Extension study

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby schnittke » Wed Feb 20, 2008 8:31 am

Hopefully the 6.8 million that was raised equates with things going nicely in regards to the trial. My naivete is beginning to show. Has the end date for the IIb trial been announced?
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Postby Lyon » Wed Feb 20, 2008 9:22 am

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Postby TWG » Wed Feb 20, 2008 10:00 am

Going to the IIb gov web site for the trial we are in It has an end date of September 2008. It has been changed to phase II, not sure why, but it is the study for trial we are currently in.

<shortened url>

The new trial we are starting is:

http://www.clinicaltrials.gov/ct2/show/ ... xin&rank=2

hope this help.
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Postby MaggieMae » Wed Feb 20, 2008 10:36 am

I just read the info for the extension. If the extension trial doesn't end until August of 2009, when will the Phase III trial start? Seems like this is another treatment that is far far away. Makes me sad.
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Postby flipflopper » Wed Feb 20, 2008 10:45 am

The phase II b trial should be completed at the end of August 2008.

Here is a quote from the article below “At the end of August, we completed the initial vaccination of all 150 subjects enrolled in the Tovaxin Phase IIb trial. This is an important milestone because it establishes August 2008 as the date for the last subject to be evaluated for safety and efficacy”


<shortened url>
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Postby schnittke » Wed Feb 20, 2008 11:31 am

So if I extrapolate all the above info it looks as if phase III will not start until 2010 or so :cry: Bummer...
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Postby flipflopper » Wed Feb 20, 2008 11:40 am

If the results of the phase IIb are good, I don’t see why Opexa would wait until the end of the extension study (ending in August 2009) to begin the phase III trial. I think they will start planning and recruiting people for the phase III trial once the results of the phase IIb trial are available (if the results of the trial are good enough).
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Postby Lyon » Wed Feb 20, 2008 1:19 pm

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Postby dignan » Wed Feb 20, 2008 1:21 pm

I agree with flipflopper.
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Postby sh8un » Wed Feb 20, 2008 2:13 pm

can't we just ask the company? I am running to work right now so I can't do it but it might be a good idea.
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