Beating a Dead Horse (NurOwn)

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KevinM

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Hi all. Got some time this chilly morning (in Florida? In April? WTF?), and I want to ask for opinions on a couple of NurOwn Ph. 3 participants and the functional improvement they continue to report to this day. Both were diagnosed more than three years ago.

A week ago I posted about the upcoming release of the Pentagon’s declassified report of recent unidentified aerial objects that defy easy explanation, and this seems to fall into the same difficult to explain category. It’s another of my long-winded posts, but you know me when I get on a roll.

So we all know what happened with the Phase 3 data, and the FDA’s rejection. Most of us are probably familiar with the subset of participants with FRS >35 that responded much better than those with lower scores. One physician analyzing the data hypothesized that had that subset been larger—26 participants got NurOwn, with 9 showing strong responses (35%), while 32 got the placebo with 5 showing response (15%) though with much less of a positive response than the ones who got the actual treatment—it very likely would have reached statistical significance, at least for that group.

This is all water under the bridge now because NurOwn will not get approved, but I rehashed this because both of the individuals that have posted several videos showing pretty dramatic improvement (at least as they report it) were in this group. The big question is whether they received the treatment or the placebo, which I would give anything to know.

So here is where my logic breaks down a bit, and it has been fueled a bit by an ongoing give and take between a PALS that has lost significant function in a year, and one of these two NurOwn trial participants. Bottom line is the PALS with fast progression is of the strong opinion that this person either has exceedingly slow progression or was misdiagnosed, and that NurOwn had nothing to do with his lack of progression/improvement. He argued that the trial was designed with injections every two months because the Phase 2 trial showed that efficacy would begin to wane after that time, and it has been about a year since these two received their last injection. Thus they should not still be getting any effect from the treatments. This assumes they did not receive the placebo, which is quite possible.

I know that everyone’s progression is different, and we have some exceedingly slow progressors on this forum that were diagnosed five or more years ago and are still functioning pretty darn well. But both of these folks have posted videos showing long term improvement (not a temporary “bump”) in certain functions, one with hand strength and the other with leg strength.

A recent video shows one of the fellows quickly going up and down stairs, even going up them backwards, which he claims was not possible three years ago. The other fellow is lifting heavy blocks with a hand that he claims had very little strength before he started the trial.

I’d love to hear opinions as to why and how actual functional improvement has apparently occurred with these two, at least as they report. I know, I know, it’s only two people, but their cases have gotten a lot of visibility and many PALS point to them as proof that Nurown is potentially transformative for some PALS.

I have my doubts about misdiagnosis, because I presume that in order to qualify for the trial they had to have confirmed ALS. That would leave one of two possibilities—either they have extremely slow progression, they are overstating their “improvements,” and NurOwn (or the placebo) really had no effect; or NurOwn actually worked long term to halt progression and even restore some function. I don’t know where they were diagnosed, their actual progression (as determined by their neurologist, not them) before the trial, etc., so there are many questions that aren’t readily available. I’d just love to hear your thoughts. Slowly warming up, Kevin
 

Nikki J

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I think mostly we will never know.

i talked to my neurologist about a different trial where someone posted video saying they improved in less than 24 hours. I didn’t believe this was possible given the disease and drug mechanism. She said they used to think placebo effect didn’t happen in ALS but now she thinks it does. I am pretty sure the person had ALS but slow progressing

I hate the frs as a measure. We need better biomarkers ( do studies people!). I have some concerns about how people reported themselves to meet the progression curve for entry. I worry it skewed the placebo arm. I only know one participant and I don’t believe she did that and I am not sure anyone consciously did but I know some of the questions on the frs can be hard to answer. it isn’t unusual for them to ask me so is it this one or that one for the choices. Or ask me at 8 am or 8 pm

slow progressing PALS respond differently I think and maybe they coincidentally hit a plateau so are staying the same even though the drug effect is gone.

we can’t know and I rather think speculation is futile and frustrating. I know this was a huge blow to the community. It certainly isn’t the first and I fear not the last
 

KimT

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I think ALS is different for each PALS. There is no prediction who will progress quickly and who will progress slowly.

I also think certain things work for subsets or even an individual.

Look at the guy who takes Leap2B Fit and Serine. Is it what he takes, his attitude, or some other variable?

That's why I never discourage PALS from pursuing natural remedies. That's why I completed my doctorate in naturopathic medicine, after stopping it for three years.

There aren't many things we can control in ALS but we can try things that have helped others. That's why I let residents practice EMGs on me. Maybe something they see in me can be applied to some other PALS. That's why I religiously get my vitamins, minerals, and gut bacteria measured each year and correct deficiencies. That's why I do everything on Dr. Amen's list for brain health.

I've spent the last year interviewing cancer patients who weren't expected to live for a book I'm publishing. The goal was to find out what gives terminally ill a purpose. I decided to include people with MS and those in chronic, disabling pain. I found one guy, right here in my condo, who was cured from Stage 4 cancer without chemo. He believes eating broccoli sprouts, which provide tons more sulforaphane than cooked crucifers, every day cured him. I was very doubtful but watched a few videos by Rhonda Patrick and think it might have worked.

All that said, I think gene blocking and stem cell treatment will eventually work, at least for some......maybe most?

In the meantime, I'm putting my money on treating myself with diet and supplements.

If they want to do further testing on me, I'll gladly let them.
 
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KevinM

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All great points, Kim. Your book sounds fascinating.

I still have trouble wrapping my head around your willingness to have had 10 EMG’s done. I had two, and that was more than enough! K
 

KimT

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If you count the three I had after my car accident in 2000, I'm well into the teens. I even got one in my neck :ROFLMAO:
 

Clearwater AL

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Kim, with you having a Doctorate Degree in Naturopathic Medicine,
should we be calling you Dr. KimT ? :) How soon will the book be available?

EMGs in the teens...? Yikes! Like Kevin, one was enough for me but he two. :)

*But for those considering a second opinion... it's worth it.

Edit: You'd be one not too bothered about getting tattoos. :) :)
 
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KimT

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Part of my post was removed by a moderator. I’m on Facebook as Kim Belden.
 

Clearwater AL

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Shoot.... I closed my Facebook account, it got hacked and my daughter's
got hacked before she passed.

My opinion, you can change your birth date on Facebook one time.
If you have it in your Bio... change it. Do not post full pictures of your
house out side. My niece had hers set to show when her and her husband
or friends were at restaurants, sites and etc. Well, that caused her to
remove that quickly. I have several family members who no longer
have Facebook accounts. My sister said, "It's become nothing more
than the National Enquirer and worse." Anywhoo....

I'm sure most have taken second thoughts about their security lately.
 

Clearwater AL

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Well, I guess this kinda follows my post above. Hope it any ain't any
of you.

*New York (CNN Business)The personal information of 500 million
Facebook users, including their phone numbers, have been posted to
a website used by hackers, cybersecurity experts say.

There are records for more than 32 million accounts in the United States,
according to Alon Gal, the CTO of cyber intelligence firm Hudson Rock.
Details in cases include full name, location, birthday, email addresses,
phone number, pictures and relationship status,

At this time this is an estimate. Cybersecurity experts are still trying
to determine the real magnitude. The breach could be more than
first estimates.*
 
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affected

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Al you do realise this breach happened in 2018 and has been circulating on the dark web since then? It is just that it has wormed its way out to the surface web now, that it has attention again? Should you be worried? Probably not. You can check if your data went swimming through several pwn checking tools and sites.
 

Clearwater AL

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Tillie, sorry... I have to take to exception your post above.

It also happened in 2019. Yes, Facebook is just acknowledging it somewhat now.
Should I be worried? The hack happened to me and my daughter.

I have since upgraded all of my security... bank, credit cards and the three credit
report companies. AND... I closed out my Facebook account.
Even with this post and the little info within, one of them may follow this
and give it test. Oh yea, no site is totally secure if your Facebook leads
back to this site.

Regardless, all the info you may have had at that time is now on the dark web
and maybe later. Facebook hasn't been too straightforward in this matter.

They (the dark web) have this info...

Details in cases include full name, location, birthday, email addresses,
phone number, pictures and relationship status.

They are smart... they don't use the info right away. They may wait a year
or more before they use it to hack whatever or whoever they may have sold
it to and they may wait... your bank info, credit cards or loans.

Since 2019 if you have changed full name, location, birthday, email addresses,
phone number, pictures and relationship status... you're probably OK.

When it comes to Facebook... it's just my opinion. Others can use it as they
feel comfortable... safe.

Edit: To some I may be coming across as paranoid. No... it's experience. The hoops
I had to jump through to straighten it out with all. Wouldn't wish it on
anyone here.
 
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