Monday, March 28, 2011

New Resource: Next Expected Milestone

I have the first draft of a new on-line resource for tracking research aimed at curing type-1 diabetes.  It is not in a "polished" form as yet.  I'm releasing it now partly because I think it will be very helpful, and partly so you can give me feedback on it.

I call it the Next Expected Milestone page.  It's permanent home is here:
But I've included the important part below.

My goal with this page is to make it easy, for each clinical trial, to see what research milestones are expected to be completed in the next month, season, year, etc.   On the one hand, this page can serve as an TLOD ("too long over due") list of research that isn't reporting the expected results.  On the other hand, it can tell you what announcements to especially look for in the next few months.

In the table below, the the important column is the last one.  It contains the next expected milestone the researchers should make.  So "Jun-2011 III Results !" means that in June of 2011, that trial should release their results, and the ! means they have publicly said they will do this.  "April-2012 II Started" means they will start a phase-II trial in April 2012, and so on.  Red dates are long over due.  Orange dates are slightly over due. and BoldGreen dates are coming up in the next few months.  All the columns in the table, and all the abbreviations and acronyms, are described in a section below the table.

Name          Id/Developer           Notes            Date Last Milestone        Date Next Milestone
Lisofylline   DiaKine                Inflam           May-2009 I Started         Dec-2009 I Complete
BCG           Faustman               Estab Comm       Jun-2010 I GotData         Oct-2010 I Results
Anakinra      NCT00645840            Inflam (Kineret) Jun-2010 I Completed       Dec-2010 I Results
Exsulin       Exsulin                Beta             Sep-2009 II Started        Nov-2010 II Complete
Atorvastatin  NCT00529191            (Lipitor)        Feb-2010 II Enrolled       Feb-2011 GotData
Etanercept    NCT00730392            (ENBREL)         Apr-2009 I Results         Apr-2011 II Start
GAD65*        NCT00723411 - EU                        Nov-2009 III Enrolled      Jun-2011 III Results!
Dendritics    NCT00445913            Estab            Feb-2011 I Enrolled[*]     Jun-2011 Results
Liraglutide   Hvidovre Univ Hosp     Estab            Jan-2011 II Complete       Jul-2011 II Results
AAT           Kamada                 Inflam           Mar-2011 I Paperwork       Aug-2011 I Starts
Anakinra      AIDA                   Inflam (Kineret) Jan-2009 I Starts          Sep-2011 I Complete 
BHT-3021      NCT00453375            Estab            Nov-2010 I Enrolled        Oct-2011 I Complete?
Xoma 52       Xoma Corp              Estab Inflam     Jul-2010 II Enrolled       Oct-2011 II Results
GAD65         NCT00751842 DIAPREVENT                  Nov-2010 III Enrolled     Oct-2011 III Complete 
DiaPep227*    DIA-AID1 NCT00615264                    Sep-2009 III Enrolled      Dec-2011 III Complete
Rituximab     Pescovitz at Indiana                    Dec-2009 II Publication?   Dec-2011 III Start?
Cord Blood    Haller                                  Mar-2009 II Started        Mar-2012 II Complete?
PROCHYMAL     Osiris                                  Jan-2010 II Enrolled       Apr-2012 II Results
Pioglitazone  NCT00545857                             Oct-2009 I HalfEnrolled    Jun-2012 I Complete
GCSF          NCT01102699            Estab            May-2010 I Started         Jun-2012 I Complete 
IBC-VS01      NCT00057499 Orban                       Jun-2010 I Published       Jun-2012 II Start
GAD65 [1]     NCT00837759            Estab            Jan-2011 II Enrolled       Oct-2012 II Complete 
GAD           NCT00529399                             Apr-2010 II Enrolled       Dec-2012 II Complete 
Sitagliptin   Garg                   Estab            Feb-2011 I Results         Feb-2013 II Start
GCSF          Haller                                  Apr-2008 I Start           Apr-2013 I Complete
ATG GCSF      Haller                 Estab            Apr-2010 I Started ?Aug    Apr-2013 I Complete
AAT           NCT01319331            Estab Inflam     Mar-2011 I Started         Sep-2013 II Complete 
Abatacept     Orban at Joslin                         Feb-2008 II Started        Sep-2013 Results
Proleukin Rapamune  NCT00525889      Estab            Nov-2010 I Enrolled        Sep-2013 I Complete?
NI-0401       NovImmune                               Aug-2010 II Started        Aug-2013 II Results ?
Rituximab     NCT01280682                             July-2010 II Started       Dec-2013 II Completed
DiaPep 277    DIA-AID2 NCT01103284                    May-2010 III Started       Mar-2014 III Complete
AAT*          RETAIN-1 NCT01183468   Inflam           Oct-2010 II FirstDose      Nov-2014 II Complete
Canakinumab   TrialNet               Inflam           Mar-2011 I Enrolled        Dec-2014 I Complete 
ATG           START NCT00515099                       Aug-2007 II Started        June-2015 II Results
Poly Tregs    Gitelman               Estab            Jan-2011 I Started         2016 I Results

[1] Combo trial including GAD65, lansoprazole, and sitagliptin

Understanding The Table

Each line is a separate clinical trial (so drugs/treatments with more than one trial active may have more than one line). 

The most common name of the drug or treatment.  Only one is included.  For drugs that have trade names and generic names, I usually use the generic name if there is space for it.  A * means this is the leading (farthest along) clinical trial for this drug or treatment in type-1 diabetes,  for treatments with many studies going on at the same time.

Should be an identifying number or trial name, or both.  However, I started out putting the name of the researcher here, and I'm only slowly replacing that with the US government's clinical trial number, or a similar number from another governmental organization.  Developer is the organization creating the treatment or testing it.  Only one is included.

Here are the notations in this field:
  • Appr: Drug or treatment already approved in the US or EU or both.
  • Beta: Drug or treatment aimed at increasing beta cell mass or efficiency.
  • Comm: A commonly used drug, so widely prescribed or not prescription at all.
  • Estab: A trial on established (non-honeymoon) type-1 diabetics.  Generally over 1 year.
  • Inflam: A drug or treatment based on preventing or lowering inflammation.
  • Prev: A trial aimed at preventing type-1, not curing it.
  • Treat: A drug aimed at treating type-1, not curing it. 
  • (...): A trade name of the drug in the trial, these drugs are usually "Appr".

Milestone Columns
The last two columns in the table are both milestones, and are very similar.  Here are the types of milestones listed in these columns: 
  • Paperwork: Filed the paperwork required to start a trial.  Usually either the clinical trial record, or the IND application, if in the USA.
  • Start: Started trying to enrolling patients in the trial.  Recruitment has started.
  • First Dose: The first patient actually enrolled and dosed.
  • Enrolled: Finished enrolling patients in the trial.  Trial is full.
  • Complete: The completion date from the clinical trial record.
  • GotData: Finished gathering data.
  • Results:  Important results published in some form (paper, symposia, abstract,etc.)
  • Published: Important Results published in a peer reviewed journal.
Also, these marks are used in both milestone columns:

  • "I", "II", and "III" refers to phases of clinical trials, and trials which the researchers consider phase-IV, are considered phase-II here.
  • A "?" means I need to recheck that date.
  • A "!" means the researcher or organization has publicly listed that date.
Last Milestone 
This column contains the date and content of this research's last milestone.

Next Milestone 
This column contains the date and content of this research's next expected milestone.

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.
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