% of the treatments currently in human trials have been funded by JDRF. (And the number is 85% 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 37% non-honeymoon trials, and phase-I contains 50% (with JDRF funding 81% of the non-honeymoon trials).

Cures in Phase-III Human Trials
Summary: there are 4, and all of the treatments have been funded by JDRF.
  • Diamyd's GAD65
  • TolerRx's CD3
  • MacroGenics's CD3
  • Andromedia's DiaPep227 
All of these treatments have more than one study active right now.

Cures in Phase-II Human Trials
Summary: there are 16, and 13 of them have been funded by JDRF, either directly or indirectly through ITN. Here are the treatments that have been funded by JDRF:
  • Abatacept by Orban at Joslin Diabetes Center
  • 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
  • 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)
Not funded by JDRF:
  • 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 13, and 7 of the are funded by JDRF and 6 are not. Here is the list funded by JDRF:
  • 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
  • Proleukin and Rapamune by Greenbaum at Benaroya Research Institute    (E/NH)
  • Lisofylline by DiaKine
Not funded by JDRF:
  • ATG and autotransplant by Burt at University of Sao Paulo
  • 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
  • Pioglitazone by Wilson at Stony Brook 
This summary does not include Artificial Pancreas research, which I discuss separately.
Nor does it include the last group of eight stem cell trials.

Summary of all Trials
33 in total
9 not funded by JDRF
So 73% 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 four 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.
    Compared to Last Year

    In 2009 there were 4 treatments in Phase-III trials, in 2010 there are 4 (no growth).
    In 2009 there were 10 treatments in Phase-II trials, in 2010 there are 16 (growth of 60%, but see the discussion below).
    In 2009 there were 13 treatments in Phase-I trials, in 2010 there are 13 (no growth).

    Obviously, there is not the same level of growth as there was last year.  I'm not sure if that is because last year had unusually large growth, or if this year has unusually small growth, or if we are hitting "equilibrium" in our clinical trials of possible cures.   I'll discuss that in more detail in a future post, as time permits.

    Another issue, is that the growth in phase-II trials is partly due to my including several clinical trials of drugs which are used to treat type-2 diabetes and are being tested on type-1 diabetes.  Some of these drugs have shown success at lowering insulin requirements for type-1 diabetics, but I'm not sure if they are possible paths to a cure.  They may just be better treatments.  My plan on these is to wait about 9 more months and make a decision at that time if they are possible cures or just possible treatments.  If they are not cures, I'll remove them from my comparison.  The studies in this group include:
    • Liraglutide at Hvidovre University Hospital
    • Sitagliptin by Garg    (E/NH)
    • Sitagliptin and Lansoprazole at Sanford Health 
      • 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.
      This is an update and extension to blog postings that I've made for the last two years:

      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!

      Joshua Levy
      All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.

      No comments: