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04-04-2017, 11:09 AM | #1 | ||
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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 |
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04-04-2017, 08:11 PM | #2 | ||
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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) |
04-04-2017, 08:13 PM | #3 | ||
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For those who may be interested in enrolling, the trial will begin recruitment in June. You can see the inclusion criteria and locations here:
A Study to Evaluate the Efficacy of RO7 46 15 in Participants With Early Parkinson's Disease - Full Text View - ClinicalTrials.gov |
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"Thanks for this!" says: | jeffreyn (04-04-2017) |
04-04-2017, 09:13 PM | #4 | ||
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Blackfeather said: ".... an aggegation of alpha synuclean in the brain results in PD."
It is my understanding that this has not (yet) been proven, although it is fairly safe to say that an aggregation of alpha synuclein in the brain is associated with PD. As Tupelo3 said: "Let's just hope that it actually has efficacy." IMHO, they might end up (eventually) finding that PD results in an aggregation of alpha synuclein in the brain, rather then an aggregation of alpha synuclein in the brain results in PD. |
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"Thanks for this!" says: | Tupelo3 (04-04-2017) |
04-04-2017, 10:18 PM | #5 | ||
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As I said, all of the Alzheimer's research has failed to date. Could be that the drugs just don't work in the cell like they do in cerebral fluid ; could be it attacks the wrong protein ; or it could be that the protein aggregation is just a by-product of the disease and not part of the causal sequence. |
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"Thanks for this!" says: | jeffreyn (04-04-2017) |
06-22-2018, 09:47 PM | #6 | ||
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This recent article from AlzForum gives an update on PRX002 (plus discussion and comments).
α-Synuclein Antibody Appears Safe, Reaches Brain | ALZFORUM |
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06-23-2018, 09:58 PM | #7 | ||
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This post on the SoPD blog covers the recently-released PRX002 Phase 1b results (and includes a lot of background information).
Prothena: Phase I results published | The Science of Parkinson's |
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"Thanks for this!" says: | kiwi33 (06-24-2018) |
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