Frustrated on priority with Tasigna/nilotinib
 

Has anyone else noticed how slow the Tagisna trial process for PD is moving but how fast it is moving for Alz? This is so frustrating! Moussa's work at Georgetown was done on PD, he's talked about a bigger trial for PD, Fox has talked about a Tagisna trial for PD, as have others...but these trials have gotten pushed back for over a year. Even now I cannot find where the trial sites will be, when recruitment will begin, what the criteria will be, nothing.

Meanwhile, the FDA has apparently approved a clinical trial of Tasigna for Alz. and the trial is schedule to begin THIS YEAR:

Alzheimer's Study Funded by ADDF to Test Cancer Treatment in Patients

What's up with this?

Yes, it is very frustrating. If you read my previous posts about this you'll get the story. Basically, GU was able to secure funding from an AZ foundation while they were having difficulty funding a new PD trial. They still say that they intend to conduct a PD study, however, I don't know that they have the funds yet. Regarding the MJFF et al trials, that was never supposed to happen until later in 2017. It is way to early to be looking for trial sites as they are still designing the trial. There is no information yet on inclusion/exclusion criteria. If GU finds the money, that trial will likely commence earlier than MJFF.

There is also a third trial that you may want to follow. A small biotech company, Inhibikase Therapeutics, has received FDA approval to begin a double-blinded, placebo-controlled trials for Nilotinib and Dasatinib (Sprycel - Bristol-Myers). The trials will try to evaluate the ability of both drugs (vs placebo) to slow or reverse progression in Stage 2 and 3 PD patients. It will be held at one test site over a 6 month period.

The reason Inhibikase is conducting the studies is really more of a proof of concept for two new drugs that they are researching. They are developing two Abelson tyrosine inhibitors that are as much as 60 times more potent than the ones currently on the market (Nilotinib, Dasatinib, Gleevec, etc.).

Thanks:)
 

I guess that's my point: all these PD orgs out there, many of them huge, and not one of them could fund a trial for Tasigna? They couldn't team up if they didn't want to put all of those research dollars in one basket?

The trials have already been pushed back once that I read about, who knows what really happens behind closed research doors.

I have read politics/power were involved between the Fox/GMU that caused that split, and thus we lost valuable time with them doing a PD trial, which is even more frustrating.

We are following the Gleevec/Tasigna second generation drugs, thanks!

[QUOTE=lurkingforacure;1227497]I guess that's my point: all these PD orgs out there, many of them huge, and not one of them could fund a trial for Tasigna? They couldn't team up if they didn't want to put all of those research dollars in one basket?

QUOTE]

Feel the same as you, couldn't agree more.........

Another company that you may want to follow is Proclara biosciences. They claim to have a single drug that eliminates misfolded protein in multiple Neuro illnesses. They are currently in phase 1a clinical trial. They used to be known as macrophage.

Proclara Biosciences

Yes, Proclara is definitly a company to watch. Their technology is world class. Actually, their original name was NeuroPhage. They along with AffiRis and Prothena are the three most advanced immunotherapy therapy companies with vaccine in active trials.

USA based:
https://clinicaltrials.gov/ct2/resul...&Search=Search

Parkinson's Disease | Therapies in Development for Parkinson's Disease

FOX TRIAL FINDER : Parkinson's Disease Clinical Trials

Hi lurking,
this is an interesting article about that:
α-Synuclein binds to TOM2 and inhibits mitochondrial protein import in Parkinson’s disease | Science Translational Medicine

If Tasigna gets approved for Alzheimer's as both safe and effective, if preliminary trials show success with Parkinson's, could it then be prescribed as an off-label drug for Parkinson's?

Actually, it can be prescribed right now off-label. The FDA only controls drug approval, not drug prescribing. Doctors are free to prescribe any drug for any reason they believe is medically appropriate (in the USA, not sure about other countries). Of course, it does open the doctor to more liability risk. Also, insurance companies are unlikely to cover the cost of the prescription.

If you don't want to wait for the end of the phase 2 trials, or can't find a doctor to prescribe off label, or can't afford this expensive drug, yet still want to take it, then consider volunteering for the multi- center study next year. If you qualify, you can get the drug for free and properly monitored (assuming you don't get the placebo.....). You'll also be helping the whole PD community by moving the science forward.

I'm having trouble getting my arms around this, I really am. First of all,
no one on the planet has any more respect for MJFF than I do, or least
I used to have. And I'm sure everything I've read about this pi**ing
match between GU and MJFF isn't guaranteed to be 100% accurate, and
yes I'm very much aware that there are some incredibly talented people
at MJFF, BUT I feel a slow rage that I'm not sure that I've experienced
ever in my life. and of course, that is the last thing that anyone needs
with tremor (yes, some level of tremor even after DBS).

To MJFF and the like, DO NOT take the American populace and various
philanthropy organizations for granted. And I don't want to see headlines
on your web sites bragging about all your wonderful research that may or
may not position us to apply for a trial in 5 years as I struggle to shave,
shower, urinate, dress, speak, and pray that my spouse doesn't give up
on me.

I've had enough. Either reposition your business model to do a much,
much better job at producing tangible results next year (meaning
products with actual benefit IN the pipeline), exhausting ALL resources
in this incredible country, or do us all a favor and join the hot dog
vendors in front of your posh offices and be content to make less than
10K a year.

First-in-human assessment of PRX002, an anti-α-synuclein
 

Just found this on Veritas. Know nothing about PRX002.

First-in-human assessment of PRX2, an anti-α-synuclein monoclonal antibody, in healthy volunteers. - PubMed - NCBI

First-in-human assessment of PRX002, an anti-α-synuclein
 

Just found this on ******* (correction). Know nothing about PRX002.

First-in-human assessment of PRX2, an anti-α-synuclein monoclonal antibody, in healthy volunteers. - PubMed - NCBI

*******
 

Sorry, it's *******

http://www.************/parkinsons.disease/

Ashleyk, we've had multiple conversations about PRX002 on this board. It's the vaccine that Prothena is working on. If you a run a search for "prothena", you will find many posts with a lot of information.

Not sure if this was posted before, but this was a good story about how the MJFF mishandled this with GU:

Parkinson's disease study caught in feud involving Fox Foundation

And a response from the MJFF CEO on this matter:

Fox Foundation committed to moving rapidly and carefully on Parkinson’s drug trial - The Boston Globe

You can't always believe what you read in the press. Rarely do they get the full story accurately. In any case, that's all history which can't be changed. I think whats really important now is that all three Nilotinib trials (GU. MJFF et al, and Inhibikase) are scheduled to begin in 2017. Given the total sample size will be quite large when looking across all three studies, we should get a good feel for how effective the drug is (or isn't) in improving symptoms and slowing progression.