tag:blogger.com,1999:blog-42840163382235657582023-11-15T08:41:52.037-08:00Brain Tools BlogA project to get a remarkable new drug for revival of memory in Alzheimer's patients.Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.comBlogger9125tag:blogger.com,1999:blog-4284016338223565758.post-83412544215568923832013-05-06T15:45:00.002-07:002013-05-06T15:45:53.728-07:00<div class="uiStreamMessage userContentWrapper" data-ft="{"type":1,"tn":"K"}">
<span style="font-size: small;"><span style="font-family: Verdana,sans-serif;"><span class="messageBody" data-ft="{"type":3}"><span class="userContent"><span style="font-weight: normal;">Brain-Tools has partnered up with a newly established non-profit group called <a href="http://www.hopeforalzheimers.org/" target="_blank">Hope for Alzheimer's</a> to help get MSF to patients. This group was established by Doug Person, Greg Murray, and Margie Bachman to raise funds for research and development of treatments for Alzheimer's. The group is in the process of filing for </span></span></span><span class="messageBody" data-ft="{"type":3}"><span class="userContent"><span style="font-weight: normal;"><span>501(c)(3) charity tax designation which will go through by the end of the year, giving donors a tax write off for their contribution. This contribution will then go to help pay for the advanced safety studies and clinical trials yet needed to get MSF to people with Alzheimer's disease.</span></span></span></span></span></span></div>
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<span style="font-size: small;"><span style="font-family: Verdana,sans-serif;"><span class="messageBody" data-ft="{"type":3}"><span class="userContent"><span style="font-weight: normal;"><span>What's more, because Brain-Tools is intended to sell MSF for a profit we will pay every dime we receive back to the organization on completion of the project. This money will then be redistributed to a new Alzheimer's research project working on a true cure for Alzheimer's! This means that if all goes well, you not only receive a tax write off for your donation, but the donation will get used twice, effectively doubling it.</span></span></span></span></span></span></div>
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<span class="messageBody" data-ft="{"type":3}"><span class="userContent"><span style="font-weight: normal;"><span style="font-family: Verdana, sans-serif;"><span style="font-size: small;"><span><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;">To check out the Hope for Alzheimer's Foundation website go to http://www.hopeforalzheimers.org/.</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span> </span></span></div>
Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com0tag:blogger.com,1999:blog-4284016338223565758.post-20606494637927964002013-04-26T13:43:00.000-07:002013-04-26T13:43:12.616-07:00FDA Discussions<span style="font-family: Verdana, sans-serif;">I mentioned a little while ago that we had been in contact with the <a href="http://www.fda.gov/Drugs/default.htm" target="_blank">FDA</a> about getting some advice on our clinical trial design. That's progressed a bit with some emails back and forth.</span><br />
<br />
<span style="font-family: Verdana, sans-serif;">We also managed to get in contact with <a href="http://en.wikipedia.org/wiki/Ron_Wyden" target="_blank">Senator Ron Wyden</a> (OR) who sits on the funding committee of the <a href="http://www.fda.gov/Drugs/default.htm" target="_blank">FDA</a> as well as the committee on aging. <a href="https://brain-tools.com/march17_030.htm" target="_blank">Dr. Summerton</a> had dinner with him last Friday and he agreed to help us get in contact with the people we need to talk to at the FDA.</span><br />
<br />
<span style="font-family: Verdana, sans-serif;">Lo and behold last night <a href="https://brain-tools.com/march17_030.htm" target="_blank">Dr. Summerton</a> received a phone call from the <a href="http://www.fda.gov/Drugs/default.htm" target="_blank">FDA</a> asking about our project.</span> <br />
<br />
<span style="font-family: Verdana, sans-serif;">Getting advice from the FDA in our experimental design is absolutely vital in keeping the costs down while simultaneously running an experiment that complies with the quality requirements of the Food and Drug Administration.</span><br />
<span style="font-family: Verdana, sans-serif;"> </span><br />
<span style="font-family: Verdana, sans-serif;">In the meantime Dr. Moss is trying to get in contact with <a href="http://en.wikipedia.org/wiki/Rick_Perry" target="_blank">Governor Rick Perry</a></span> <span style="font-family: Verdana,sans-serif;">(TX)</span> <span style="font-family: Verdana, sans-serif;">To help with a funding proposal to the states while Dr. Summerton has been in contact with <a href="http://www.johnkitzhaber.com/" target="_blank">Governor John Kitzhaber</a></span> <span style="font-family: Verdana, sans-serif;">(OR) to also provide advice on how to level a proposal to the 50 states.</span><br />
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<span style="font-family: Verdana, sans-serif;"><br /></span>Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com2tag:blogger.com,1999:blog-4284016338223565758.post-33175129141073957972013-04-23T14:18:00.003-07:002013-04-23T14:18:51.659-07:00Our First Spot on Television<span style="font-family: Verdana, sans-serif;">The <a href="http://www.kvia.com/" target="_blank">KVIA station</a> in El Paso Texas picked up our story yesterday. <a href="http://www.kvia.com/-/391190/538010/-/g0suct/-/index.html" target="_blank">Whitney Burbank </a>called up Brain-Tools at about two pm looking for Dr. Moss' phone number, and the story ran on the 10:00 news. It was a remarkably fast turnaround and a very well done story. </span><br />
<br />
<span style="font-family: Verdana, sans-serif;">You can watch the story at their website <a href="http://www.kvia.com/news/Former-UTEP-prof-determined-to-market-revolutionary-affordable-Alzheimer-s-drug/-/391068/19855666/-/ramp57/-/index.html" target="_blank">here</a>.</span>Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com1tag:blogger.com,1999:blog-4284016338223565758.post-17918275493193379472013-04-12T14:22:00.002-07:002013-04-12T14:22:54.856-07:00New Crowdfunding Site: We can take Credit Cards Now!<span style="font-family: Verdana,sans-serif;">We have started up a Brain-Tools crowd funding page over at <a href="http://www.rockethub.com/projects/23464-alzheimer-s-treatment-clinical-trial-for-methanesulfonyl-fluoride" target="_blank">Rockethub</a> to collect contributions to the MSF development project. This site is set up to help fund new start up projects by public contribution, just as we had intended to do with our treatment for Alzheimer's. Our first fundraising goal is $100,000 collected over 90 days which will go to developing our memory tests and pay for equipment we'll be using to safely manufacture MSF for our long term safety study (the second stage described in our <a href="http://www.brain-tools.com/march17_035.htm" target="_blank">funding plan</a>).</span><br />
<br />
<span style="font-family: Verdana,sans-serif;">Please take a moment to help us with the first leg of our crowd funding push to make MSF available to Alzheimer's patients. Share this site with anyone that would have interest in a more effective treatment for the debilitating effects of memory loss caused by this disease.</span><br />
<br />
<span style="font-family: Verdana,sans-serif;"><a href="http://rkthb.co/23464" target="_blank">Brain-Tools Crowdfunding Project</a> </span>Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com1tag:blogger.com,1999:blog-4284016338223565758.post-73384589158441996662013-04-11T12:09:00.001-07:002013-04-11T12:09:29.297-07:00Podcast on Alzheimer's Speaks Radio<span style="font-family: Verdana, sans-serif;">Dr. Moss gave an interview on Alzheimer's speaks radio today which you can listen to below on his experiences with developing MSF and how we plan to proceed from there. You can also listen to the interview on the Alzheimer's speaks site <a href="http://www.blogtalkradio.com/alzheimersspeaks/2013/04/11/dare-to-care--daily-living-research" target="_blank">here</a>. The interview with Dr. Moss begins at 61:34.</span><br />
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Listen to <a href="http://www.blogtalkradio.com/">internet radio</a> with <a href="http://www.blogtalkradio.com/alzheimersspeaks">Alzheimers Speaks Radio</a> on Blog Talk Radio<br />
<br /></div>
Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com2tag:blogger.com,1999:blog-4284016338223565758.post-67653010748270817052013-04-08T09:37:00.000-07:002013-04-08T09:37:09.720-07:00<br />
<h3 style="text-align: center;">
<span style="font-family: "Verdana","sans-serif"; font-size: 14.0pt; line-height: 115%;">Assays
for Memory Improvement After Treatment with MSF in Alzheimer's Patients</span></h3>
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<span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; line-height: 115%;"> I had the
opportunity to see the memory assays we'll be giving to Alzheimer's patients to
assess their improvement, and I loved them. They were easy to understand, could
be given quickly without too much strain on the subject, and the peer reviewed
research indicated they were exceptionally good at discerning memory abilities
in both Alzheimer's patients and normals. The tests were researched by <a href="http://psychweb.uoregon.edu/people/awh-edward" target="_blank">Dr. Awh</a>
and <a href="http://psychweb.uoregon.edu/people/vogel-edward" target="_blank">Dr. Vogel</a>, and they are currently working on formatting the tests so that
they can be given remotely by trained testers over Skype or a similar sort of
software. This is pretty important if you're going to be testing 400 people a
week over a potentially very large area. Of course in addition to these quick
assessments our Contract Research Organizations (CROs) will also be using the
same methods that <a href="http://www.aricept.com/" target="_blank">Aricept</a> used to test donepezil on a roughly monthly basis so
that our they can determine relative effectiveness of the drugs.<o:p></o:p></span></div>
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<span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; line-height: 115%;"><br /></span></div>
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<span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; line-height: 115%;"> In the
meantime <a href="http://brain-tools.com/march17_030.htm" target="_blank">Dr. Summerton</a>, co-manager of <a href="http://brain-tools.com/" target="_blank">Brain-Tools</a>, has written our first letter
to the FDA about helping us set up Adaptive trials, and we just got our first
responses! Details will be forthcoming.<o:p></o:p></span></div>
Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com1tag:blogger.com,1999:blog-4284016338223565758.post-81838367205490072452013-04-05T10:40:00.001-07:002013-04-05T10:40:15.183-07:00Getting the Word Out<h2 style="text-align: center;">
<span style="font-family: Verdana, sans-serif;">Website Completed</span></h2>
<div class="MsoNormal">
<span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; line-height: 115%;"> Although
we've been tweaking it a bit here and there, the website has been pretty much
completed, with all of the information on our project to get MSF to Alzheimer's
patients available now. One of the key features up there right now is an
animation Jon Perry of Stated Clearly created for us to explain the mechanism
of MSF's restoral of memory in sufferers of Alzheimer's. The animation explains
why MSF performs so remarkably compared to what's available on the market, and
does so for a general audience.<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; line-height: 115%;"> With the
completion of the website we've started focusing on how to best disseminate our
project to the public. Because we rely on contributions from the public as
opposed to traditional venture capitalists we have a lot more stake in having
our project heard about by private individuals. Whereas a mainline
Biopharmaceutical company might put out a few press releases to drum up
enthusiasm in their existing investors, we need everyone with a stake in
Alzheimer's treatments to hear about us. Currently Dr. Moss is working with a
PR consultant and some volunteer assistance from his daughters to write letters
to talk shows, podcasts and blogs asking if they'll share our story. We should
start sending the letters out within the next few days, so check back here to
see if we end up on anything you listen to. </span><span style="font-family: Verdana, sans-serif; font-size: 12pt; line-height: 115%;">If you have any suggestions for slightly obscure
podcasts or talk shows we should write to, please send them to me at
patrick.summerton@brain-tools.com.</span></div>
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<span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; line-height: 115%;"><br /></span></div>
<div class="MsoNormal">
<span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; line-height: 115%;">And now for the video I was touting in the first
paragraph!<o:p></o:p></span></div>
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</object>Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com4tag:blogger.com,1999:blog-4284016338223565758.post-84023171073089736642013-02-27T12:48:00.003-08:002013-02-27T12:50:27.039-08:00How do we prove to the FDA that MSF Works?<div class="MsoNormal" style="line-height: 150%;">
<span style="font-family: Arial, sans-serif; font-size: 12pt; line-height: 150%;"> This was a pretty crucial question
to answer. Without having a good idea of how to show quantitative memory
improvement, an Alzheimer's treatment would be dead in the water, and while Dr.
Moss had designed numerous experiments as well as run a clinical trial for
efficacy, all of these were with small samples. The testing for memory
improvement needed to be streamlined so that we could easily collect data on as
many as two hundred subjects through quick and easy tasks that wouldn't put too
much strain on either the Alzheimer's patient or their caretaker.</span> <span style="font-family: Arial, Helvetica, sans-serif;">One of
the big concerns when running large scale trials is that if your tests are too
onerous, you'll have a large dropout rate and may end up with an insufficiently
representative sample to satisfy a regulatory body like the FDA.</span><o:p></o:p></div>
<div class="MsoNormal" style="line-height: 150%;">
<span style="font-family: Arial, sans-serif; font-size: 12pt; line-height: 150%;"> With this in mind we contacted <a href="http://psychweb.uoregon.edu/~pk_lab/awh.htm" target="_blank">Dr.Edward Awh</a> and <a href="http://psychweb.uoregon.edu/~pk_lab/vogel.htm" target="_blank">Dr. Edward Vogel</a> at the University of Oregon. Both Eds have
existing labs that study visual working memory and attention, two major
faculties damaged by the progression of Alzheimer's disease. They accepted the
task of putting together FDA compliant tasks that could demonstrate a change in
a person's basic physiological ability to remember things, even after repeated
exposure to the same procedure (ie, they can account for the learning effect).<o:p></o:p></span></div>
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<span style="font-family: Arial, sans-serif; font-size: 12pt; line-height: 150%;"><br /></span></div>
<div class="MsoNormal" style="line-height: 150%;">
<span style="font-family: Arial, sans-serif; font-size: 12pt; line-height: 150%;">Excerpted from
an email to me by Dr. Vogel:<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%;">
<span style="background-color: white; background-position: initial initial; background-repeat: initial initial; font-family: Arial, sans-serif; font-size: 12pt; line-height: 150%;">...<o:p></o:p></span></div>
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<i><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; font-family: Arial, sans-serif; font-size: 12pt; line-height: 150%;">The plan for assessing the efficacy of MSF by
testing memory functioning in Alzheimer's patients.</span></i><i><span style="font-family: Arial, sans-serif; font-size: 12pt; line-height: 150%;"><br />
<br />
<br />
<span style="background: white;">Our general plan for doing this involves two basic
components:</span><br />
<span style="background: white;">1. Clinician-administered tests (once every 3-4
weeks during the study) which will include the ADAS-Cog (a battery of cognitive
tests for alzheimer's that has been the standard measure in nearly all clinical
trials of cholinesterase inhibitors); and one or two questionnaires regarding
Daily living activities and function to be filled out by the patient and
caregiver. These tests should take approximately 45mins to 1 hr to complete.</span><br />
<br />
<br />
<span style="background: white;">2. Remotely-administered tests via computer (once
per week during the study) of memory and cognition which will include
assessment of picture memory, paired-association with words, delayed free
recall of words, and the COWAT (Controlled Oral Word Association Test) which
measures the individual's ability to fluently generate words of a particular
type (e.g., say all the words you can think of that start with the letter
"F"). Together, these tests will take approximately 20mins to
complete.<span class="apple-converted-space"> <span class="apple-converted-space"> </span></span></span><br />
<br />
</span></i><i><span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 150%;">...<o:p></o:p></span></i></div>
<div class="MsoNormal" style="line-height: 150%;">
<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 150%;"> He ended the email suggesting that they should be
finished with the test development process by the end of March, putting us well
on schedule to proceed as soon as the long term, FDA compliant toxicity studies
are completed.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%;">
<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 150%;"><br /></span></div>
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<span style="font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 150%;">I'll admit I'm kind of
curious to take one of these memory tests myself. I'll probably keep the
results confidential though.<o:p></o:p></span></div>
Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com0tag:blogger.com,1999:blog-4284016338223565758.post-57692028161678029192013-02-08T10:25:00.000-08:002013-02-08T10:25:10.574-08:00The Story So Far<br />
<div class="MsoNormal">
<span style="font-family: Arial, sans-serif;"><span style="line-height: 115%;">There are about thirty years of backstory to this project
which you should read about either in </span></span><a href="http://www.amazon.com/ALZHEIMERS-JOURNEY-NEXT-GENERATION-TREATMENT/dp/1481118315" style="font-family: Arial, sans-serif; line-height: 115%;" target="_blank">Dr. Moss' book</a><span style="font-family: Arial, sans-serif;"><span style="line-height: 115%;">, or for a quick overview,
in the excerpts section on the </span></span><a href="http://www.brain-tools.com/" style="font-family: Arial, sans-serif; line-height: 115%;" target="_blank">brain-tools website</a><span style="font-family: Arial, sans-serif;"><span style="line-height: 115%;">. The part where we (</span></span><a href="http://www.brain-tools.com/" style="font-family: Arial, sans-serif; line-height: 115%;" target="_blank">braintools</a><span style="font-family: Arial, sans-serif;"><span style="line-height: 115%;">) came into the
picture, however, was in October of 2012. Dr. Moss and Dr. Summerton had
already agreed to collaborate on finally turning the drug Dr. Moss had
developed and tested into a workable treatment for memory loss in Alzheimer's
patients. The trouble that's faced Dr. Moss over so many years was the lack of
patent protection afforded to the MSF drug, making it cost-prohibitive for any
big pharmaceutical company to carry through a 100 million dollar phase three
clinical trial, despite its unprecedented efficacy in restoring the memories of
Alzheimer's patients. Dr. Summerton had discovered a long forgotten
congressional bill called the Orphan Drug act, passed in 1983, which was
developed for the specific purpose of getting highly useful, but non profitable
drugs on the market. The bill was originally developed to cover drugs that
treated life threatening illnesses that affected a very small patient base like
Muscular Dystrophy, but since has been expanded to cover any drug that can
provide great social benefit but not enough profit to cover the costs of
clinical trials. The Orphan Drug act mandates that the FDA collaborate with
drug development groups to help minimize the cost of clinical trials and
streamline the process, while simultaneously offering a seven year </span><span style="line-height: 18px;">guarantee</span><span style="line-height: 115%;"> of
protected market status to help recoup losses. For us this ends up being four
years of market protection as phase two and three clinical trials are expected
to take about three years.<o:p></o:p></span></span></div>
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<span style="font-family: Arial, sans-serif; line-height: 115%;"><br /></span></div>
<div class="MsoNormal">
<span style="font-family: Arial, sans-serif;"><span style="line-height: 115%;">Because major pharmaceutical companies have passed on the
drug, we at brain-tools may be the last hope to get MSF (<a href="http://en.wikipedia.org/wiki/Methanesulfonyl_fluoride" target="_blank">Methane SulfonylFluoride</a>) into the market. Our plan is discussed in detail here, but the key
element is the reliance on crowd funding instead of a traditional equity
investment. With funds raised through contributions we will not be </span><span style="line-height: 18px;">accruing</span><span style="line-height: 115%;"> large debt to venture capitalists. Between this and the reduced costs of
clinical trials through the Orphan Drug Act we can offer a contractual </span><span style="line-height: 18px;">guarantee</span><span style="line-height: 115%;"> that we will keep prices of MSF affordable to everyone, even those
without health insurance or on social security. This is a </span><span style="line-height: 18px;">guarantee</span><span style="line-height: 115%;"> that other
avenues of drug development cannot offer. Perhaps an even bigger advantage of
this method is that it will open the path for other companies to follow a
crowd funding/<a href="http://en.wikipedia.org/wiki/Orphan_Drug_Act_of_1983" target="_blank">Orphan Drug</a> act model, allowing other potentially lifesaving drugs
that have fallen through the cracks to make it into the market.<o:p></o:p></span></span></div>
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<span style="font-family: Arial, sans-serif; line-height: 115%;"><br /></span></div>
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<span style="font-family: Arial, sans-serif; line-height: 115%;">It's an exciting prospect, to say the least.<span style="font-size: small;"><o:p></o:p></span></span></div>
Anonymoushttp://www.blogger.com/profile/02434961801978618261noreply@blogger.com0