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Saturday, January 18, 2014

National MS Society Public Service Announcement



Multiple sclerosis destroys connections. It disconnects the mind from the body and people from each other. Defy this disease with the very thing it seeks to destroy: connections.



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Thursday, January 16, 2014

Alemtuzumab Investigators Protest FDA Decision

PLEASE read all AND THEN CLICK ON THE LINK FOUND 
AT THE BOTTOM OF THIS PAGE


Medscape
January 16, 2014

By Sue Hughes

Several multiple sclerosis (MS) experts who were involved in the clinical development program for alemtuzumab (Lemtrada, Genzyme) have voiced their disappointment and frustration over the recent decision by the US Food and Drug Administration (FDA) not to approve the drug.

Stephen Krieger, MD, from Mount Sinai Medical Center, New York; Edward Fox, MD, from the Multiple Sclerosis Clinic of Central Texas, Round Rock; and Jeffrey Cohen, MD, from Cleveland Clinic, Ohio, all told Medscape Medical News that they strongly disagree with the FDA decision and are worried about the consequences, which could include patients sourcing the drug from other countries but not being monitored for the serious safety issues.

"It's a huge enterprise to do these trials," Dr. Krieger commented. "A lot of doctors are involved, and we have all seen patients do extremely well who probably wouldn't have done so without alemtuzumab. There is a lot of disappointment among MS specialists."

The company announced that FDA had declined approval for alemtuzumab on December 27, saying that Genzyme had not submitted evidence from adequate and well-controlled studies demonstrating that the benefits of alemtuzumab outweigh its serious adverse effects. The concerns are understood to relate to the open-label design of the 2 phase 3 Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis trials, CARE-MS I and CARE-MS II.

The agency has also stated that 1 or more additional active comparator clinical trials of different design and execution are needed for approval.

"Genzyme strongly disagrees with the FDA's conclusions and plans to appeal the agency's decision," the company said in a statement released December 30 after the FDA issued a Complete Response Letter.

Prior to that, the drug was the subject of an advisory panel meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which did not reach a clear consensus. Dr. Krieger told Medscape Medical News that he thought the advisory panel was in favor of approval. "The spirit of the panel was that it was approvable," he said.

But chair of that advisory committee, Nathan Fountain, MD, University of Virginia, Charlottesville, defended the FDA's decision.

"It is likely that the FDA did not approve alemtuzumab for MS because some adverse events that occurred were potentially fatal; in addition, some of them did not occur for years after administration of the drug," Dr. Fountain told Medscape Medical News. "It would be very difficult to insure that patients would be monitored for these problems for an adequate duration."

Many MS researchers looking at the data to date with this drug had been hopeful that the dosing schedule of 2 treatments a year apart, with many patients apparently not requiring any further treatment, might represent an opportunity to move MS into the category of a controlled chronic disease. Others had even used the "C" word — cure — in discussions of its potential impact.

"If alemtuzumab were truly curative, then I imagine the benefits might outweigh the risks," Dr. Fountain said. "However, the clinical trials submitted did not allow determination of whether alemtuzumab altered the natural history of MS. Only through a longer, well-designed, double-blind, randomized, adequately powered study could it be determined whether alemtuzumab is curative.

"Although this type of study is not popular among industry or NIH [National Institutes of Health] sponsors, a curative therapy for MS would be worth the seemingly high risk of a drug like alemtuzumab and would represent a foundational breakthrough in MS therapy," Dr. Fountain concluded.

While the advisory panel did not appear to reach a clear consensus, the assessment of FDA's own reviewers, released before the meeting, was more clear, bordering on blunt. In documents provided to the panel in advance of the meeting, Billy Dunn, MD, acting deputy director of the Division of Neurology Products, summarizes 3 reports from reviewers: from Evelyn Mentari, MD, of the drug's safety; from John Marler, MD, of its clinical efficacy, and from Sharon Yan, PhD, of the clinical statistics supporting the supplemental Biologics License Application for alemtuzumab.

"As discussed by Drs. Mentari, Marler, and Yan, significant concerns exist regarding the safety profile of alemtuzumab and the adequacy of the efficacy data," Dr. Dunn says in the memo.

Playing Politics?

For his part, Dr. Fox believes the issue is more about Genzyme not following FDA requests.

"I knew the FDA had an issue regarding trial design," he said. "There had been a large amount of communication between Genzyme and the FDA which I thought had been resolved. But it appears that the FDA wanted a double-dummy design, Genzyme didn't do it, and now the FDA is putting its foot down. They appear to be making a point. But I don't believe they ever said the drug would not be approved with that trial design. They allowed it to be filed and fast tracked."

Dr. Fox says he "isn't taking no for an answer" at the moment, and he is organizing an open letter from the alemtuzumab investigators to the FDA explaining the reasons for the trial design and the need for the drug. "Individuals from the FDA made this decision, but they cannot dispute the overriding nature of the results. I want this drug available for patients with aggressive MS," he commented.

 Individuals from the FDA made this decision, but they cannot dispute the overriding nature of the results. I want this drug available for patients with aggressive MS.

Dr. Fox was a member of the international steering committee for the development program for alemtuzumab and an investigator in the phase 2 and both phase 3 trials of the drug. He says the steering committee included specialists from many different countries, and there was international consensus on the study design.

Dr. Krieger, who was a site principal investigator for the CARE-MS 2 trial, takes a similar view. "The FDA did request several times that Genzyme conduct the studies with a double-dummy design, but Genzyme set a higher bar of efficacy by using an active comparator and that in itself made a double-dummy design difficult. But why then did the FDA let them go ahead and give them fast track status for the drug approval process?"

The FDA concerns revolve around the fact that the patients were not blinded, Dr. Krieger explains. But he maintains this was accounted for by other factors. "There were blinded evaluators and there were regular assessments to make sure the evaluators remained blinded."

Dr. Cohen echoes these opinions. "The open design of the study was very vigorously discussed on the steering committee of the CARE-MS program, of which I was a member. The hypothetical concerns about bias are well known," he said.

"I have 2 disagreements with the FDA," Dr. Cohen added. "I don't think the double-dummy design would have been feasible as patients would know which drug they were on because of the side effects. And there was enough evidence presented to assuage the concerns about bias."

Dr. Krieger made the point that alemtuzumab is given as an infusion over a few days, whereas interferon β-1a (Rebif, EMD Serono/Pfizer) is administered as an injection 3 times a week, so a double-dummy trial would involve patients being given sham injections 3 times a week for the 2-year trial period or undergoing a sham infusion for several days, which he said was "impractical and unethical."

"Every single person knows what drug they are on, even with a double dummy," Dr. Fox agreed. "With all the effort involved to make a double dummy happen, it would have been a sham."

He further pointed out that most other MS drugs have been tested against placebo, which makes blinding easier. "Because of safety concerns with alemtuzumab, it was felt that the only way to justify its use was to compare with an active drug routinely used for MS. This is a higher standard than applied to any other MS drug, but it is this that has caused them problems because of the lack of blinding. But alemtuzumab is very clearly more effective than Rebif on reducing relapses, slowing disability, and reducing MS lesions on MRI."

Alemtuzumab is already approved in the European Union, Canada, and Australia, and additional marketing applications are under review by other regulatory agencies.

All 3 experts were also uncomfortable about the situation that may now arise, with alemtuzumab being available in Canada and Europe but not in the United States. They point out that this could lead to unsupervised use and big safety concerns.

Dr. Krieger commented: "It is highly likely that some patients will travel to Canada to get it. It is relatively easy to undergo the 2 single administrations 1 year apart in a different country, but the problem is that there won't be any safety programs set up in the US to monitor patients. This drug has some dangerous side effects. Patients need to be monitored closely. This won't happen if they get the drug abroad. This is a very risky situation."

"This was never going to be a medicine for everyone but it is a powerful product for those with the most active form of MS," he added. "And there is a big unmet need here. But these are not the patients I would choose to send to another country for treatment. These are the patients I would want to keep close."

Recent experience with the use of angioplasty to address chronic cerebrospinal venous insufficiency (CCSVI) in MS shows without a doubt that knowledgeable, motivated patients with MS have been known to take matters into their own hands. After the first studies relating to a possible link between CCSVI and MS came out, hundreds of patients used their own resources to fly to centers, sometimes in different countries, to obtain treatment despite the lack of data to support efficacy or safety, and issues with follow-up care once they returned.

One possible scenario now would be that MS centers in the United States may collaborate with hospitals in Canada or Europe and together offer a program under which, if a patient obtains alemtuzumab treatment in a country where it is available, they will undergo monitoring back home at the US hospital.

Dr. Cohen says he has discussed this very possibility. "That is not an ideal situation but it would be feasible if it is the only option," he added.

The National Multiple Sclerosis Society, which describes itself as a "collective of passionate individuals who want to do something about MS now," testified before the FDA advisory committee on alemtuzumab, addressing "the need for more therapeutic options for people with MS and the importance of empowering people with MS to make their own informed treatment decisions," the society notes in a statement reacting to the FDA's decision not to approve alemtuzumab.

"This is disappointing news, given the need for more therapeutic options for people with MS living in the United States," Timothy Coetzee, PhD, chief advocacy, services and research officer at the National Multiple Sclerosis Society, said in the statement.

"The Society will continue to monitor this process and update its constituents of any news," the release concludes.




MEANWHILE – PLEASE click  HERE





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Wednesday, January 15, 2014

Biogen Idec Announces Availability of FAMPYRA® in Ireland to Treat Walking Impairment in Adults with Multiple Sclerosis

MAIDENHEAD, England & DUBLIN, Jan 15, 2014 (BUSINESS WIRE) -- Biogen Idec today announced that FAMPYRA® (prolonged-release fampridine tablets) has been made available in Ireland for the symptomatic treatment of walking impairment in adults with Multiple Sclerosis (MS). FAMPYRA is a prescription drug and is licensed for use in all types of the disease, including the progressive forms. FAMPYRA is available by way of retail pharmacy on a private payment basis. FAMPYRA is not currently available for reimbursement through any of the Health Service Executive’s (HSE’s) payment schemes.
“We are very pleased that FAMPYRA is now available for use in Ireland”, said Terry O’Regan, Vice President & Managing Director of Biogen Idec Ltd. “As a leading company in MS, we feel a strong sense of obligation to the MS community to bring new and innovative therapies to the people that need them, and we’re absolutely delighted to be able to offer this new treatment option for MS patients with walking disability.”
“Walking and mobility are the number one concerns for people with MS, so a therapy that potentially offers an improvement is a valued and welcomed addition to the treatment options available”, saidDoctor Christopher McGuigan, Consultant Neurologist, St. Vincent's Hospital, Dublin.
Dr. McGuigan is one of a number of healthcare professionals in Ireland who has previous experience with FAMPYRA as a participant in clinical trials, and via the Named Patient Supply programme.
In clinical trials, FAMPYRA demonstrated efficacy in improving walking speed. In the pivotal MS-F203 phase III study by Goodman et al, around 35% of patients taking FAMPYRA responded to treatment compared with 8% of patients taking placebo1. In the second study, the results were similar with 43% of patients in the FAMPYRA group responding to treatment compared with 9% in the placebo group2.
FAMPYRA is not reimbursed by the Health Service Executive (HSE), however, Biogen Idec is providing up to four weeks’ treatment of FAMPYRA at no cost, enabling clinicians and patients to trial the product and assess its effectiveness before committing to pay for treatment. Treatment effect is usually evident between two to four weeks.
FAMPYRA is currently available throughout most of Europe.
About FAMPYRA

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Two High-Profile Multiple Sclerosis Treatments Receive Criticism From Governmental Drug Administrations

Jan 14, 2014

When it comes to drug development, the unmet need of crafting viable, effective Multiple Sclerosis treatments continues to be a major issue. The disease continues to increase throughout the world, with more than two million people presenting with some firm of MS. Most recently, two prominent treatments for Multiple Sclerosis received a vote of no-confidence from governmental drug administrations, indicating that the search for viable MS treatments still has a long way to go.
A report from last week indicated that the U.S. Food and Drug Administration rejected the Multiple Sclerosis treatment Lemtrada, on the basis that the drug has failed to demonstrate a high enough level of efficacy, particularly compared with its potential side effects and danger to the patient. Alemtuzumab, the generic name for the drug, is currently approved in the United States for the treatment for B-cell chronic lymphocytic leukemia (CLL). Used under the trade name under the Campath, even in this application, its use is highly limited for only “compassionate-care” situations. The drug is manufactured by Sanofi via its Genzyme production unit, which was pushing for the FDA to approve the drug for treatment for relapsing forms of MS. “Relapsing-Remitting Multiple Sclerosis” is often associated with the early onset of the disease.  The FDA argued that, particularly for this type of Multiple Sclerosis treatment designation, Lemtrada ”has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects,” and has called for a new round of clinical trials for the drug before it will be considered again for public use in the United States. Lemtrada (alemtuzumab) is currently approved in the EU and other countries as a Multiple Sclerosis treatment.

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Options and Choices - The Will of the People - Be Heard

Thousands of Multiple Sclerosis patients are getting worse each day; They need another Option, another choice


I created a petition


The drug (LEMTRADA) was recently been approved in Canada, Australia and Europe, but was denied late last year (December 2013) by the FDA



To be delivered to FDA Drug Info and Ms. Glendolynn Johnson, Peripheral and Central Nervous System Drugs Advisory Committee
We seek an FDA reversal on their December 30, 2013 decision to NOT approve Sanofi’s Lemtrada, a Multiple Sclerosis Treatment. Patients needs this Medication-option Approved

PETITION BACKGROUND


Thousands of Multiple Sclerosis patients are getting worse each day, when currently used medications are not working for them or their body refuses to accept the medication.

Another Option is needed and this Option Should be Lemtrada

The FDA on December 30, 2013 Denies the use of Lemtrada for MS Patients. THIS was A sad day for people with more active Multiple Sclerosis.

Lemtrada has been approved worldwide, but not good enough for us it seems, in the USA.

We are more than 400,000 strong (living with MS) in the USA
WE NEED YOUR VOTE to give another OPTION to those that Can benefit from this medication; hoping to keep them from severe disability.

YES, WE NEED YOUR VOTE.


Will you sign this petition? Click here:

http://petitions.moveon.org/sign/thousands-of-multiple?source=c.em.mt&r_by=9834412

Seriously – We need to Try to get the FDA to Reverse their decision.. A decision that one day, might affect you or someone you know.

Your vote is needed

PLEASE SIGN and SHARE with everybody in your address book , and ask them to share with their address books too

• Let us FLOOD the OFFICE of this FDA committee with responses for this petition that asks for another treatment option... 


Thank you    

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Tuesday, January 14, 2014

What's the "skinny" on when and why the FDA decided to regulate the cells in your body a drug?!

Published by : Jennifer Ziegler

In the 1990's The FDA encroached into the practice of medicine, making adult stem cell therapy subject to the same regulatory over site as mass produced pharmaceutical drugs. They did this without compliance to the, "administrators procedures act," which involves an extensive public comment period. This unprecedented power grab buy the FDA stated,  if your cells were expanded in any way they were considered drugs, even though they were still your cells. The FDA without proper notice to the public made a one word "midnight language change," in the federal registry.  It changed a single word from "another" to "A." It's regulatory authority was initially put in place to control communicable diseases during organ transplants. Because of this language change, the FDA's regulatory authority was expanded from simple control over someones cells used as a transplant from, "another," person,  to all cells from "A," person. This one word change gave the FDA sweeping new authority over the cells in your body.  Here's the link to a short 4 minute, informative video going over all the things I mentioned above. It's called "How the FDA expanded it's authority over your body." 

Why would the FDA want such authority? A couple of theories come to mind. Many patients think the main reason has to do with PROFIT. If the cells in our bodies can treat our own diseases or conditions, then the need for pharmaceutical drugs has the potential to become nonexistent. Who will get to profit from adult stem cell treatments? Patients believe this to be a medical procedure between one consenting patient, and their fully capable physician. Risk vs. benefit is very low as your doctor is only treating you with your own cells. Side effects are known to be few, and safety and efficacy are also known to be strong. Here's another article that explains all the things that can be treated with adult stem cells and that those treatments are shown to be safe and effective.



Another theory is the FDA would like to slow down the testing and use of adult stem cells so that a lab created equivalent or a bio-similar product could be used as competition. Everyone has probably taken a generic form of an FDA approved drug, and that's exactly what I'm talking about here. Scientist would like to create a generic equivalent of your adult stem cells so that they could be sold to you at a marked up price. Just like many expensive pharmaceutical drugs today.


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"Stu's Views & MS News" / 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly
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Stem Cell Therapy and Government regulations

Stem Cells and Why The US Government want to regulate them.

For anyone who has a chronic illness and looking at the promise of Stem Cell Therapy as an option.

Ask why the US government wants to regulate the way our (own) Stem Cells are used.
YES!! -> Our very own stem cells!

Jennifer Ziegler and Tracy Thompson share with us their Stem Cell journey and how the FDA shutdown of Cell Tex in Houston impacted their treatment and caused them to flee to another country to continue their treatment.

On StuMS Radio - with MS Unplugged, we interviewed two Jennifer and Tracy.

We discussed the stem cell treatment process they used and what could be happening in the near future.

LISTEN to this Candid (characteristic-often humorous) interview.

CLICK here to be redirected to our Blog Talk Channel

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"Stu's Views & MS News" / 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly

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France Approves Multiple Sclerosis Treatment Based On Cannabis

WHY is the USA so far behind in getting this approved?

Multiple Sclerosis Treatment Based On CannabisFrance 24 reports that the French government’s health ministry has announced its approval for limited use of Sativex, a cannabinoid mouth spray, for treatment of patients suffering from multiple sclerosis (MS). Sativex, developed and manufactured by the British company GW Pharmaceuticals, will be the first marijuana-based medicine to be made available in the country.
France 24 also notes that the drug still has a few more regulatory hurdles to negotiate before it is for sale by prescription. GW Pharmaceuticals says the next step in the regulatory process is to work with the French National Agency of Medicine and Health Products Safety (ANSM) to finalize any country-specific requirements. Following completion of this next step, it is then expected that France will issue a national marketing authorization. Launch timing in France is dependent on completion of subsequent national pricing and reimbursement procedures. Sativex will be commercialized in France by GW’s European partner, Almirall S.A., an international pharmaceutical company headquartered in Barcelona, Spain, that researches, develops, manufactures and commercializes its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.
In October, 2013, GW Pharmaceuticals had announced the successful closing of the European Mutual Recognition Procedure (MRP) in France for Sativex oromucosal spray in the treatment of spasticity due to MS and a resulting recommendation for approval by the French authorities.
“The successful completion of this regulatory process for Sativex in France maintains our positive regulatory track record for Sativex, which is already approved in 22 countries, and provides further endorsement of the important role Sativex can play in meeting a substantial unmet need of people with Multiple Sclerosis,” says GW Pharmaceuticals Chief Executive Officer Justin Gover in a GW release. “We look forward to working with our partners, Almirall, towards the launch of Sativex in this important European country.”
Sativex is approved as a treatment for MS spasticity in 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further 8 European countries, as well as Australia, New Zealand and Kuwait. The US license to Sativex is held by Otsuka Pharmaceutical Co. Ltd. in the United States and to Bayer HealthCare AG in the UK and Canada. GW Pharmaceuticals has signed a deal to have Novartis (makers of Gilenya) market Sativex in parts of Asia, the Middle East, Australia, New Zealand and Africa, so is moving ahead in those markets. .
In 2007 GW and Otsuka Phamaceutical entered into an exclusive agreement for Otsuka to develop and market Sativex in the United States. They received permission from the US regulatory authority and the FDA to directly enter late stage trials in the US. Results were released in March. The randomized, double-blind, placebo controlled study was concluded very encouragingly. Dr. Steven Wright, GW’s R&D director said, “We are very pleased to have successfully completed phase II of studies supporting the efficacy of Sativex in Cancer pain, we are now working closely with Otsuka in preparing to develop phase III development of Sativex in the United States.” The current US development program anticipates two more Phase III trials prior to a subsequent submission of a New Drug Application to the FDA.
In the United States, GW announced in August 2013 that it had opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex for the treatment of MS spasticity. GW expects the U.S. Phase 3 trial to commence in 2014. Sativex is also currently in Phase 3 clinical trials as a treatment for cancer pain. This represents the lead target indication for the product in the US.
Marijuana’s role as a medication is complex and controversial. It was used as a medication in the nineteenth and early twentieth centuries but was outlawed in most western countries in mid twentieth century. In Canada, the federal government has developed a medicinal marijuana program, which allows people who meet certain criteria to possess and use marijuana therapeutically. MS is among the conditions for which a permit can be applied. In some cases, Health Canada authorized medical marijuana grow-ops to provide marijuana to people who hold medical use permits.
Health Canada approval of Sativex on April 19, 2005, made Canada the first county in the world in which the cannabis-based spray is available as a prescribed treatment for MS-related pain. Health Canada approved Sativex with conditions, under its Notice of Compliance with Conditions (NOC/c) policy. This authorization reflects the promising nature of the clinical evidence which must be confirmed with further studies. Products approved under Health Canada’s NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use.
In August 2007, GW also announced the approval (NOC/c) in Canada of Sativex as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.
SOURCE: BIONEWS

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Monday, January 13, 2014

KineMed Announces Agreement With EMD Serono to Identify Protein and Lipid Biomarkers For Multiple Sclerosis

EMERYVILLE, Calif.--(BUSINESS WIRE)--   January 13, 2014
KineMed, Inc. (www.kinemed.com) today announced an agreement with EMD Serono to apply KineMed’s mass spectrometric Dynamic Proteomics and lipids platforms to the discovery of protein and lipid biomarkers for multiple sclerosis.
Myelin breakdown and synthesis is a fundamental process underlying progression and resolution of demyelinating disorders such as multiple sclerosis (MS). Sensitive biomarkers of myelin synthesis are necessary for monitoring the in vivo response to candidate remyelinating agents. KineMed’s proprietary technology platform will be used to discover biomarkers that will allow EMD Serono to track and monitor rates of myelin breakdown and repair in the living brain. The synthesis of several myelin lipids and protein components, including cholesterol, galactocerebroside and phospholipids, as well as major myelin proteins, will be measured during periods of demyelination and remyelination in animal models. These measurements will be made by use of KineMed’s proprietary Dynamic Proteomics and lipid synthesis technologies. This study will also utilize KineMed’s recently developed non-invasive translational marker of brain cholesterol synthesis, which measures synthesis of brain-specific 24-hydroxy-cholesterol in the blood to better understand temporal changes in brain cholesterol synthesis relevant to MS.

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