Saturday, October 1, 2011

JDRF Funding Research for a Cure 2011

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: 59% of the treatments currently in human trials have been funded by JDRF. (And the number is 76% for the later phase trials) This is an strong impact; one that any non-profit should be proud of.

As you read the list below, please remember that it is a list of possible treatments, not a list of trials. Some of the treatments below have several different trials on-going right now.  Also remember that I give an organization credit for funding a treatment if they funded it any any point in development; I don't limit it to the current trial.  For example, JDRF is not funding the current trials for DiaPep277, but they did fund much of the early research into it, which allowed it to grow into human trials.

Cures in Phase-III Human Trials
Summary: there is only one treatment in phase-III right now, and it has been funded by JDRF.
  • Andromedia's DiaPep227 
This treatment has more than one study active right now.

Cures in Phase-II Human Trials
Summary: there are 16, and 12 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    (Established)
  • Diamyd's GAD65 and lansoprazole and sitagliptin
  • Exsulin (previously INGAP) by Exsulin    (Established)
  • Kineret / Anakinra by Mandrup-Poulsen at Steno Diabetes Center
  • Liraglutide at Hvidovre University Hospital   (Established)
  • PROCHYMAL by Osiris Therapeutics
  • Rituximab by Pescovitz at Indiana
  • 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  (Established)
Not funded by JDRF:
  • Atorvastatin (Lipitor) by Willi at Children's Hospital of Philadelphia
  • Brod at University of Texas-Health Science Center
  • Canakinumab by TrialNet
  • NI-0401 by NovImmune

Cures in Phase-I Human Trials
Summary: there are 20, and 11 of the are funded by JDRF and 9 are not. Here is the list funded by JDRF:
  • Alefacept by TrialNet
  • AAT or Alpha-1 antitrypsin by OmniBio and also Kamada
  • ATG and GCSF by Haller at University of Florida    (Established)
  • BHT 3021 by Bayhill Theraputics   (Established)
  • CGSF by Haller at University of Florida
  • Trucco at Children’s Hospital of Pittsburgh    (Established)
  • IBC-VS01 by Orban at Joslin Diabetes Center
  • Leptin by Garg at University of Texas
  • Polyclonal Tregs 
  • Proleukin and Rapamune by Greenbaum at Benaroya Research Institute    (Established)
  • Lisofylline by DiaKine
Not funded by JDRF:
  • ATG and autotransplant by Burt at University of Sao Paulo
  • BCG by Faustman at MGH (Established)
  • CGSF and autotransplant by Esmatjes at Hospital Clinic of Barcelona  (Established)
  • Encapsulated Islets at University clinical Hospital Saint-Luc    (Established)
  • Etanercept (ENBREL) by Quattrin at University at Buffalo School of Medicine
  • Monolayer Cellular Device (Established)
  • Rilonacept by White at University of Texas
  • The Sydney Project, Encapsulated Stem Cells (Established) 
  • Pioglitazone by Wilson at Stony Brook 
This summary does not include Artificial Pancreas research or stem cell trials, which I discuss separately.  The list above is a list of treatments, not a list of trials.  For example, the "ATG and autotransplant" treatment is actually running two trials (that I know of) one by Burt and another by Snarski, but since they are testing the same treatment, it is only one item in the list.  DiaPep277 is running several trials, Rituximab has two, and so on.  Each treatment gets one entry in the list, not each trial.  Finally, those treatments marked "(Established)" have at least one trial which is open to people who have had type-1 diabetes for over a year.  So those are open to non-honeymoon diabetics.

Summary of all Trials
37 in total
22 funded by JDRF
So 59% 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.

Just Looking at Trials on Established Type-1 Diabetics
13 in total (35% of all trials)
8 funded by JDRF (61%)
So 61% of the trials recruiting established type-1 diabetics, are funded by JDRF.

Compared to Last Year
In 2010 there were 33 treatments in clinical trials, in 2011 there are 37 (growth of 12%)
In 2010 there were 4 treatments in Phase-III trials, in 2011 there is 1 (major drop: -75%).
In 2010 there were 16 treatments in Phase-II trials, in 2011 there are still 16 (no change).
In 2010 there were 13 treatments in Phase-I trials, in 2010 there are 20 (big growth: 54%).

The big change this year is that 3 out of 4 phase-III trials have ended in failure.  That big, bad news.  The other side of the coin is that there are 7 new phase-I trials, but it's still a loosing trade off. The basic trade off is that -- on average -- starting 4.5 phase-I trials will eventually result in 1 phase-III trial.  So we gained the equivalent of about 1.5 phase-III studies, but lost 3. 

The following two drugs might turn out to be treatments rather that cures, but right now it's not know how they will turn out, so I'm still tracking them as possible cures:
  • Liraglutide at Hvidovre University Hospital
  • Sitagliptin and Lansoprazole at Sanford Health 
And finally, the Sitagliptin-only trial which I was covering as a possible cure last year, I now think is a treatment, so I'm removing it from the list of possible cures.
    How I Count Trials for This Comparison
    • I give an organization credit for funding a cure if it funded that cure at any point in it's development cycle.
    • I mark the start of a research trial when the researchers start recruiting patients (and if there is any uncertainty, when the first patient is dosed).  Some researchers talk about starting a trial when they submit the paper work, which is usually months earlier.
    • For trials which use combinations of two or more different treatments, 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.
    • 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 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.)
    • I don't work for the US Gov, JDRF, or any of the other organizations discussed here. I'm 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 three 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!

    Finally, if you see any mistakes or oversights in this posting, please tell me!  There is a lot of information packed into this small posting, and I've made mistakes in the past.

    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.  My blog contains a more complete non-conflict of interest statement.
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    1 comment:

    LarConBri said...

    Great article. I share the big thank you spirit, though I have not swallowed the fact the JDRF does not fund Faustman and I also dislike the too naive "industry partnership" approach.