I intend this blog to be a mixture of my personal experiences with Multiple Sclerosis (MS) and news related to MS. Hopefully, I can shed an optimistic light on MS even though it is difficult to be an optimist living with MS.

Thursday, March 31, 2011

Stem Cell Transplant to Treat MS

This has been somewhat of a hot topic lately.  In fact, I know a woman who has gone through this procedure of wiping out her immune system, just to have her body rebuild it.  That is part of the reason that I have yet to blog about the subject - I was hoping to have more information on her experience before posting.  However, I think I have waited long enough; I want to get the info out there, so here it is.

Excerpts from an article on MedicineNet.com:
Replacing bone marrow with the body's own stem cells may help patients with aggressive forms of multiple sclerosis (MS) go for years without seeing their disease progress, a new study shows.
Researchers in Greece are following a group of 35 patients who received experimental stem cell transplants for multiple sclerosis.
By purposefully wiping out the immune cells in a patient's bone marrow with chemotherapy and then repopulating it with healthy stem cells, researchers hope the body's immune system will stop attacking its own nerves, which eventually become so damaged from MS that they can't properly transmit signals.
That damage can lead to wide-ranging troubles, including problems with vision, speech, weakness, coordination of movement, numbness, and pain.

Following Stem Cell Transplants in MS

An average of 11 years after their transplants, 25% of the patients in Greece have not seen their disease progress, the researchers report.
Among patients with active lesions on MRI scans before their transplants, indicating that they were in an inflammatory phase of the disease, 44% have not progressed.
Only 10% of patients who went into the study without evidence of ongoing inflammation were able to remain disease free.
Two patients died from transplant-related complications.
"Keeping that in mind, our feeling is that stem cell transplants may benefit people with rapidly progressive MS," says study researcher Vasilios Kimiskidis, MD, of Aristotle University of Thessaloniki Medical School, Greece, in a news release.
"This is not a therapy for the general population of people with MS but should be reserved for aggressive cases that are still in the inflammatory phase of the disease," he says.
Based on this report, []it now appears that at least some of that early benefit may not have been related to treatment[].

Best Candidates for Stem Cell Transplants

Stem cells have long been used to treat cancer patients, but they are still considered experimental in autoimmune diseases like multiple sclerosis.  But many believe they offer great hope.  "It's the only therapy to date that has been shown to reverse neurologic deficits," says Richard K. Burt, MD, chief of the division of medicine-immunotherapy for autoimmune diseases at Northwestern University's Feinberg School of Medicine in Chicago. "But you have to get the right group of patients."
In Burt's study, which was published in The Lancet in 2009, 17 out of 21 patients with relapsing-remitting MS improved after stem cell transplants, and none had gotten worse after an average of three years.
Another article, published in the February issue of Multiple Sclerosis Journal, shows that steps taken before the stem cells are transplanted back into the body may have an effect on how well the procedure works.
Before the stem cells can be reintroduced, patients go through a conditioning process with chemotherapy, either alone or in combination with radiation, in an attempt to wipe out their dysfunctional immune systems. That's called a high-intensity conditioning regimen.  But a different kind of conditioning, called intermediate-intensity or "mini" stem cell transplantation, doesn't try to kill off all of the errant immune system.
"There was a tendency for there to be longer progressive-free survival in the studies that used the intermediate-intensity regimens compared to those that used the high-intensity regimens," says James T. Reston, PhD, MPH, a research analyst in the Evidence-Based Practice Center at the ECRI Institute in Plymouth Meeting, Pa., an independent, nonprofit group that reviews evidence for experimental therapies.
Exciting news for those with more aggressive forms of MS!  Sounds very interesting, I can't wait to learn more about this developing treatment.  If anyone reading has gone through this process or knows someone who has, I would love to hear their experiences!!!

Sunday, March 27, 2011

Developing Therapy to Treat Muscle Spasms in MS Patients

It has been a few days since my last post because I have been lazy - sorry!  No other excuses, just pure laziness.  I went to the neurologist on Monday for a check up and everything went well with my exam.  I am still feeling good, I went a little lax on exercising this week, but plan on getting back on track.  I have noticed intermittent numbness in my toes and some tingling in my legs at times, but overall I am doing well!

In, MS news, "Canbex Therapeutics Ltd. (Canbex) announced today that it has received a Translation Award of up to 1.75 million ($2.8 million) from the Wellcome Trust to support development of a therapy for the treatment of the debilitating muscle spasms associated with multiple sclerosis and potentially other disorders."  I don't generally blog about therapies designed to only treat one symptom of MS.  This is, in large part, because I don't have a need for these types of therapies at this time and I am more interested in research and therapies that treat MS as a whole or cure MS.  However, I know more and more people are reading this blog, therefore, I feel obligated to report on any and all news that I encounter.

Excerpts from an article on the NMSS website, states:
The award will facilitate further preclinical development of Canbex’s VSN series of compounds and the progression into clinical trials.  It is anticipated that a Phase I trial of lead compound VSN16R could begin in December 2012.
Preclinical studies have shown that VSN16R treatment reduces muscle spasms in an animal model of MS spasticity, with a far lower burden of side effects than the decades-old compounds that are currently in clinical use.  Even at high doses, animals treated with of VSN16R did not show the limpness and muscle flaccidity, know as the “rag doll effect”, that is a characteristic of existing compounds.
MS is a serious and typically progressive chronic disease for which no satisfactory cure is in sight. Spasticity, characterized by sudden and uncontrollable movements of limb and torso musculature, is among the most painful, damaging and debilitating symptoms of the disease.  It can manifest itself in the form of gait disorders, fatigue, spasms and pain. Spasticity can also occur in other conditions, including bladder dysfunction and spinal cord injury.
Current forms of treatment for spasticity are unsatisfactory, and a drug against spasticity that is well tolerated and effective could make a substantial difference to quality of life for MS patients and potentially many others.
Canbex has been developing its VSN series of compounds with the support of interested investors including Fast Forward LLC, a not for profit organization established by the National Multiple Sclerosis Society, USA, to accelerate the development of treatments for MS.  “Fast Forward’s support has been a uniquely powerful endorsement of our efforts, one which has encouraged other funders and the MS community to engage with us,” Stephane Mery said.
"Fast Forward is very pleased that Canbex has been able to leverage its support and the support of others to secure investment from the Wellcome Trust.  This will enable Canbex to make substantial progress in advancing a potentially promising therapy that could significantly improve the quality of life for people living with MS," said Dr. Timothy Coetzee, Chief Research Officer at the National MS Society.

This sounds very promising for the treatment of muscle spasms.  I have experienced slight muscle spasms, but nothing like what I have been told about them by others who suffer through them.  Hopefully this therapy will be as effective as they anticipate and hopefully it will be available as soon as possible for those who need it.

I hope this information is useful to many of you reading!

Wednesday, March 23, 2011

MS Easier to Diagnose

Two of my recent posts (Parasites Used to Treat MS? and MS Incidence Rate on the Rise?) have discussed the fact that it is my belief that MS has become easier to diagnose with the advancements in technology and our knowledge about MS.

Today, I visited the MSIF website and discovered an article about the changes in MS diagnostic criteria.  The revisions simplify the commonly-used criteria which will lead to faster diagnoses.  The article states:

An international panel of experts chaired by Dr Chris Polman has revised and simplified the 'McDonald Criteria' commonly used to diagnose multiple sclerosis, incorporating new data that should speed the diagnosis without compromising accuracy. The publication in Annals of Neurology of the revised Criteria follows a meeting of the panel held in Dublin, Ireland, in May 2010.

The McDonald Criteria for Diagnosis of MS were originally published in 2001, and were named for the chair of the original panel, the late Professor Ian McDonald, a world leader in MS research and former Chairman of MSIF’s International Medical and Scientific Board (IMSB).

Dr. Polman, also a member of the IMSB, also chaired the panel responsible for the 2005 revisions to the McDonald MS diagnostic criteria.

The McDonald criteria were originally developed using data gathered largely from adult Caucasian European and North American populations.

Since their applicability to other populations has been questioned, the panel also considered how well the McDonald Criteria can be applied to specific populations such as childhood MS, and Asian and Latin American populations.

They concluded that the 2010 Revised Criteria would apply to the majority of these populations, but the paper describes specific situations in which further considerations and tests would be recommended to properly diagnose MS in these groups.
The NMSS also reported on this; their article goes into a little more detail.  Regarding the McDonald Criteria "basics" and the revisions, excerpts from the article state the following:

Diagnosis of MS - The Basics Still Apply: The diagnosis of MS is a partly subjective process, and is best made by an expert who is familiar with the disease and who can interpret imaging and laboratory evidence that can supplement the clinical diagnostic process. The requirement remains that there must be no better explanation than MS for the clinical and laboratory findings – other possible diagnoses must be considered and excluded. (Read more here)
The key to an MS diagnosis has been, and remains, the objective demonstration of dissemination of typical disease signs and symptoms in time and space. The 2010 revisions maintain this requirement, but offer several ways of using imaging to determine dissemination. It remains the case that while the use of paraclinical and laboratory examination can speed an MS diagnosis, a solid diagnosis can be made on clinical grounds alone.
No single test can provide adequate information to support an MS diagnosis. Therefore, supportive and confirmatory paraclinical examinations – including analysis of lesions by MRI, of cerebrospinal fluid (CSF), and sometimes of evoked potentials – are still important in helping to confirm an MS diagnosis.

What Has Changed: There is new emphasis that the McDonald Criteria should only be applied to those who present with a clinically isolated syndrome (CIS) suggestive of MS, or who have symptoms consistent with a central nervous system inflammatory demyelinating disease. The panel also considered how well the Criteria can be applied to specific populations such as childhood MS (pediatric MS) and Asian and Latin American populations. They concluded that the 2010 Revised Criteria would apply to the majority of these populations, but the paper describes specific situations in which further considerations and tests would be recommended to properly diagnose MS in these groups.

In past versions of the McDonald Criteria, guidelines were presented for using MRI to demonstrate dissemination of disease in time and space, based on earlier studies. For the 2010 Revised Criteria, published recommendations from the European MAGNIMS multicenter collaboration have been incorporated (Swanton JK, Rovira A, Tintoré M, et al. Lancet Neurol 2007;6:677-686; Swanton JK Fernando K, Dalton CM, et al. J Neurol Neurosurg Psychiatry 2006;77:830-833.) These indicate that:
  • Dissemination in time can be demonstrated by a new T2 or gadolinium-enhancing lesion on a follow-up MRI, with reference to a baseline scan, regardless of when the baseline MRI was obtained. (Previous versions had specified that the reference scan be performed at least 30 days after the initial clinical event; this is no longer a requirement.)
  • Dissemination in space can be demonstrated with at least one T2 lesion in at least two our of four areas of the central nervous system: periventricular, juxtacortical, infratentorial, or spinal cord. These lesions need not be gadolinium enhanced.
In the case of diagnosing primary-progressive MS, aspects of the previous criteria remain, but the MAGNIMS recommendations for demonstrating dissemination in space were incorporated to harmonize with other 2010 updates. As shown in Table 1, diagnosing primary-progressive MS requires one year of disease progression (determined retrospectively or prospectively), plus at least 2 out of these 3 criteria: dissemination in space in the brain based on at least 1 T2 lesion in periventricular, juxtacortical or infratentorial regions; dissemination in space in the spinal cord based on at least 2 T2 lesions; or positive cerebrospinal fluid (CSF) findings.
While the International Panel has provided revised and simplified criteria for MS diagnosis, recommendations for further testing of the Criteria are made as well, to bolster the scientific evidence supporting the 2010 recommendations.

So, in simplifying the criteria and making an MS diagnosis quicker, is that a good thing or a bad thing?  On the one hand, people diagnosed may be able to get on therapy quicker.  But, on the other hand, does this open us up to misdiagnoses?  That is the question.  Thoughts?  

Saturday, March 19, 2011

Parasites Used to Treat MS?

I found this news article on the NMSS website posted on Friday (3/18/11).  It is about using a parasite to treat MS.  The article states the following:
Two recently published studies are reporting results related to parasitic worms, called helminths, and their possible implications for treating multiple sclerosis. Further study, including the second phase of the reported clinical trial supported by the National MS Society, should determine whether a “probiotic” treatment approach using relatively harmless parasitic worms to alter immune activity will benefit people with MS.
Background: Scientists have noted that autoimmune diseases and allergies are less common in underdeveloped regions. Some researchers have noted that early exposure to common infectious agents – such as that which occurs to people in regions with poor sanitation – may stimulate immune regulation in a positive way and aid healthy immune responses. Because MS is more prevalent in regions with high standards of hygiene, researchers have been testing the “hygiene hypothesis” – the idea that lack of exposure to common innocuous agents at an early age may cause the immune system to over-react and trigger MS.
Studies in MS-like disease in lab rodents and preliminary clinical trials in Crohn’s disease, an autoimmune disease of the bowel, suggest that drinking a concoction containing eggs from parasitic worms might alter immune attacks and improve these conditions.
So far, there are two groups researching this topic; one at the University of Wisconsin and one in Argentina.  At the University of Wisconsin, five people were given a "drink containing harmless helminth eggs."  The findings: "Three out of the five participants had mild gastrointestinal symptoms 30 days after the first dose. These symptoms resolved spontaneously within six days. No worsening in neurological symptoms occurred. The number of participants and study design make it difficult to draw firm conclusions about the treatment’s effectiveness, but beneficial trends were noted in relation to MRI and immune activity. Immunologic analyses indicate that a vigorous immune response was mounted in response to the treatment."  Regarding the study in Argentina, the article states: Doctors "observed 12 people with MS and parasitic infections as a follow up to a study they reported in 2007. In the previous study, they reported observations of 12 people with MS and parasitic infections, and they compared clinical, MRI, and immunologic data with 12 uninfected people with MS. Over four years of observation, the infected individuals showed signs of benefit including lower number of relapses, minimal changes in disability scores, and significantly lower MRI activity compared with uninfected people."

This is really interesting for a few reasons.  First, I find it so interesting that they think MS may be caused, essentially, by being to clean.  In some ways it makes sense; I understand that your immune system needs exposure to various viruses and bacteria in order to build your immune system and develop immune responses to fight these viruses and bacteria.  However, I have always understood MS to be caused by an overactive immune system that begins to attack the central nervous system (CNS) as a foreign invader.  This definition does not lead me to fully understand how introducing more "innocuous agents" would build the immune system up in a way that would prevent it from attacking the CNS.  Second, I am not sure how I feel about introducing parasitic worms into my system to treat my disease.  I suppose if it was 100% (or close to 100%) effective at treating MS and would not cause other problems, then I would consider it, but "drinking a concoction containing eggs from parasitic worms" just does not sound like something that I would really WANT to do.  Finally, I question how accurate their data is that suggests that "autoimmune diseases and allergies are less common in underdeveloped regions."  I would really need to know more about this area of the study.  In my "MS Incidence Rate on the Rise?" post, I questioned whether the rate is truly on the rise or whether it is just now being more frequently and accurately diagnosed due to better technologies.  In this case, I would question the accuracy of their findings because "underdeveloped regions" probably have less advanced technologies and less available health care.  If this is the case, then my guess is that less people are being diagnosed in those areas due to people not seeking medical care and health care providers not being equipped to accurately diagnose MS.  Obviously, I do not know where they are getting their data, but I would definitely be interested in learning more about this ongoing research.     

I am glad research is ongoing, analyzing all possible causes/treatments for MS, even if that research seems very odd to me.  Every little bit counts, even the bizarre.

I would love to know everyone's thoughts on this research.

Friday, March 18, 2011

Random Blogging

This is going to be a somewhat random post of a few different topics that I think are worthy.  :) 

I'd like to take a moment to thank everyone who has read my blog; I have noticed a significant increase in page views and followers lately and I am so happy that people find my blog worthy enough to read!  It means so much to me that people are reading; I just hope that I can provide valuable information to those who are reading.

I also want to thank everyone who participates in Walk MS and Bike MS.  A couple of weeks ago, I discovered that one of my best friends started a Walk MS team in the Chicago area and a number of people that I went to college with have joined the team.  I also learned that another friend from college, who participates in Bike MS, is riding (at least in part) on my behalf this year!  In addition to these amazing people, my parents, husband and friend/roommate from college will be walking with me on April 16th!  It means so much to me that people would contribute their time and efforts to walk on my behalf (I understand that many people walk on behalf of others, but just the idea that people are supporting me is so moving).  I am constantly in awe of every one's support and generosity, it blows me away to know that so many people care.


Update time:  Still feeling pretty good overall.  I played volleyball again this week and had no flare ups!  I did, however, begin noticing some slight numbness in my toes again and I also felt the beginnings of left-hand numbness again.  None of the numbness is back in full force at this time though, so that is good!  I have been exercising more regularly, which is good.  I have noticed, however, that I get tingly and the L'Hermittes acts up when I go on walks (inside, in the basement, and outside, with the dog).  It is strange, these symptoms seem to be worse when we go on walks outside.  I also find it strange that my walking causing symptoms, but playing volleyball does not.  I don't know what to make of this, but none of the symptoms are bad enough to worry too much about right now.  When I do have flare ups during/after walking, they go away after I rest and cool down.  Can't really complain about these minor symptoms.

Recently, I discovered a fellow MS Blogger, who is detailing her experiences on the new oral therapy, Gilenya.  Her story is quite exciting, her condition seems to have improved significantly since starting Gilenya.  Anyone wanting more information about Gilenya or thinking about starting Gilenya should read her blog!  For her account of how Gilenya is helping, go to http://gilenya-girl.blogspot.com/

Wednesday, March 16, 2011

MS Incidence Rate on the Rise?

This week's mailer from the MS International Federation had a report entitled "Increasing frequency of multiple sclerosis in Catania, Sicily: a 30-year survey."  The report stated that (regarding Catania's MS incidence rate), "Overall the authors found that during the last 30 years the incidence of MS in this population increased from 1.3/100,000 during the first 5 years of the study (1975-9) to 7.0/100,000 during the final 5 years (2000-4), suggesting that the incidence of MS is still rising and supporting data from elsewhere."

My question is this: Is the MS incidence rate truly on the rise or are technological advancements simply allowing for more MS diagnoses? 

In 1975, the year this study began, I would argue that less people were diagnosed with MS because technology was not good enough to accurately diagnose a person with MS, except in the most obvious cases.  As we know, MS is generally diagnosed after ruling out all other possible diagnoses.  Maybe in 1975, doctors were just unable to accurately diagnose MS in the way that they can today.  MRI technology has gotten better - allowing us to see more of the brain.  Also, I would argue that MS is better understood today than in 1975, which probably leads to more diagnoses. (clearly, there is still plenty that we are still learning about MS, but certainly we know more now than in prior years).  In addition, some people may have ignored initial symptoms and waited years before going to the doctor and getting a diagnosis.  Maybe people are just more apt to go to the doctor earlier on.  It seems as though there could be a number of possibilities.  

In conclusion, I really don't know how we can be sure that the incidence rate is rising.  Clearly, the number of people diagnosed with MS is rising, but does that truly mean that the incidence rate is on the rise?

Monday, March 14, 2011

MS = Opportunity Amidst Adversity

This week is MS Awareness week and the National MS Society is celebrating by asking what MS equals to you.  You can follow this link to the website and add what MS equals to you. 

I decided that for me MS = Opportunity Amidst Adversity.  The opportunity to educate myself and others as to what MS is and what we can do to work toward a cure.  The opportunity to strive to make the world more aware of MS.  The opportunity to raise funds for research that may one day cure MS.  The opportunity to learn more about myself in the process of learning more about my disease.

Although being diagnosed with MS was unwanted, I have tried to make the most of my diagnosis.  I believe that I can (and will, somehow) change the world and I believe that this diagnosis was God's way of heading me down my path to do just that.  That is why for me MS is about finding every possible opportunity available while afflicted with this adverse situation.

As you may (or may not) know, the Kansas state motto is "Ad Astra Per Aspera" which means "to the stars through difficulty."  I have always loved this Latin phrase and, although, my life has not been extremely difficult in comparison to many people, I believe that all people struggle from time to time in some way.  I have often felt that life is a struggle even though I have MANY great things going in my life.  The thing to remember is that it is how you respond to those struggles and how well you can persevere through that adversity that really matters.  I think we should all strive for the stars even when faced with difficulty.  That is what I have tried to do in response to my diagnosis.  It has not always been easy and I know I complain at times, but I really do believe that I will persevere and, hopefully, I will excel. 

This is why for me, MS =  Opportunity Amidst Adversity.

What does MS mean to you? 

Sunday, March 13, 2011

Good Stuff from UNC

Researchers may have discovered the cause of MS!  Exciting research ongoing at the University of North Carolina may have discovered the cause and a possible way of curing MS.

From an article that my sister emailed to me:

Patients afflicted with multiple sclerosis may soon have the treatment they’ve been waiting for.
In a study published in the Jan. 27 issue of the journal Neuron, University researchers outlined their controversial finding that the reviving of the nodes of Ranvier can prevent the chain reaction that results in MS, a chronic, often disabling disease that attacks the central nervous system.
Led by cell and molecular physiology professor Manzoor Bhat, the study uncovered a molecular mechanism in nerve fibers that is crucial to conducting neural impulses, the messengers that communicate between the brain and the body.
And it defied all of the earlier findings.
“There is a lot of controversy going on over this because the results go against the other studies done on the same topics,” said research associate Courtney Thaxton, the lead author of the study.
The study found that the nodes of Ranvier, which facilitate the neuron’s conduction process, keep myelin segments from overlapping. Thaxton said this is important because if the segments touch they stop the neuron from functioning and cause MS.
Previously, scientists did not fully understand the nodes of Ranvier’s effect on the neuron’s function, she said.
“The important thing is to not let the myelin touch,” Bhat said. “These nodes … do not allow the paranodes to touch.”
The findings could lead to a way for doctors to remake the nodes of Ranvier in patients who are in the early stages of MS. By regrowing the nodes, doctors could prevent the myelin from overlapping and disintegrating, possibly halting the disease.
Thaxton said future studies on the topic will be focused on finding the time it takes for a neuron to be unrecoverable.
“We need to find the point of no return,” she said.
“We need to find how long a neuron can go before there is no hope for remyelination so we can know when to treat the disease.”
In order to continue work on the study, Bhat and Thaxton are also working on attaining grants for the project.
“We are hoping that being published in the journal and getting that attention will help us receive further funding so we can continue research,” Thaxton said.
Glenn Matsushima, a researcher of the brain and its development, said that the results are critical to finding a cure for MS.
“If we can find a way to remyelinate the neuron, we could find a way to reverse the effects of MS,” Bhat said.
“Now that we have this research we are one step closer to finding that.”

So, if we can figure out how to rebuild these nodes and remyelinate the neurons, we could have a cure for MS.  Very interesting and exciting if this holds water!  I would love to know more about this; I tried to find more on this subject but was not very lucky.  If anyone has any additional information regarding this, please let me know!

Wednesday, March 9, 2011

Update on Me & MS Awareness Week

It has been awhile since I have posted anything about how I am doing (the "my experiences with MS" portion of the blog).  So, I thought I would post a quick update.

Overall, I have been feeling pretty good lately (which is, in large part, why I haven't posted about my condition).  I am still experiencing some numbness in my toes/feet, but I barely notice it (so I am either used to it or it is very slight).  I have been trying to be better about working out and utilizing our unfinished basement for this.  Monday, I did a few exercises and ended up feeling very tingly, but the sensation subsided once I had cooled down.  Also, the L'Hermittes flared up during/after the "workout," but I did not notice any symptoms at all on Tuesday. 

I mentioned earlier that I played volleyball for the first time since my diagnosis a couple Sundays ago and it went well overall.  I did notice some worsened symptoms toward the end, but I think I was able to stay cool enough that it didn't get bad.  Yesterday, I played volleyball a second time and cannot say that I noticed any "flare-ups" at all during or after playing!!!  I am going to start playing regularly on a league in town and am hopeful that I can continue to play without experiencing any significant symptoms.

My husband and I tried out the Yoga for MS dvd the other weekend and, although I was sore the next day, I am not a huge fan of yoga.  I don't really get into the "spiritual," meditation aspect and I don't really understand all of the breathing techniques.  I know many people really like yoga and most people say great things about it, but it just isn't my style. 

I took tonight off, but plan to do some sort of exercise 4 to 5 times per week.  I was pretty sore after my "workout" on Monday and realized that I am, apparently, VERY out of shape!  So I will continue exercising in the basement and trying to do yoga. 

So that is the news with me - mostly good stuff going on.  Can't complain too much! 

On another note, next week (March 14 - 20) is MS Awareness Week and the National MS Society is currently promoting its MS = campaign.  Check it out and consider participating in the campaign to spread awareness.  Use your social media outlets, such as facebook and twitter, to tell people what MS means to you.

Tuesday, March 8, 2011

Low Dose Naltrexone & Second-Hand Smoke

There is ongoing research regarding the benefits of low dose naltrexone (LDN) in MS patients.  Naltrexone was originally approved by the FDA (in 1984) for the purpose of helping heroin or opium addicts.  It did this by blocking the effect of the drugs. "By blocking opioid receptors, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce: beta-endorphin and metenkephalin. Many body tissues have receptors for these endorphins and enkephalins, including virtually every cell of the body's immune system."  Subsequently, in 1985, a physician discovered the effects of a much smaller dose of naltrexone on the body's immune system. "He found that this low dose, taken at bedtime, was able to enhance a patient's response to infection by HIV, the virus that causes AIDS."  The phycisian learned in the 1990s that cancer patients and patients with autoimmune diseases could also benefit from LDN. 

Information from http://www.lowdosenaltrexone.org/:
Up to the present time, the question of "What controls the immune system?" has not been present in the curricula of medical colleges and the issue has not formed a part of the received wisdom of practicing physicians. Nonetheless, a body of research over the past two decades has pointed repeatedly to one's own endorphin secretions (our internal opioids) as playing the central role in the beneficial orchestration of the immune system, and recognition of the facts is growing.
The brief blockade of opioid receptors between 2 a.m. and 4 a.m. that is caused by taking LDN at bedtime each night is believed to produce a prolonged up-regulation of vital elements of the immune system by causing an increase in endorphin and enkephalin production. Normal volunteers who have taken LDN in this fashion have been found to have much higher levels of beta-endorphins circulating in their blood in the following days.
In general, in people with diseases that are partially or largely triggered by a deficiency of endorphins (including cancer and autoimmune diseases), or are accelerated by a deficiency of endorphins (such as HIV/AIDS), restoration of the body's normal production of endorphins is the major therapeutic action of LDN.
Regarding its efficacy in patients with autoimmune diseases, including MS, the website states, "Within the group of patients who presented with an autoimmune disease, none have failed to respond to LDN; all have experienced a halt in progression of their illness. In many patients there was a marked remission in signs and symptoms of the disease. The greatest number of patients within the autoimmune group are people with multiple sclerosis, of whom there were some 400 [patients]. Less than 1% of these patients has ever experienced a fresh attack of MS while they maintained their regular LDN nightly therapy."

Regarding the question of when LDN will be FDA Approved, the website says:
The FDA approved naltrexone at the 50mg dosage in 1984. LDN (in the 3mg or 4.5mg dosage) has not yet been submitted for approval because the prospective clinical trials that are required for FDA approval need to be funded at the cost of many millions of dollars.
The successful results of the first US medical center research on LDN, an open-label trial that tested the use of LDN in Crohn’s disease, was presented in May 2006 by Professor Jill Smith of the Pennsylvania State University College of Medicine. The National Institutes of Health has granted $500,000 for Dr. Smith's group to continue the study as a larger placebo-controlled scientific trial of LDN in Crohn's disease.
All physicians understand that appropriate off-label use of an already FDA-approved medication such as naltrexone is perfectly ethical and legal. Because naltrexone itself has already passed animal toxicity studies, one could expect that once testing is able to begin, LDN could complete its clinical trials in humans and receive FDA approval for one or more uses within two to four years.
Note: It appears as though this website is up to date (at least as of December 2010).

I received an email regarding LDN in a mailer sent out by the Multiple Sclerosis International Federation.  The email, discussing research published last month, said:
The use of low dose naltrexone (LDN) in patients with MS in clinical practice is controversial. This study examined the long term effects of the opioid growth factor (OGF, [Met5]-enkephalin) and LDN on expression of myelin oligodendrocyte glycoprotein (MOG)-induced [experimental autoimmune encephalomyelitis] (EAE). The results indicate that treatment with LDN and OGF had no deleterious long-term repercussions and did not exacerbate EAE, but i) halted progression of disease, ii) reversed neurological deficits, and iii) prevented the onset of neurological dysfunction across a considerable span of time.
That may not make a whole lot of sense, but I think the important take-away is that no harmful, long-term, side-effects of LDN were noted, but results showed that LDN halted the progression of the MS disease, reversed neurological deficits, and prevented the onset of additional neurological dysfunction.

I think we should really be looking into this more!  It sounds like it is a promising option for treating MS, but has not gained enough notoriety and funding to get FDA approval.

Another area of research that was discussed in the mailer from the Multiple Sclerosis International Federation was regarding second-hand smoke and its association with an increased risk of developing MS.  The mailer stated:
Exposure to environmental tobacco smoke is associated with increased risk for MS:
This interesting population-based case-control study reports the incidence of passive smoking in patients with MS and controls who had never smoked. Through comparison of rates of the incidence of multiple sclerosis among never-smokers who had been exposed to passive smoking and comparison with that of never-smokers who had never been exposed, an odds ratio was calculated of 1.3 (95% CI 1.1-1.6). The authors also found that the risk increased with increasing duration of exposure to passive smoke.
The authors conclude that passive smoking is associated with an increased risk of developing MS, and that the underlying mechanism may relate to irritation within the lung, as oral tobacco in the form of moist snuff is not associated with increased risk.
The increased risk of developing MS by smoking was discussed in the 2/14/11 Teleconference.  I didn't pay too munch attention to it, however, because I have never smoked so it clearly didn't apply to me.  However, this study seems to show that ANY exposure to cigarette smoke is associated with an increased risk of developing MS.  This is disturbing, considering most public places, including restaurants had "smoking sections" (where you, in the non-smoking section, could still smell the smoke) until very recently.  I am sure there are still places that allow smoking in public places, but luckily many towns/cities across the country have banned smoking in bars and restaurants.  I was rarely exposed to smoke as a child, but I do recall being at restaurants, in the "non-smoking section" and being bothered by the smoke wafting in from the "smoking section."  As I grew older, I was exposed to smoke a little more although I tended to avoid it at all costs.  I cannot say that I believe that second-hand smoke was a major contributing factor to me developing MS, but, according to this study, it could have played a small role.  So the lesson to be learned is that smoking is bad, whether you are the smoker or just around smokers.  I know this is not new, earth-shattering news, but it is one more way we know that smoking is bad.

Sunday, March 6, 2011

Cladribine Denied FDA Approval & More Ways to Get Involved

From an article on Multiple Sclerosis Association of America's website:
EMD Serono, Inc., makers of Cladribine Tablets (an oral formulation of cladribine), announced today that they received a complete response letter (CRL) from the United States Food and Drug Administration (FDA). The FDA issues a CRL when it has completed the review of an application. However, in this situation, the FDA was not able to approve the application without additional information. The announcement was disappointing to members of the MS community, who were hoping to see another option added to the list of available disease-modifying therapies for the long-term treatment of MS.
According to EMD Serono, the FDA found substantial evidence of Cladribine Tablets' effectiveness as indicated by the CLARITY study. While the effectiveness was not in question, the FDA is looking for an improved understanding of safety risks and the overall benefit-risk profile. This will require either additional analysis of presently available data, or additional studies to be conducted.
The drug company plans to request an end-of-review meeting with the FDA. During such a meeting, EMD Serono would find out how to proceed and if data from completed and ongoing clinical studies with Cladribine Tablets could be sufficient to answer the FDA's questions about safety.
EMD Serono notes that they remain committed to completing their ongoing studies with Cladribine Tablets and to continue to seek FDA approval of their drug. Three ongoing studies are nearing completion, and top-line results (the initial, primary outcomes of a study) are expected by the end of 2011 and in the first half of 2012. The safety data from these studies should provide valuable, additional safety data for the FDA to consider.
Cladribine is an investigational oral drug being studied for the long-term treatment of relapsing forms of multiple sclerosis (MS). It was submitted to the United States Food and Drug Administration (FDA) for approval and received Fast Track status in July 2010. Fast Track status reduces the FDA's review time from 10 months down to six - and a decision was expected by November 28, 2010. However, the agency extended the review time by three months, with a decision anticipated by February 28, 2011.
While Cladribine Tablets were approved earlier this year in Australia and Russia (under the trade name Movectroi®), European regulators issued a negative opinion in regard to whether the benefits outweigh the risks. Merck Serono (a division of Merck KGaA) plans to appeal this negative decision, which came from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. This rejection was issued in September 2010, prior to the FDA extending its review period of the drug. 

It would have been nice to have another oral therapy available, but if the risks outweigh the benefits then it is better that we wait for more testing to be done.

More Ways to Get Involved:

1.  PUREWATER2GO, maker of fine filtered water bottles, has chosen to honor MSWorld during the month of March, MS Awareness Month!  This company shares the essence of MSWorld in their desire to improve quality of life.  For more information about this offer, click here.

2.  Register for MSAA’s webinar “MS on the Fast Track: The 411" and have your questions about MS answered by Mark Tullman, MD, Assistant Professor of Neurology and Director of the Columbia University MS Clinical Care Center.  Click here to register!

3.  Swim for MS is one way to help raise funds and awareness – any pool, any time. See what some of the swimmers have been up to by visiting the MSAA Swim for MS website.

Saturday, March 5, 2011

Brain Damage and Teleconferences

A new study, published in Brain, suggests that damage to the locus coeruleus (an area of the brain) may be associated with MS.  Apparently, damage to the locus coeruleus (LC) results in a decrease in noradrenaline (the neurotransmitter involved in responsiveness and fear) production, which can result in inflammation similar to that seen in MS patients. 

From an article on dailyrx.com
Decreases in noradrenaline, the neurotransmitter involved in responsiveness and fear, has been well documented in cases of Alzheimer's disease and Parkinson's disease, but this study marks the first time the hormone has been linked to MS. Noradrenaline also acts as an immunosuppressant in the brain, safeguarding against inflammation and stress to neurons while also preserving the integrity of the blood-brain barrier.
Researchers discovered damage to the locus coeruleus (a part of the brain stem involved with physiological responses to stress and panic) and reduced levels of noradrenaline in a mouse model of MS and similar changes in the brains of MS patients.
Paul Polak, research specialist in the health sciences in anesthesiology at the University of Illinois at Chicago and lead author of the study, said drugs designed to increase noradrenaline in the brain may serve as a therapeutic intervention for multiple sclerosis patients based on the study, which suggests locus coeruleus damage may be a common feature of neurological diseases.

The Multiple Sclerosis Foundation recently sponsored a teleconference entitled "Emerging Therapies" featuring speaker Dr. Aaron Boster, Assistant Clinical Professor of Neurology, Ohio State University.  I was able to listen in on Wednesday evening and, although, Dr. Boster did not discuss any therapies that differed from those discussed during the 2/14/11 teleconference that I have previously blogged about, Dr. Boster sounded very knowledgeable and I would really like to have the chance to hear him speak again.  Dr. Boster fielded questions for about 30 minutes and I was disappointed that I did not get to ask a question (I apparently, accidentally and unknowingly, cancelled my question out).  He did not discuss CCSVI, Estriol, or Vitamin D, but I really would have liked to have heard his views/opinion on these topics.  Hopefully, I will get another chance to hear Dr. Boster speak and field questions.

The MS Foundation will be sponsoring another teleconference later this month, for anyone interested, here is the information:  The name of the teleconference is Strategies to Improve Walking, Balance, Strength, and Flexibility with Herbert Karpatkin, PT, DSc, NCS, MSCS.  You can catch it on Monday, March 21st from 8:00 p.m. – 9:00 p.m. EST or Tuesday, March 22nd from 7:00 p.m. – 8:00 p.m. PST.  To attend the teleconference(s), call up to 10 minutes before the starting time: 888-550-5602, and enter 2344 1168. 

I am not sure yet whether I will be tuning into this teleconference, but if I do, I will be sure to report back on what I learn.

Friday, March 4, 2011

Future Therapies: The Finale (Tovaxin & Apitope Vaccines)

Tovaxin, by Opexa Therapeutics, is a cellular immunotherapy that has completed a Phase IIb clinical study for the treatment of MS.  It is a personalized T-cell vaccine for the treatment of multiple sclerosis (MS) that is specifically tailored to each patient's disease profile and is designed to reduce the number of specific subsets of autoreactive T-cells known to attack myelin.  It helps limit attacks by T-cells on myelin, the protein sheath that protects nerves.

Excerpts From Opexa Therapeutics' website:
Tovaxin is being developed as a first line treatment for MS. The treatment will consist of donating blood and creating a vaccine using the patient’s own cells. The vaccine cells will be irradiated to render them unable to divide, but able to evoke an immune response. The vaccines will be administered in the doctor’s office as a subcutaneous injection in the arm given five times a year. The first four injections are administered a month apart with the fifth and final injection being administered two months after the fourth. While many other MS treatments have constant side effects such as flu symptoms, injection site problems, and serious adverse events, Tovaxin has not had any treatment related serious adverse events (SAEs). The most common side effect reported form clinical studies has been mild to moderate injection site reaction that usually resolves without treatment within 24 hours. Tovaxin therapy is specific for the immune response against myelin destroying T cells and does not cause a general immunosuppression. Tovaxin may be a strong alternative for subjects who do not want to start hospital infusions or weekly injections, or have not been able to tolerate the side effects or infections of immunosuppressant drugs on the market.
Tovaxin treatment selectively targets and depletes the pathogenic T-cell population. It is not a general immune suppressant and accordingly, is not associated with the serious side effects seen by those MS treatments that function by systemically suppressing the immune system. In clinical trials conducted to date, including the 150-patient Phase 2b study, there have been no serious adverse events associated with Tovaxin treatment.
Phase IIb results:  Data from the 12-month analysis of the Phase IIb TERMS study demonstrated a number of positive outcomes. Recently announced data in patients with at least one relapse in the 12 months prior to study entry showed:
  1. More than 83% of Tovaxin-treated patients remained relapse free at one year
  2. 42% decrease in annual relapse rate (ARR) following treatment compared to placebo
  3. 73% of Tovaxin-treated patients showed stabilization or improvement in MS disability including 16.5% with a sustained improvement in the Expanded Disability Status Scale (EDSS) of at least one full point.
All analyses of the TERMS study data have shown Tovaxin to be safe and well tolerated with no serious adverse events related to Tovaxin treatment. Mild injection site reaction was the most common adverse event.
This about.com article helps to better explain the process in layman's terms.  From the article:
MS is caused when certain immune cells attack the myelin in the central nervous system. These immune cells are called myelin-reactive T-cells (MRTCs). Everyone has them, but in people with MS, they become “active” and “pathogenic” (which simply means they are causing disease). No one knows why they “turn on” in this way in certain people – it is probably a combination of factors, including genetics, infections, vitamin D exposure and metabolism, etc. The fact remains that when these MRTCs get going, they cause MS. That means that the ideal way to treat MS would be to stop these MRTCs from doing their bad work.
Tovaxin is an attempt to do more than stop these MRTCs – it actually is designed to eliminate the exact T-cells that are doing the damage from our bodies, without affecting the rest of the immune system. How does it do this?
1) First, the Vaccine is Manufactured
The vaccine is made from each person’s MRTCs. That’s right – blood is taken from each person with MS, the MRTCs are isolated, multiplied to large quantities and attenuated (which means they are weakened so as not to pose a threat).
2) Next, It is Injected Into the Patient
The vaccine, containing 30 to 45 million of these attenuated MRTCs is put back into the patient, using a simple subcutaneous injection.
3) The Body Responds
The body recognizes these MRTCs as invaders, both because they are damaged and because there are so many of them. The immune system attacks these MRTCs, but more importantly, it attacks all of the circulating MRTCs (the ones that are still alive doing damage). Ultimately the MRTCs are eliminated by other T-cells. These T-cells are produced by memory white blood cells (memory WBCs), which will keep producing them as long as any MRTCs are detected.
This has two effects: 1) Controls and gets rid of MRTCs, and 2) Rebalances the whole immune system so that it is no longer in “inflammation” mode. The second point is important, because in a person with relapsing forms of MS, it is not just MRTCs that cause damage – an army of other immune cells that are signaled by the activity of the MRTCs also contribute to the creation of lesions, which in turn cause the symptoms of MS.
Opexa has met with the FDA and hopes to begin Phase III trials very soon.  Sounds like the vaccine approach could work and be a very viable option in the future!

From an Apitope news release:
Apitope, the European biotech company developing therapeutic peptides to treat autoimmune and allergic diseases, announced the start of its second Phase I clinical trial of ATX-MS-1467, in patients with Multiple Sclerosis (MS).
ATX-MS-1467, an investigational peptide-based therapeutic derived from Apitope’s proprietary technology platform, has already completed successfully a Phase I clinical trial in six patients with secondary progressive MS (SPMS). This new Phase I study aims to build on the results from the initial study and investigates safety and proof-of-principle of ATX-MS-1467 in 40 patients with relapsing forms of MS (RMS).
Apitope is developing ATX-MS-1467 with Merck Serono, one of the leading pharmaceutical companies in the treatment of MS. Under the terms of the agreement between the two companies, Apitope is responsible for all Phase I development of ATX-MS-1467. Merck Serono will take over development of the compound at the beginning of Phase II clinical trials.
ATX-MS-1467 consists of four synthetic peptides that mimic naturally occurring peptides derived from human Myelin Basic Protein (MBP), a key autoantigen in multiple sclerosis. ATX-MS-1467 has been designed from naturally occurring MBP fragments and is intended to selectively inhibit the immune system's harmful attack on the protective myelin sheath surrounding the nervous cells while preserving the normal immune response to any harmful antigens, such as infections.
Unfortunately, there was not a whole lot of information available about ATX-MS-1467 because it is still so early on in clinical trials, but I look forward to hearing more about it and sharing that information with you.
This post wraps up the "Future Therapies" portion of the Teleconference information.

In other news, a fellow MSer, who has been blogging about his experiences and knowledge of therapies for some time had a great post recently.  He had the CCSVI procedure and has blogged a number of times about CCSVI.  His recent post primarily discusses the views and ongoing debates regarding CCSVI.  If you'd like to read his post, click here.

Also, I recently became a member of WEGO Health, a website for "health activists."  I am very excited to be a member of many of the groups, including the Multiple Sclerosis group!

Tuesday, March 1, 2011

March is MS Awareness Month

March is the month to try to really get the word out, so I will do my best to post often this month. 

Thank you to all of those who have contributed to my fundraising efforts for Walk MS!  For more information, feel free to visit my personal page.

Also, thank you to my friends in the Chicago area for putting together a Walk MS team on my behalf!  For information on their team, visit their team site!

Thank you to all who have been reading this blog!  My next post will discuss information about the use of Tovaxin and Apitope Vaccines as MS therapies.  Please keep reading!!!