Did you know biotin was patented for stroke, too?

Biotin is an emerging therapy for the treatment of secondary progressive MS.

Did you know biotin was patented for stroke, too?

Postby cheerleader » Tue Apr 28, 2015 3:00 pm

All the internet hubbabaloo on biotin for progressive MS, but everyone is overlooking the method of action, and the fact it was patented to deal with ischemia and slowed cerebral blood flow in the MS brain.

From the patent
The invention also relates to biotin for use thereof in the treatment of ischemic stroke, in particular after the acute phase. In a specific embodiment, the invention relates to biotin for use thereof in the treatment of neurological sequelae in a patient that has suffered an ischemic stroke.




In fact, if you read the entire patent application, the method of action for high dosages of biotin in multiple sclerosis is explained--biotin is targeting the damage from ischemia. This vitamin addresses the results of decreased cerebral blood flow, which creates ischemia, oxidative stress and reduced ATP production in the brain's cells. From the patent application:

The major responsibility for the evolution of the ischemic penumbra is the status of local cerebral blood flow. It is assumed that a decrease in cerebral blood flow yields reduced ATP production and failure of Na+/K+ pumps, increasing extracellular glutamate and activating glutamate- mediated channels, ending in an increase of intracellular calcium that is deleterious for the cell. It is widely accepted that the ischemic penumbra is a target for neurorepair and neuroprotective therapies.

Once again, we see quite clearly that drug companies understand the fact that the MS brain is hypoperfused and suffering from ischemia. They know there is a vascular connection in MS, and that the damage to the MS brain is very similar to ischemic stroke.

The results of the biotin study were somewhat compelling, but I was surprised at how many people were ready to take high doses of a vitamin, without understanding the mechanism of action, or the fact that this treatment was created for a very specific type of MS--mainly optic neuropathy. In fact, the major improvements in patients in the trial were not in motor abilities, but in vision. The changes is EDSS were incredibly minor. All of this information is very specifically addressed in the patent application.


Here's more info, plus a link to the patent.
http://ccsviinms.blogspot.com/2015/04/b ... ve-ms.html

pretty interesting, huh?
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Re: Did you know biotin was patented for stroke, too?

Postby 1eye » Wed Apr 29, 2015 11:22 am

I used to belong to an aphasia group that had a lot of stroke victims in it. If you've had a stroke you will understand the need for this therapy. pwMS deserve this as well. Especially if they've become progressive, since there aren't a whack of other options. Coincidentally, it was in that group that I heard a talk given by a woman who had gone up Everest as far as Base Camp. She talked about altitude sickness, and said that a lot of climbers use Diamox for altitude sickness. When you're low on (or can't use) O2, you're in bad shape.
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Re: Did you know biotin was patented for stroke, too?

Postby marcopolo » Wed Apr 29, 2015 1:24 pm

1 point or even 0.5 depending where you are on the EDSS scale is better than nothing. The question is will there be further improvement over time.

All the participants were evaluated at 9 months and 12 months. Improvement was defined as either a decline in the Expanded Disability Status Scale (EDSS) of at least 1 point for patients who had a baseline EDSS of 5.5 or less and 0.5 points for those with an EDSS of 6 or greater, or who showed an improvement of 20 percent or more on a timed 25-foot walk.
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Re: Did you know biotin was patented for stroke, too?

Postby cheerleader » Wed Apr 29, 2015 2:18 pm

I just thought it was interesting that this drug development team acknowledged slowed blood flow and ischemic injury in the MS brain.
There are lots of ways to deal with cerebral hypoperfusion and reduced energy, and if biotin can help, that's great. Of course people with MS deserve all the help they can get!

But this is a completely different mode of therapy. It's not about immune system modulation, but repairing after ischemic injury. That's the part I found really interesting...
watching the shift to addressing the vascular connection in MS has been like watching grass grow, but at least there's some movement.
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Re: Did you know biotin was patented for stroke, too?

Postby 1eye » Thu Apr 30, 2015 4:11 pm

It seems, (if it's also a treatment for stroke damage after it's done) that this is a wonderful discovery. But I want to reiterate: the first time I had what you might things call an attack, (all my other major changes happened fairly fast, except for slow progression for example, from numbness to drop-foot), the first time it happened, I thought I might have had a stroke! Yes this points to MS being very like a small stroke. Or a series of them, with less and less recovery for each one. If this medicine works for both, then perhaps this is more of a blood-flow problem than people suspected!
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Re: Did you know biotin was patented for stroke, too?

Postby Sharon » Thu Apr 30, 2015 4:20 pm

MedDay Pharmaceutical held a webcast on Tuesday, April 28 to follow-up their presentation at the AAN Conference. If you are interested in learning about the study and Biotin directly from the principal investigator and the CEO, click on the link below and you can listen to the replay of the webcast. Unfortunately, the slides used on the webcast Tuesday are not available on the replay. Listening to the webcast should answer many of your questions.

https://webconnect.webex.com/webconnect/lsr.php?RCID=1191a51db10483479e164cbf6c885e49

MedDay will be at the European Academy of Neurology conference on June 20, 2015 to present additional data. The abstract will be available on the EAN website June 13, 2015

Sharon

p.s. I forgot to mention - a closed Facebook group has been formed BiotinForProgressiveMS@groups.facebook.com
You can mention my name if you want to join
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Re: Did you know biotin was patented for stroke, too?

Postby 1eye » Thu Apr 30, 2015 7:50 pm

You gotta download their player, etc. Also on http://sullivanweb.me/webinars/MedDay%2 ... 201443.flv :smile:
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Re: Did you know biotin was patented for stroke, too?

Postby 1eye » Fri May 01, 2015 9:23 am

1eye wrote:You gotta download their player, etc. Also on http://sullivanweb.me/webinars/MedDay%2 ... 201443.flv :smile:


I have written a quick description of the talk. No direct quotes. Apologies to those who read this when it was only partially submitted.
I have also fixed some things due to Sharon's comments, below...

This is all paraphrasing and editorial: there are no direct quotations.

The usual suspects have managed to taint only one of the MedDay group (Dr. Tourbah). Either a spy in their midst or a counter-spy maybe. Actually it's the top name on the paper, so maybe he's just being completely transparent, and collecting fees. He was the one speaking and answering questions.

BTW it's quicker to download it if you can, from either place.

They had already done one trial before this one, so they may have ongoing data, because they probably kept those patients on the drug. Same with this study and subsequent ones, which they will report at a future meeting. We will see therefore, if the improvements continue.

The primary purpose was to test effects on the Expanded Disability Scale (EDSS), and timed walking speed measurements.

He said MS might be caused by virtual hypoxia: a mismatch between energy demand and energy production, caused by the inability of mitochondria to consume oxygen. Not clear if this is limited to the brain; I think not, eventually, but maybe the divide is between brain/spine and rest of nervous system. That would mean it follows the CSF (Cerebro-Spinal Fluid) from brain to spine (it does, all the way to mice, in other experiments).

They weren't taking DMDs, introduced withing 3 years, though they could if introduced less recently, or Fampridine (improves walking speed in relapsing-remitting patients), if introduced within 3 months. The fact that these were not RR patients may mean it works for them too, indicating they are treating the same disease (relapsing and progressive diseases share the same cause).

154 patients, 1/3 placebo, had 2 adverse events in each group, with 1 suicide, not related.

13 treated patients improved by trial standards, and none in placebo group.

Twice as many patients improved in EDSS as in walking. This is because EDSS is defined more by ability to walk at all, than by speed of walking.

Number of improved patients was statistically significant. Looking at the EDSS graph, it looked like progression was halted. This means something to me because I have always said, halt the progression and I'll do the rest.

This is borne out by slight improvement overall in average EDSS.

Improvements in EDSS at 3 months continued until 9 months, with a deviation at 3 from placebo, of 67%, illustrating the end of placebo effect. Continuation of the improvement lasted for the full 9 months.

When combined with the results of the other study, the results on EDSS are similar.

For timed walking, on average the treated patients were 6 seconds faster than the placebo group. This might not seem like much, and it doesn't get me out of my walker, but I can probably do that myself once I stop backsliding. The trend looks like I will stop backsliding.

Twice as many placebo people as the treated ones, had adverse events, but biotin appears to change the results of antibody tests, so the tests themselves will have to be reconsidered for people on Biotin.

There were questions both from audience and phone calls.

The question session contained:

Will you get marketing approval?
We have to do two more studies, and then European approval, then (possibly) one more, for the US, depending on whether they like what we have done by the end of the year.

Note re Sharon's update: Are they waiting till 2017 to give the other DMD vendors a chance to make some more money before they go to market?

Any other improvements?
We are testing for them. Some look like they do improve.

Cognition?
Yes we have seen this, seems significant. Some others look good too.

Do you plan to look at relapsing-remitting? If not,why not?
Not specifically, but we do have some R-R patients in our Optic Neuritis study who have permanent ON problems, so if they improve, we will know it does not matter whether they have remissions of other symptoms or not. So we will test both. Biotin does not seem to care. It is a tough requirement, but we are hopeful.

Does it rebuild myelin, or stop progression?
Both. We think it modifies the primary disease. We aren't sure if it does both, repair myelin, and decrease virtual hypoxia, but we think it will.

Should people start buying biotin? :-)
Don't know what people will do, but reasons they shouldn't are: a) it might be toxic in those doses, especially for rabbits and pregnant women, and b) because it also seems to dramatically change the results of medical tests including thyroid and pregnancy tests. Plus medical grade biotin at these doses is more of a guarantee of purity, and even whether it is biotin at all.

Can you combine it with other DMDs?
Yes, many subjects did, with no problems.

Is your research platform able to look at CSF?
No; we couldn't ask them to have spinal taps, but research will continue.

Can you predict who will benefit?
No.
Last edited by 1eye on Fri May 01, 2015 7:36 pm, edited 1 time in total.
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Re: Did you know biotin was patented for stroke, too?

Postby Sharon » Fri May 01, 2015 11:43 am

Nice summary 1 Eye...just a few corrections and additions.

Tourbah is the Principal Investigator

The first pilot study:

MD1003’s proof of concept has been obtained in a pilot open label study1 involving 23 subjects with primary and secondary progressive MS. Results were positive with up to 90% of subjects exhibiting some clinical improvement over time.
http://www.medday-pharma.com/news-and-e ... sclerosis/

The CEO of MedDay confirmed today that the drug will not be available before 2017 (specific date unavailable because of time limitations with the approval process)

1 eye said
Should people start buying myelin


I think you meant Biotin.:-) In my opinion, the OTC Biotin should not be considered. In order to get the high dosage you are taking a quantity of tablets and we all know that OTC supplements are not all the same, plus you are high dosing yourself with the fillers used in the tablets. If someone is planning on trying the Biotin, use a reliable compounding pharmacy (send them the research)...and, of course you will need a script from a doctor to get the order. The MedDay drug has no secret ingredients in it -- it is a high dose of a pharmaceutical grade of Biotin.

i eye said

Is your research platform able to look at CSF?


This was a question I asked. I was interested to know if they used their research platform in this study. This is from the MedDay website

The SPECMET metabolomics platform screens cerebrospinal fluid (CSF) from patients with CNS disorders to identify metabolic pathways that are disrupted. The goal of this approach is to identify approved or shelved compounds that are known to target the aberrant pathway.


The answer was "no" it was not used because the patients would have had to undergo an invasive spinal tap.
IMHO - The research platform is an interesting concept and hopefully will be successful in the long term.

More to learn.....MedDay will be presenting at the EAN conference June 20, 2015. Abstract will be available on the EAN website June 13, 2015. Presentation is during one of the Oral Sessions, so this will be another opportunity for a detailed report.

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Re: Did you know biotin was patented for stroke, too?

Postby 1eye » Sat May 02, 2015 7:55 am

As I said I did all the compounding myself, and the source was at least North American, so it might be pure.
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Re: Did you know biotin was patented for stroke, too?

Postby ElliotB » Sat May 02, 2015 9:45 am

here is a source for bulk pure biotin in the USA:

http://purebulk.com/biotin-pure/


Here is a source for a capsule machine:

http://www.bulkherbstore.com/The-Capsul ... istianmama


I have not tried either and am not associated with t either company. I just found both of them on the web by doing a Google search.
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Re: Did you know biotin was patented for stroke, too?

Postby CureOrBust » Sat May 02, 2015 7:16 pm

ElliotB wrote:here is a source for bulk pure biotin in the USA:
http://purebulk.com/biotin-pure/
Good find. I looked at their site, and was interested to see the following statements in their FAQ:
Hello I was looking for bulk d-biotin. I'm not sure if this biotin would work for me, or if d-biotin and biotin are interchangeable. I believe d-biotin is synthetic. Is this biotin synthetic?
Biotin and D-biotin are interchangeable names. If you see Biotin as a name it will be D-Biotin. It is always synthetically produced as a supplement. Ours is D-Biotin.
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Re: Did you know biotin was patented for stroke, too?

Postby ElliotB » Sun May 03, 2015 2:59 am

Chris, these articles I believe answer your question:

http://www.livestrong.com/article/15633 ... nd-biotin/

http://beautynutrition.com/vitamins/bio ... in-biotin/


According to the content of the 2nd link:

"the main difference between Biotin and D-Biotin exists in their names. But in terms of content and functions, the two are inseparable. In fact, most medical experts use the two names to mean the same thing. Stereoisomers are simple molecules that contain similar molecular formula. These molecules also have the same series of connected atoms. It is also worth noting that D-Biotin is a unique stereoisomer because it is the only one that originates from nature."

Here is some interesting general info about Biotin:

http://www.nutri-facts.org/eng/vitamins ... -a-glance/
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Re: Did you know biotin was patented for stroke, too?

Postby 1eye » Sun May 03, 2015 2:50 pm

From http://www.thisisms.com/forum/chronic-cerebrospinal-venous-insufficiency-ccsvi-f40/topic26261.html#p234140 and http://www.nutri-facts.org/eng/vitamins/vitamin-b7-biotin/at-a-glance/
Vitamin B7 deficiency is extremely rare, which is probably due to the fact that biotin is synthesized by beneficial bacteria in the human digestive tract.



Groups at risk of biotin deficiency include patients maintained on total intravenous nutrition, hemodialysis patients, diabetes mellitus patients, and patients with an impaired uptake of vitamins from food. In addition, pregnancy may be associated with marginal biotin deficiency.



Symptoms include hair loss, dry scaly skin, cracking in the corners of the mouth, swollen and painful tongue, dry eyes, loss of appetite, fatigue, insomnia, and depression.


Could it be that modern antibiotics are killing off the same gut bacteria that provide natural B7 and that modern MS is somehow related to a vitamin B7 deficiency caused by excessive antibiotic use?

I suffered a bad bout of Osteomyelitis when I was 12 (interestingly, same leg that's worst now). It had only been recently that they had been treating it with antibiotics. My father had it and had to have a finger-bone operation, after which he could no longer fret a violin. In my case, they used a very long course of antibiotics. During that same time I was also on IV feeding for about 2 weeks.

What about diabetes, which my Dad had, and my brother has now (same brother who had the bone marrow transplant)?
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Virtual Hypoxia?

Postby ThisIsMA » Mon May 04, 2015 7:38 am

If I remember correctly, "virtual hypoxia" was mentioned in the Biotin study. I was curious if they meant a specific thing by that term. So I Googled "Virtual Hypoxia" +Multiple Sclerosis ...and this study popped up:

Is there anyone who would like to take a stab at trying to translate this one into plain english?

http://www.ncbi.nlm.nih.gov/pubmed/19233038

Lancet Neurol. 2009 Mar;8(3):280-91. doi: 10.1016/S1474-4422(09)70043-2.
Virtual hypoxia and chronic necrosis of demyelinated axons in multiple sclerosis.
Trapp BD1, Stys PK.
Author information

1Department of Neurosciences, Cleveland Clinic, Cleveland, OH 44195, USA. trappb@ccf.org
Abstract
Multiple sclerosis (MS), an inflammatory demyelinating disease, is a major cause of neurological disability in young adults in the developed world. Although the progressive neurological disability that most patients with MS eventually experience results from axonal degeneration, little is known about the mechanisms of axonal injury in MS. Accumulating evidence suggests that the increased energy demand of impulse conduction along excitable demyelinated axons and reduced axonal ATP production induce a chronic state of virtual hypoxia in chronically demyelinated axons. In response to such a state, key alterations that contribute to chronic necrosis of axons might include mitochondrial dysfunction (due to defective oxidative phosphorylation or nitric oxide production), Na+ influx through voltage-gated Na+ channels and axonal AMPA receptors, release of toxic Ca2+ from the axoplasmic reticulum, overactivation of ionotropic and metabotropic axonal glutamate receptors, and activation of voltage-gated Ca2+ channels, ultimately leading to excessive stimulation of Ca2+-dependent degradative pathways. The development of neuroprotective therapies that target these mechanisms might constitute effective adjuncts to currently used immune-modifying agents.

PMID: 19233038 [PubMed - indexed for MEDLINE]
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