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Old 04-04-2017, 08:11 PM
Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
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Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
Posts: 832
10 yr Member
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Quote:
Originally Posted by Blackfeather View Post
Am I correct in thinking that this drug, if it pans out, would potentially be effective for most people with PD, since it is designed to remove alpha synuclein from the brain? No matter how one acquired PD, toxic chemical exposure, gut dybiosis, genetic ddefect, head trauma etc., an aggegation of alpha synuclean in the brain results in PD.
If all trial phases are favorable, how long do we have to wait before this drug is available? Thanks
At this time, the working theory for the vaccine/anti-body trials does not account for any differences in the etiology of the disease. That's not to say, though, that there aren't differences. But, it's so hard to get these trials approved and funded as it is, none of the companies involved want to entertain the possibilities, at this time, of sub-categorical differences. It would require huge sample sizes and take too much time.

With regard to timing, unless there are changes in FDA regulations, it's not likely to be anytime soon. This phase 2 won't conclude for 3 1/2 years (Oct 2020) if everything goes perfectly. Then, assume at least another year to get a phase 3 designed, funded and approved. Then another 3 1/2 year to complete that study. Then at least another year for filing and approval of an NDA. So, I would think around 8 more years. Of course, anyone on here who is still early stage (less than 2 years) can try to enroll in the trial and get the infusions immediately, assuming you don't end up in the placebo group. I would definitely consider it if I was eligible.

Let's just hope that it actually has efficacy. Just take a look at the numerous vaccine failures in phase 2 for Alzheimer's (Merck, Biogen and others). Of course, they all worked on Amyloid-Beta while the new target of choice is now Tau.
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"Thanks for this!" says:
jeffreyn (04-04-2017)