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Tolerx's Otelixizumab Fails in Phase-III Trial

Otelixizumab (Tolerx / GlaxoSmithKline) Fails Phase-III Trial

The official quote is "did not meet the primary efficacy endpoint".  Basically, the the people who got the drug did not do better than those who did not, in the the most important  measurement of success.  The primary endpoint for this experiment was C-peptide generation, which is a marker for natural insulin production.  Basically, they were hoping that giving this drug would help honeymoon type-1 diabetics generate more of their own insulin, but it did not.

In terms of actions: they have stopped enrollment in their second phase-III trial (DEFEND-2), which shows that they think that there is little to no hope of moving forward with this drug at this time.

So that is about as dead as a phase-III trial can get.  

Press release: http://classic.cnbc.com/id/42028160
Tolerx blog: http://tolerx.com/index.php?page=greenchair&entry=committed-to-the-promise-of-our-normalization-immunotherapy-platform
DEFEND-1: http://www.clinicaltrials.gov/ct2/show/NCT00678886
DEFEND-2: http://www.clinicaltrials.gov/ct2/show/NCT01123083

A Little Discussion

This is not completely unexpected, because there was another similar drug (Teplizumab), which was also an anti-CD3 monoclonal antibody which was also in phase-III clinical trials and just a few months ago, it failed as well.   And for the same reason: did not cure/improve people.  Neither trial had any safety problems.

There is still one anti-CD3 monoclonal antibody out there.  It is NI-0401 by NovImmune, and is in phase-II clinical trials.  Unfortunately, I've never been able to find results for their phase-I study, so I don't hold out much hope.  If you know anything about NovImmune's NI-0401 results, or where they were published, then please tell me.

Previous blogging on Teplizumab:
http://cureresearch4type1diabetes.blogspot.com/search/label/Teplizumab
Previous blogging on NI-0401:
http://cureresearch4type1diabetes.blogspot.com/search/label/NI-0401

So where are we now?

Years ago, there was only one treatment in phase-III trials: DiaPep277.  Last year, there were four.  Since then, two have failed and none have entered, so we are down to two: GAD65 and DiaPep277.  GAD65 is expected to announce their first phase-III results in the next 3 months, but DiaPep277 results are much farther away.

The official musical accompaniment for this blog entry is "River of No Return" from The Jeff Healey Band's album "See the Light".  
      It's a cold hard lesson, that you're gonna learn, on the river of no return....

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.
Blog: http://cureresearch4type1diabetes.blogspot.com To Get as Email Join here: http://groups.google.com/group/type-1-diabetes-clinical-trials-news
Web: http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials

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