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Originally Posted by Blackfeather
This drug looks very promising, but they state that it is 6-8 years before it would be available, if all goes well in trial. I am wondering, if it passes muster in phase 3 trial, whether it might be fast-tracked.... I'll keep my fingers crossed. Maybe there are some natural analogs that work similarly that might reduce alpha synuclein in the brain that may be available now.
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Blackfeather, you may want to check a couple of posts from a few weeks ago when we discussed this study after the news came out. The only location for the new AffiRis study will be in Austria. However, at their webinar/conference two weeks ago (sorry, I don't have the link handy but you'll find it in the thread) they did imply they would consider US locations for the next Phase if the trials move forward. That would probably be sometime the end of next year or early 2016 (a wait, but not nearly 6 - 8 years). So, you can consider joining a future study and hope you get the drug rather than placebo.
Alternatively, you can also consider the currently recruiting study for Prothena (
http://ir.prothena.com/releasedetail...leaseID=863495 ). They are also conducting research on an a-syn antibody. Although it's only a phase 1 study, some researchers I've spoken with are more impressed with their drug and methodology than AffiRis. As the trial has just begun, it will probably go on for at least a year, so you have some time before you would need to join. In addition, even if you were to wait for a possible phase 2, it will certainly be less than 6 years. In most of the trials, your odds of getting the drug as opposed to a placebo will probably be 2 -1 or 3 -1.
I, along with several other members on this board, have had discussions with the trial teams about Prothena's drug PRX002. We will watch it closely, see how the trial proceeds, and make some decisions later.
I suggest considering this approach for two reasons. First, we need volunteers for PD trials worldwide if we ever want to see drugs go through the long research process prior to filing an NDA and receiving approval. Second, if you are going to take a shot at a neuroprotective antibody, I would think you would want to do so with one that has some degree of real science behind it, positive pre-clinical research, and positive phase 1 safety studies. As opposed to a natural analog, if one exists, that no one has the slightest idea about how it would function. These are monoclonal antibodies that may have effects on the body and other proteins that we are not aware of at this time.
Gary