Opexa (OPXA) Surges on FDA Fast-Track Designation.

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby RyanYum » Sun Aug 18, 2013 7:17 pm

so what does this mean, there is no drug out there that's gunna be as effective as they claimed this was supposed to be? Is this the same treatment that is posted here http://www.northwestern.edu/newscenter/ ... m_campaign
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby NHE » Sun Aug 18, 2013 11:38 pm

RyanYum wrote:so what does this mean, there is no drug out there that's gunna be as effective as they claimed this was supposed to be? Is this the same treatment that is posted here http://www.northwestern.edu/newscenter/ ... m_campaign


No, Tcelna and the treatment being developed by Northwestern are two different approaches. The goal with Tcelna is to use it as a T-cell vaccine to try to get the body to get rid of rouge T-cells which are autoreactive against myelin. However, the goal with the Northwestern treatment is to induce immune tolerance of myelin autoantigens by either using dead T-cells loaded with myelin peptides or by using nanoparticles with attached myelin peptides.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby RyanYum » Mon Aug 19, 2013 9:17 pm

thx for clearing that up, how long before you think we see these treatments becoming a reality?
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby NHE » Mon Aug 19, 2013 10:40 pm

RyanYum wrote:thx for clearing that up, how long before you think we see these treatments becoming a reality?


I'm just guessing on these time estimates, so take them with a large chunk of salt...

Since the Northwestern treatment study was phase I it still has to go through phase II and III. This could take 5-6 years or so if all goes well.

Tcelna is in phase IIb for SPMS. Its phase IIb for RRMS failed. We've been discussing Tcelna/Tovaxin for almost 9 years now. Assuming phase IIb with SPMS is successful (a big assumption), then it will still have to go through phase III. That could take a few years.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby RyanYum » Tue Aug 20, 2013 9:13 am

It all seems somewhat ridiculous, wonder if you could get similar treatments by paying more in say germany. The science is out there, so i'd imagine if your wallet was big enough you might be able to get said treatments
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