Next Expected Milestone

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Last update: October-2011
 

The Next Expected Milestone for Each Clinical Trial

The annotations on the table below are fully described at the bottom.  The the important column is the last one.  It contains the next expected milestone the researchers should make.  So "June-2011 III Results !" means that in June of 2011, they should release the results of their phase-III trial, 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.



Name          Id/Developer           Notes            Date Last Milestone        Date Next Milestone
Lisofylline   DiaKine NCT00896077    Inflam           May-2009 I Started         Dec-2009 I Complete
Etanercept*   NCT00730392            ENBREL           Apr-2009 I Results         Apr-2011 II Start
Dendritics    NCT00445913            Estab            Feb-2011 I Enrolled       Jun-2011 Results
Liraglutide*   NCT00993720            Estab            Jan-2011 II Complete      Jul-2011 II Results
Anakinra      AIDA NCT00711503       Inflam Kineret   Jan-2009 I Starts         Sep-2011 I Complete 
Xoma 52       Xoma NCT00998699       Estab Inflam     Jul-2010 II Enrolled      Oct-2011 II Results
Exsulin       Exsulin                Estab?           Apr-2011 II Complete      Oct-2011 II Results
Cord Blood*   Haller                                  Oct-2010 II Enrolled       Oct-2011 II 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?
BCG           Faustman               Estab Comm       Jun-2011 I Results        Dec-2011 I Publication
LCT           LCT                    Estab            June-2011 II Started      Dec-2011 I Entrolled
BHT-3021      NCT00453375            Estab            Jun-2011 I Complete       Dec-2011 I Results
PROCHYMAL     Osiris                                  Jan-2010 II Enrolled      Apr-2012 II Results
Pioglitazone  NCT00545857                             Oct-2009 I HalfEnrolled   Jun-2012 I Complete
GCSF          NCT01102699 Padova     Estab            May-2010 I Started        Jun-2012 I Complete 
IBC-VS01      Orban NCT00057499                       Jun-2010 I Published      Jun-2012 II Start
AAT*          Kamada NCT01304537     Inflam           Jun-2011 I Starts         Oct-2012 I Complete
GAD*          NCT00529399                             Jul-2011 II Published      (Failure?) 
Sitagliptin** Garg NCT01227460       Estab            Feb-2011 I Results        Feb-2013 II Start
Alefacept     T1DAL NCT00965458                       Mar-2011 I Started        Mar-2013  I Enrolled
GCSF          Haller                                  Apr-2008 I Start          Apr-2013 I Complete
ATG GCSF      Haller                 Estab            Apr-2010 I Started ?Aug   Apr-2013 I Complete 
Anakinra*     NCT00645840            Inflam (Kineret) Apr-2011 I Results       Apr-2013 II Starts
AAT           RETAIN-1 NCT01183468   Inflam           Jul-2011 I Enrolled     Jul-2013 I Complete
AAT           NCT01319331            Estab Inflam     Mar-2011 I Started        Sep-2013 II Complete 
Abatacept     Orban at Joslin                         Sep-2011 II Published     Sep-2013 III Started
Proleukin Rapamune  NCT00525889      Estab            Nov-2010 I Enrolled       Nov-2012 I Complete[2]
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-2 NCT01183455   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
[2] Might be done one year earlier.
* Note to self:  Self, get blogging on these! 
** Note to self: Need to double check status on this trial and/or related trials.


These are prevention trials:


Name          Id/Developer           Notes           _Date Last Milestone       Date Next Milestone
Teplizumab    TriaNet                Prev             2011 II Starts            2016


These are more treatments, than cures:

Name          Id/Developer           Notes            Date Last Milestone       Date Next Milestone 
Sitagliptin   Garg                   Treat Comm       Mar-2011 II Halfdone      Dec-2011 II GotData?
Sitagliptin[2] Stanford              Treat Comm       Sept-2010 II Starts         April-2014 Complete
Sitagliptin[2] Stanford 

[2] Sitagliptin and Lansoprazole




From here down are rough notes, which I will move up over time.

Barium alginate microcapsules by Tuch (ACTRN12609000192280)  (E/NH)                Phase-I
Encapsulated Islets at University clinical Hospital Saint-Luc    (E/NH)             Phase-I
Monolayer Cellular Device by Université Catholique de Louvain  (E/NH)                Phase-I
ATG* autotransplant  Burt                               Phase-I
ATG autotransplant Snarski                             Phase-I




Understanding These Tables


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

Name
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.

Id/Developer
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.

Notes
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.  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.