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New ALS Drug that regulates macrophages
 Moderated by: Dr Trevor Marshall  

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ChrisMavo
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 Posted: Wed Nov 16th, 2011 07:28

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There is a new drug for ALS currently being trialed by the FDA.  Right now it is called NP001 and was developed by Neuraltus.  There have been some reports of this new drug having some success in at least slowing down ALS.  Here is the description of this new drug from their website:
 
About NP001 NP001, a novel, proprietary approach that regulates macrophage activation, targets diseases including ALS, Parkinson’s disease, Alzheimer’s disease and multiple sclerosis. NP001 is designed to transform select immune cells (macrophages) from a neurotoxic state to a neuroprotective state, normalizing the cellular environment of critical nerve cells. Neuraltus’ focus on macrophages is based on the recent understanding of the fundamental role of inflammation and macrophages in neurological diseases. Runaway inflammation has been associated with many of the symptoms seen in severe neurological diseases and is believed to play a major role in the progression of these diseases. Treating inflammation of the central nervous system (neuroinflammation) provides a robust platform for addressing upstream disease mechanisms associated with the most severe neurodegenerative diseases
I was asked to take part in this trial, but turned it down due to my belief in the science behind the MP.  What I find interesting though is this new drug's action of modulating the action of macrophages.  As we know, the MP is good at cleaning up the innate immune system and hence it then triggers recovery in the long run. 

This new drug appears to do what most drugs do now days... treat the symptoms ... while being immunosuppressive.  I see two possibilities here.  1) that the macrophages are infected and go haywire attacking healthy neurons in the CNS or 2) that the macrophages are just doing their job in going after infected neurons.  These infected neurons could be infected with CWD bacteria or any mixture of microbiota. 

So even though I continue to decline after over two years on the MP, I am totally committed to finding out whether the MP will or will not be able to defeat this devastating neurological disease called ALS!






____________________
PLS/ALS, speech difficulty, dizziness, leg weakness, overly emotional, Ph1Aug2609,11/2012 25D-12, 11/11: 25D-10, 04/11: 25D-11, 07/10: 25D-13, 05/10: 25D-15, 11/09: 25D-20, 9/09: 25D-27, 7/09: 25D-38, 1,25D-46, Mod Ph2Oct09, 100mg Mino
Lottis
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 Posted: Wed Nov 16th, 2011 08:45

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Thank you Chris! You have the heart of a soldier in your determination. It is good for me to hear and my heart goes out to you.:)



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HTN,LVH,CHF,arrhythmia,variant angina,IBS?,fibromyalgia?salivarystones,gallstones,CPAP,|15feb-07 init. 1,25D 37,5,|25-D 7,8(15/2-07)| Ph1 30/5-08|Olmesartan alone|NoIR's|covered up|disabled|
Dr Trevor Marshall
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 Posted: Wed Nov 16th, 2011 08:47

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Chris,
I am sure that if the new drug works really well, and the description is clear that it suppresses inflammation, we will find out quickly enough, and you will get the chance to take advantage of it :)

But as you say, there have been lots of attempts at immunosupression in the past, and one has yet to make its mark upon ALS...

..Trevor..
ps: Titta and I am in Singapore, preparing for the ACA conference starting tomorrow. I will be back home, starting to move our own drug 'through the FDA' next week : :)
 

ChrisMavo
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 Posted: Wed Nov 16th, 2011 09:21

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Thank you Lottis ... I appreciate your kind words and encouragement!

I hope both Titta and you have an excellent conference Dr Marshall.  I look forward to seeing the videos of your presentations when you return. 

And of course I can hardly wait to get into the pure olmesartan study ASAP!  :D



____________________
PLS/ALS, speech difficulty, dizziness, leg weakness, overly emotional, Ph1Aug2609,11/2012 25D-12, 11/11: 25D-10, 04/11: 25D-11, 07/10: 25D-13, 05/10: 25D-15, 11/09: 25D-20, 9/09: 25D-27, 7/09: 25D-38, 1,25D-46, Mod Ph2Oct09, 100mg Mino
EpoxyJan
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 Posted: Mon Nov 21st, 2011 21:09

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ChrisMavo wrote: There is a new drug for ALS currently being trialed by the FDA.   
....targets diseases including ALS, Parkinson’s disease, Alzheimer’s disease and multiple sclerosis. .......is based on the recent understanding of the fundamental role of inflammation and macrophages in neurological diseases. Runaway inflammation has been associated with many of the symptoms seen in severe neurological diseases and is believed to play a major role in the progression of these diseases.  
 
... treat the symptoms ... while being immunosuppressive.  

Hi Chris,

Do I understand it correctly that these neurological diseases are associated with the immune system? For me this alone would already be good news. (Until now I always heard that the cause of e.g. Parkinson's is unknown.) From our perspective a support for the MP I guess.

Like Annemarie waiting for your next progresss report, all the best,

Jan



____________________
Parkinson's end2006, 1-25D65,25D16(Aug08), MPstart22Sept2008, 25Dvalues:7(Nov08)4.8(Feb09)10(July09)9.6(Jun10)6.4(Sep11)7.2(July13)13.6(Jun14),
Park.meds started Nov09(L-dopa/Carbidopa), no Olmesartan break.
ChrisMavo
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 Posted: Mon Nov 21st, 2011 22:26

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I too found it interesting that a drug targeting the immune system was being tested on ALS.  And from what I have heard it appears to have had some success in at least slowing the progression of ALS.  So I too feel this is good news for the long-term benefits of the MP for ALS ... since it strengthens the immune system and does not simply suppress the immune system! 

As for my progress, I am having a really rough time lately and will try to post a status report soon.  Thanks for your caring! :D



____________________
PLS/ALS, speech difficulty, dizziness, leg weakness, overly emotional, Ph1Aug2609,11/2012 25D-12, 11/11: 25D-10, 04/11: 25D-11, 07/10: 25D-13, 05/10: 25D-15, 11/09: 25D-20, 9/09: 25D-27, 7/09: 25D-38, 1,25D-46, Mod Ph2Oct09, 100mg Mino
Dr Trevor Marshall
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 Posted: Tue Nov 22nd, 2011 06:19

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since it strengthens the immune system and does not simply suppress the immune system
This cannot be true. Any drug which strengthens the immune system will generate IP,and a lot of it. There is no way that a drug could come to market if it strengthens the immune system. All drugs must palliate, or they will fail today's clinical trials.

You see, if any markers go out of range, due to IP, a conventionally designed clinical trial will be terminated. I have some ideas on how we might solve this as we go forward -- but at this point in time what we have achieved with your help here on the Internet cannot be replicated in "evidence based" clinical trials. Most, probably all, Institutional Review Boards will regard any IP as an 'unnecessary' risk to the patient.

So, if a drug is being investigated in a University setting, you must assume it is palliative, most probably immunosuppressive, it does not "strengthen the immune system."

I know it is tough to believe that medicine has gone down this path, but every conference I attend emphasizes more and more that what we have all achieved here is unique. Clinical Medicine's lack of understanding about the immune system is staggering, almost overwhelming.

When my video from Singapore is online you will be able to see this even more clearly :)

...trevor...
 

Dr Trevor Marshall
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 Posted: Tue Nov 22nd, 2011 06:44

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Let me give a specific example.

In Singapore there was a presentation on a new drug which is supposed to kill off B-Cells which have not gone clonal, thus stopping the generation of new auto-antibodies. In the clinical trials, it didn't stop the disease symptoms significantly better than placebo.

I asked why we are continuing to accept that auto-antibodies are the drivers of disease, when we can totally knock out B-cells with Rituximab without curing the disease process. The graph below was taken from the recent CFS study, and shows total knockout of all B-cells, of all antibodies,  for 6-12 months.

I was told that there was probably still some B-cells hiding in tissues during those 6-12 months. Such is the competence of the most expert researchers in the world today... It is sad...

..Trevor..


ChrisMavo
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 Posted: Tue Nov 22nd, 2011 07:50

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It is sad that medical researchers continue down the path of palliation ... not cure!  It is like they feel if they stop the symptoms everything is OK ... when the underlying disease process may be accelerated by suppressing the immune system. 

I am looking forward to the video from Singapore!  :D



____________________
PLS/ALS, speech difficulty, dizziness, leg weakness, overly emotional, Ph1Aug2609,11/2012 25D-12, 11/11: 25D-10, 04/11: 25D-11, 07/10: 25D-13, 05/10: 25D-15, 11/09: 25D-20, 9/09: 25D-27, 7/09: 25D-38, 1,25D-46, Mod Ph2Oct09, 100mg Mino
leroybrown
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 Posted: Tue Nov 22nd, 2011 12:39

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If it's just about palliation, then how does chemotherapy ever get passed?

Deb



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So often times it happens that we live our lives in chains and we never even know we have the key - The Eagles
Aplastic anemia Apr/10, PRCA Jan/09, Agranulocytosis 1991
25D = 25 1,25D = 58 Aug 18/09|25D<4.8 Mar/10|10.8 Nov/12
Sep '09 q8h Nov '09 q6h
Dr Trevor Marshall
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 Posted: Tue Nov 22nd, 2011 13:05

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Chemo is an interesting topic, Deb. Chemo is handled differently. Nevertheless, a lot of chemo doesn't get approved by the FDA.

Mostly it is pressure from desperate consumers and politicians that gets the marginal drugs approved.

..Trevor..
 

leroybrown
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 Posted: Tue Nov 22nd, 2011 13:16

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Does chemo go through clinical trial?

Deb



____________________
So often times it happens that we live our lives in chains and we never even know we have the key - The Eagles
Aplastic anemia Apr/10, PRCA Jan/09, Agranulocytosis 1991
25D = 25 1,25D = 58 Aug 18/09|25D<4.8 Mar/10|10.8 Nov/12
Sep '09 q8h Nov '09 q6h
Dr Trevor Marshall
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 Posted: Tue Nov 22nd, 2011 13:53

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Yes, and after-market surveillance too.

See, for example,  http://www.businessweek.com/ap/financialnews/D9R3HU3O2.htm
 

leroybrown
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 Posted: Tue Nov 22nd, 2011 15:08

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Wow. That is sad.



____________________
So often times it happens that we live our lives in chains and we never even know we have the key - The Eagles
Aplastic anemia Apr/10, PRCA Jan/09, Agranulocytosis 1991
25D = 25 1,25D = 58 Aug 18/09|25D<4.8 Mar/10|10.8 Nov/12
Sep '09 q8h Nov '09 q6h

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