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Nilotinib R&D results

parkinsons nilotinib

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#1 Logic

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Posted 14 July 2016 - 12:45 AM


This thread is a place for those doing research on the effects of Nilotinib on neurodegenerative diseases or fibrosis to post their results.
 
Please note that while Nilotinib is not a controlled substance under the Controlled Substance Act, it is patented:
 

As such Nilotinib has been provided for research and development use in accordance with (i) 35 USC 271(e)+A13(1) in the U.S.; (ii) Section 69.1 of Japanese Patent Law in Japan; (iii) Section 11, No. 2 of the German Patent Act of 1981 in Germany; (iv) Section 60, Paragraph 5b of the U.K. Patents Act of 1977 in the U.K.; (v) Section 68B of the Patents Act of 1953 in New Zealand; (vi) such related legislation and/or case law as may be or become applicable in the aforementioned countries; and (vii) such similar laws and rules as may apply in various other countries. In the European Union, equivalent exemptions are allowed under the terms of EC Directives 2001/82/EC (as amended by Directive 2004/28/EC) and 2001/83/EC (as amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC).


Please keep any posts professional and impersonal, keeping the above legal status of Nilotinib in mind.
 
I suggest the following template be followed: 

(Copy/Paste the following to your post/PM/Email and fill in the info)
 

Test subject's age:

 

Diagnosed disease being treated:

 

Previous medication and treatments:

 

Concurrent medication and treatments:

 

Date of commencement of Nilotinib:

 

Date of report:

 

Dosage and schedule:

 

Results:

 

Subjective Results:

 

Side effects:

 

Notes:

 
Have I forgotten anything?

Participants who wish to remain anonymous are welcome to contact me via PM or Email and I will post their redacted results here.
Any results LongLife may have collected will also be posted here. (with permission naturally)


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#2 Logic

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Posted 14 July 2016 - 03:57 AM

The Nilotinib Group buy thread:

http://www.longecity...-13#entry782544



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#3 Logic

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Posted 21 July 2016 - 12:01 AM

As posting reports here may influence/placebo others before they post:
DO NOT POST any test results here; PM/Email them to me.  

I am not sure how many reports would constitute a broad enough overview of Nilotinib's effects?

The more results the better, so send them in!

 

mlsirkis made the following suggestion:

 

I have been giving some thought to a monthly status gathering report – since we are doing research.

Perhaps someone familiar with Excel could do a form that could be done on the computer, or printed out then hand completed.
It could be mailed back anonomously to the data collector.

Rows of form are below. Columns are mm/yyyy.

Perhaps it would include:

a. Demographs       

1. ID number of patient

2. Sex of patient

3. Birth year of patient

4. Weight of patient

5. Years with PD.

Symptoms – The first month of reporting enter either a “0” for I don’t have this symptom, or a “10” for I have this symptom. It doesn’t matter how severe. If you have the symptom enter a 10 in the first month of reporting. After that everything is relative for each patient.


1. Tremor

2. Slowed movement

3. Rigid muscles

4. Impaired posture and balance

5. Loss of automatic movements

6. Speech changes

7. Writing changes

8. other – patient fill in

9. other – patient fill in

10. other – patient fill in

The same could be done for side effects.

 

 

My reply:

 

 

Besides identification, I see absolutely no reason why you should not post that in the Results thread Mike.  :)
Lets everyone discuss it!

 

 

Thoughts?

 

Lets do this properly.

:imminst:

 

 

 


Edited by Logic, 21 July 2016 - 12:04 AM.


#4 centralFloridaMan

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Posted 21 July 2016 - 08:19 PM

If some "researchers" have given info on results so far I think that info should be released.  Logic mentioned a concern about a few results might affect other researchers.  From my position no results worry me, if no  results are released i begin to believe that there is a lack of success because if nilotinib was working people would be eager to share or in other words a lack of news  might affect people with a reverse placebo effect.


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#5 niner

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Posted 22 July 2016 - 09:49 PM

If some "researchers" have given info on results so far I think that info should be released.  Logic mentioned a concern about a few results might affect other researchers.  From my position no results worry me, if no  results are released i begin to believe that there is a lack of success because if nilotinib was working people would be eager to share or in other words a lack of news  might affect people with a reverse placebo effect.

 

I dunno, centralFL.  I think Logic is taking the right path here.  If he's getting results, he could tell people that he's seeing results without saying what they are.  I think that a normal placebo effect is a lot more likely than a hypothetical reverse placebo effect.  In a real clinical trial, patients would NEVER see other people's data before the end of the trial.


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#6 Logic

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Posted 22 July 2016 - 10:03 PM

Thank You for your input Niner.

(We seem to have been posting at the same time)
Personally I miss the input from you; our former moderator and mentor.

 

One person who wishes to remain anonymous has sent me their research results and I have the results of research.

That makes only 2 data points, including mine, so far.  Not enough to form any kind of conclusion IMHO.

I will post them when I am done sending out the round 3 costings as that seems to be what most people want...??

 

There are also a number of participants that have chosen to remain anonymous or have not posted past the bare minimum required to acquire N.  I will contact everyone and ask for feedback.

Has anyone heard from Longlife?  I was hoping for his assistance here as this is going way beyond merely organising a group buy...

If anyone sent him results please post here or forward them to me too plz.

 

I know that many participants bought N as a prophylactic or as insurance against any possible dementias in their futures, so one can not expect results from everyone.

For others; legal concerns may be holding them back.  I would like to point out that the proper gathering and presenting of information here, anonymous or otherwise, should allay such concerns...


Edited by Logic, 22 July 2016 - 10:08 PM.


#7 centralFloridaMan

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Posted 23 July 2016 - 12:15 AM

Niner,  Unfortunately this is not a double blind clinical trial.  As a someone with a significant investment in nilotinib I might seriously reconsider  what to do from here if there is nothing encouraging happening with group buy #1.  If I embark on being a researcher my subject  would require careful monitoring by a neurologist and may have to give up a chance to participate in clinical trials.  My subject may also decide to hedge his bets by selling sime of his N.  Unfortunately there are more issues with this research than in a more rigorous type of clinical trial.  While apparently there is only one report other than logic so the issue is moot, it is more complex than your  response would indicate, in my opinion.  What I would say with emphasis is that many people are hopefully waiting for some indication if they should proceed so whether what the group 1 participants are seeing no change or positive effects please submit your results(names or screen names don't matter) to logic.    centralflman



#8 roydeman

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Posted 23 July 2016 - 04:56 PM

I am waiting until I read other responses. I do not currently have PD, just strong indications that I'm heading that way. I will be getting an EKG first, as I am type 1 diabetic which prolongs the qt interval to begin with. It's hard for me to justify taking a cancer drug if it's not neuroprotective, as I don't need symptomatic relief.

#9 richard hnry

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Posted 29 July 2016 - 12:44 AM

It would be nice if someone would post some results so we can see how N worked for the researcher's balance , walking , and energy. These are the most critical .



#10 Logic

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Posted 29 July 2016 - 05:28 PM

I still only have the 2 research results, of which one is on MSA for 1 month at 150 mg per day.

 

I am up to my ears in work and group buys for Tiron and Dasatinib so if anyone would like to volunteer to contact the researchers from round 1 and collate the data; I can supply a list of usernames, unless anyone, of them, objects..? 

(Those who have asked to remain anonymous excepted. I will contact them myself)



#11 roydeman

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Posted 31 July 2016 - 06:12 PM

If you have no takers I will reach out and at least compile the info I receive back
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#12 Logic

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Posted 01 August 2016 - 08:47 PM

If you have no takers I will reach out and at least compile the info I receive back

 

Thx for the kind offer Roydeman.

I got a quick Email from LongLife saying he had been away from internet connectivity due the bad weather where he resides.

He says he has a month's worth of Emails etc to go through and will get back to me, so lets wait till he replies and take it from there?

 

I have also received a number of communiques from researchers worried about legal repercussions and unwilling to even acknowledge receipt of N...

There is some discussion on this matter and I/we will privately communicate some ideas to everyone soon.



#13 richard hnry

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Posted 02 August 2016 - 03:28 AM

I would like to see some preliminary results too.



#14 Linda Gray

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Posted 21 August 2016 - 08:23 PM

I would gladly compile the results and would definitely keep the researcher anonymous.
I'm very interested in knowing of any improvements and/or problems. Also any tips on when and how to take it.

#15 David Watford

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Posted 10 November 2016 - 11:16 PM

Comment by Neurologist.. who disapproves of my doing this.

Dosage spreadsheet attached

 

David was followed up today. It is been about two months since we last saw him and in the interim he has started on the self treatment.   

He is making the tablets at home and initially started on 150 mg once a day but ran into some  problems with gastric symptoms and so came off it for a period of time and then restarted at 50 mg once a day

He took an ECG when he had the abdominal and chest discomfort and comment is made that his  ECG was normal.

Interestingly David has come in today saying that he feels much brighter. He feels his sense of smell has improved, he is signing of signature more easily and is drooling less

He also says he has more energy. He continues to take the Madopar two tablets in the morning, one at midday and one in the evening.

He denies any other ill effects from the medication and overall is feeling much brighter

We completed the motor component of the UK PDRS and interestingly his score has improved from 42 down to 35.

The improvement is mostly with rapid alternating movements.  I think it's a little too early to be confident that the treatment itself is responsible for this given the fluctuations that it can occur with Parkinson's disease.  However, it is reassuring result and we will review David again in three months’ time.

 I note that he has had a number of blood tests and his full blood count has remained stable.

 

I agree that this could be a fluctuation

D

Attached Files


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#16 Linda Gray

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Posted 10 November 2016 - 11:33 PM

I would love to help correlating information and have no problem keeping the information confidential.  I am particularly interested in researcher working with MSA and N.

 

Thanks,

Lina



#17 Logic

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Posted 14 November 2016 - 03:11 PM

I have gone through the entire group buy thread and copy pasted all the informal reports I found into a Google Document.
I did the same (Personal info redacted) with the PMs I have received.
I have not yet completed going through the 105 Nilotinib related Emails I have received.  (The process keeps being interrupted by trips to Mozambique and related work, forcing me to start over)

It would be great if perhaps LInda Grey, or another volunteer could be 'elected' to go through this info and turn the very informal information into something more formal, while I finish up with the Emailed information?

 

 

Rawin sent me the results of a survey done on N for PD by the Michael J Fox foundation.

https://www.michaelj...ilotinib_update
I have not yet been able to find the PDF on their site, so here it is:
https://drive.google...iew?usp=sharing

 

 



#18 Linda Gray

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Posted 14 November 2016 - 03:16 PM

Logic, I would love to
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#19 Logic

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Posted 21 November 2016 - 07:43 AM

Logic, I would love to

 

I will PM you shortly Linda.
I end up doing battle with this slow old notebook every time I try and do anything as demanding as collate all the data, but am getting there slowly.



#20 Logic

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Posted 21 November 2016 - 01:28 PM

mlsirkis is a keen PD researcher and has sent me many links to Nilotinib research results as well as research into other substances.

He is in fact the 1st person who sent me the link to:

 

The M. J. Fox Nilotinib for PD survey that one can take part in:
https://www.surveymo....uk/r/nilotinib

 

Provisional Results:

https://drive.google...iew?usp=sharing

 

A clinical trial:

Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease (PD Nilotinib)

https://clinicaltria...2954978#wrapper

 

 



#21 Linda Gray

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Posted 28 November 2016 - 03:10 PM

Logic, I would love to


I will PM you shortly Linda.
I end up doing battle with this slow old notebook every time I try and do anything as demanding as collate all the data, but am getting there slowly.


#22 Linda Gray

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Posted 28 November 2016 - 03:13 PM

Logic, you can send me the responses you have and I will compile them. Please PM me.

#23 MarcB

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Posted 29 December 2016 - 03:06 PM

N progress report.  In brief, nothing yet.

 

I am a 70 y.o. male, 6’2”, & 190 lbs, handsome, and charming.  The VA agrees I likely got PD from Agent Orange while in Vietnam in 1967 (maybe that’s relevant?)  I was diagnosed in July, 2011, but noticed early signs of tremor in spring of ’08.  I believe PD has been progressing more slowly in me.  I take no PD drugs.  I took Sinemet for about 6 months about 2 years ago.  I take 300 mg/day of Bupropion, 50 mg/day of Larsatan, 2.5 g/day Melatonin, and 1,000 mg/day NAC. 

 

My primary issues are tremor in both arms, slow movement, and diminished coordination, especially in my left hand.  Constipation was a problem until I began walking every day a year ago which almost eliminates it.  If I go a week without walking, it returns.  I walk 3 – 4 miles/day, 5 days/week and spend 45 mins in the gym 2/week.  (I am resolved to substantially increasing my exercise.) My mental state and memory are unchanged.

 

Dose; Beginning 10/23/2016, first thing in the morning, I began with 75 mg/day for 3 days, then 100 mg/day for 12 days, then 110 mg/day for 2 weeks, then 125 mg/day for 2 weeks, then I added grapefruit juice.  Today, 12/29/2016, I moved up to 140 mg/day, with grapefruit juice.  I also have coffee and oatmeal.

 

Question; I understand grapefruit juice increases the bioavailability by 60% (https://www.ncbi.nlm...pubmed/19948946) and therefore, many who post here feel it should not be taken with juice or food, but isn’t that important only if your dose is at the upper end of the safe level 600 – 800 mg/day?  If my dose is 125 mg, doesn’t the grapefruit juice make that the equivalent of approximately 200 mg?

 

Results; No side effects and probably no benefit, although I do feel I have not progressed/gotten any worse the past 4 – 6 weeks.

 

My theory; that N hasn’t done anything for me yet is because I’m still at too low a dose.  Unless Moussa et. al at Georgetown are grossly misrepresenting the truth, which is highly unlikely since Michael J Fox & Co (and others) are investing millions in separate trials, I remain confident N will make a significant difference in my life.  (Keeping in mind that to launch such trials involves the review and approval of many government, foundation, and drug company panels of scientists, doctors, and investors.  I figure they would not spend this kind of money unless there is something there.)

 

I’m going to stay at 140 – 150 mg/day with grapefruit juice (coffee & oatmeal) for 3 months before I bring in the jury.  I’ll report back then or sooner if I get results sooner.

 

On another matter, check out this link.

 

https://www.ncbi.nlm...les/PMC2367001/

 

“In this uncontrolled study, Parkinson’s disease patients experienced a mean of 43% reduction in Unified Parkinson’s Disease Rating Scale scores after a 28-day exposure to the ketogenic diet.”


Edited by MarcB, 29 December 2016 - 03:09 PM.


#24 Jaris

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Posted 19 March 2017 - 06:10 PM

I have PD and I've been watching this thread, hoping to get any indication that some researcher is seeing some benefit.

But there have been very, very few posts. Someone (Linda) was going to compile emails?

So far, David's possibly  seeing some positive results, but MarcB has seen none. Surely there's been more feedback than this?

Please, I'm trying to decide if I should start my own research or keep doing what I'm doing.

Thanks!



#25 togl

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Posted 23 March 2017 - 05:30 AM

HI,

 

should we post results here or send to someone for collation (Logic/Linda/??)? What is the current protocol? Thanks!



#26 Logic

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Posted 23 March 2017 - 10:29 AM

HI,

 

should we post results here or send to someone for collation (Logic/Linda/??)? What is the current protocol? Thanks!

 

I think anyone comfortable with doing so can post here directly.
Those who wish to remain anonymous can send their results to me.  I will redact personal information and assign a reference #, but otherwise post them as is.
I also recommend  The M. J. Fox Nilotinib for PD survey:

https://www.surveymo....uk/r/nilotinib

But plz do also post here or contact me as there seem to be some questions as to the legitimacy of the N acquired through me in some new forum members' minds.


Edited by Logic, 23 March 2017 - 10:36 AM.


#27 vijaiprao

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Posted 17 September 2017 - 07:11 AM

Hi,

Does anyone have new info to share? also, can you kindly share the anonymous results with me as a private message?

Thank you
VJ

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#28 rikelme

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Posted 06 February 2020 - 06:17 AM

Nilotinib appears safe in Parkinson's trial; drug thought to allow dopamine replenishment

 

...participants taking nilotinib had reduced levels of alpha-synuclein (20%) and tau (30%), two toxic proteins characteristic of those with Parkinson's disease.

 

 

That's after 150mg or 300mg daily, for 12 months. Looks promising. Full text:

 

Nilotinib appears safe in Parkinson's trial; drug thought to allow dopamine replenishment
8-10 minutes

WASHINGTON - A clinical trial investigating the repurposed cancer drug nilotinib in people with Parkinson's disease finds that it is reasonably safe and well tolerated. Researchers also report finding an increase in dopamine, the chemical lost as a result of neuronal destruction, and a decrease in neurotoxic proteins in the brain among study participants. Finally, they say nilotinib, a tyrosine kinase inhibitor, potentially halts motor and non-motor decline.

 

The results of the small, phase II trial conducted at Georgetown University Medical Center (GUMC) are published Dec. 16 in JAMA Neurology.

"Determining the safety of nilotinib in people with Parkinson's was our primary objective," explains Georgetown neurology associate professor Charbel Moussa, MBBS, PhD, the senior author of the study, and director of the GUMC Translational Neurotherapeutics Program.

Seventy-five participants (average age 68.4) with moderately advanced (stage 2.5-3) Parkinson's disease and stable symptoms participated in the trial. They were randomized to receive either placebo, 150mg or 300 mg of nilotinib. Twenty-five participants were in each group.

To prevent bias in reporting, the study was blinded, meaning neither the study participants nor the study investigators knew if the active drug or placebo were being administered until the end of the individual's study period. Participants took the placebo/nilotinib by mouth for 12 months, followed by a 3-month period of taking no placebo/nilotinib (washout).

 

Eighty-eight percent (88%) of the participants completed the study; two participants withdrew from the placebo group, three withdrew from the 150mg group (one voluntarily, two for non-compliance), and four in the 300mg group withdrew (one voluntary, one due to non-compliance and two for significant adverse events).

 

Nilotinib (Tasigna® by Novartis) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic myeloid leukemia. It carries an FDA "black-box warning" because of sudden death due to the inhibition of Abl tyrosine kinase, an important protein for cellular function. Nilotinib is administered in higher doses (300mg twice a day) for cancer treatment than were studied in this trial (150mg and 300 mgs once a day).

 

"Our study shows that at these lower doses, nilotinib does not seem to cause Abl inhibition, suggesting it shouldn't have the same safety concerns that are potentially associated with Abl inhibition as might be the case at higher doses," Moussa says. He adds that no one withdrew from the study due to tolerability.

 

In a secondary finding of exploratory biomarkers, participants taking nilotinib had reduced levels of alpha-synuclein (20%) and tau (30%), two toxic proteins characteristic of those with Parkinson's disease.

 

"Individually, these are very important findings, but taken together, it means that the clearance of these neurotoxic proteins may not solely depend on Abl inhibition -- other tyrosine kinases or alternate mechanisms may be involved," explains Moussa.

 

In addition, those taking nilotinib had a significantly increased level of dopamine metabolites (>50%) suggesting that the clearance of the toxic proteins allowed for an increased utilization of the brain's own dopamine.

 

As part of the study, clinical outcomes were assessed at six, 12 and 15 months and compared to assessments at the start of the trial (baseline). Clinical testing was conducted at the optimal time of day for each participant based on the individual's standard of care treatment (typically levodopa or a similar drug).

 

In exploratory clinical findings, non-motor, quality-of-life self-reports (PDQ-39) appeared to worsen in the placebo group, but nilotinib appeared to mitigate this progression for at least 12 months.

 

In another clinical observation, all study groups seem to improve on motor testing (UPDRS-III) at six months, however, those on placebo and 300mg remained stable at 12 and 15 months, while the 150mg group improved between baseline and 15 months.

 

"We see that subjects on nilotinib performed better overall on motor testing and had a better quality-of-life measurement during the study than the placebo group. These are important observations suggesting that nilotinib stabilized the disease--a potential disease modifying effect that we haven't observed with any other agents," says Georgetown neurology professor Fernando Pagan, MD, medical director of the GUMC Translational Neurotherapeutics Program and principal investigator on this study.

 

"These clinical findings need confirmation through larger studies with more diverse populations," adds Pagan, who also directs the Movement Disorders Clinic at MedStar Georgetown University Hospital.

 

The investigators wish to thank all study participants and their families who participated in this trial over two years and hundreds of clinic visits.

 

In addition to Pagan and Moussa, authors include Michaeline L, Hebron, MS; Barbara Wilmarth, RN; Wangke Shi, MS; Sanjana Mulki, MS; Tarick Kurd-Misto; Sara Matar, MS; Xiaoguang Liu, MD, PhD, and Jaeil Ahn, PhD, all of GUMC;; Yasar Torres-Yaghi, MD; Abigail Lawler, MD; Elizabeth E Mundel, MD; Nadia Yusuf, MD; Nathan J Starr, MD; Muhammad Anjum, MD; of GUMC and MedStar Georgetown University Hospital; and Joy Arellano, RN; Helen H Howard, RN; of MedStar Georgetown University Hospital.

Georgetown holds an issued US patent for the use of nilotinib for the treatment of certain neurodegenerative diseases and has other pending patent applications in US and foreign jurisdictions. Moussa is the named inventor on the intellectual property.

Pagan reports that he is a consultant/speaker for Accorda Therapeutics, AbbVie, Acadia Pharmaceuticals, Adamas Parmaceuticals, Merz Pharma, Teva Pharmaceutical Industries, Sunovion, and US WorldMeds. He has educational or research grants from Medtronic, Teva, US WorldMeds and research grants from Alzheimer's Drug Discovery Foundation and Sun Pharmaceuticals.

 

This study was supported by the Lasky-Barajas Family Fund and additional donors. Novartis, the maker of nilotinib, provided nilotinib and matching placebo free of cost to Georgetown University for all participants while on the study and was not further involved in this exploratory study. The research was supported by Georgetown's Clinical Research Unit, which is funded by a Clinical and Translational Sciences Award (CTSA) from the National Institutes of Health (UL1-TR001409).

 

Laboratory analysis from the first arm of the phase II clinical trial, published March 12, 2019 in the journal Pharmacology Research & Perspectives, showed that a single low dose of nilotinib reduces levels of a toxic protein that prevents the brain from utilizing dopamine that is stored in tiny vesicles, or pockets, in brain areas that may control movement.

 

This clinical trial followed a proof of concept study conducted at Georgetown, published July 11, 2016 in the Journal of Parkinson's Disease, providing molecular evidence that nilotinib significantly increased brain dopamine and reduced toxic proteins linked to disease progression in Parkinson's disease or dementia with Lewy bodies.

 

###

Georgetown researchers published seminal findings of nilotinib effects in Parkinson's disease models in 2013 in Human Molecular Genetics and showed that low doses of nilotinib increase brain dopamine levels, reduce alpha-synuclein and improve motor functions in Parkinson's disease mouse models.

 

About Georgetown University Medical Center

Georgetown University Medical Center (GUMC) is an internationally recognized academic health and science center with a four-part mission of research, teaching, service and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter).

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.



 

 


 

Edited by rikelme, 06 February 2020 - 06:21 AM.






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