Hello, Again

I know it has been awhile, but there is a reason, I promise!  Mostly exhaustion!  I am pregnant and off my meds so I have pregnancy exhaustion plus MS fatigue.  Overall, however, I have been feeling great!  I have to go to bed earlier, but I, luckily, bypassed most of the early-pregnancy nausea and my MS flare-ups have been minor and few and far between.  I feel very blessed!  I am 19 weeks along now and my husband and I couldn't be more excited to welcome our baby boy to this world sometime around the end of July!  I feel like all I do lately is eat, sleep and work, but it is good! 

We've had a lot going on at the society lately too - we had a booth set up at our local Women's Fair in February, which I worked.  We lost an amazing staff member, which was really sad, but we all understood her reasons for leaving and we wish her the best!  Our Walk MS event is less than a month away - March 31st!  So I have that going on as well.  If you are interested in donating, visit my personal page!  I have a fairly lofty goal this year and am starting to worry that I won't reach it.  I have 5 other team members - my faithful husband, my loving parents, and two great co-workers!  I am hoping that I can rope a few more people into participating, but we'll see. 

And now, MS news from my most recent MSF email:

BG-12 New Drug Application Submitted

Biogen has announced it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for marketing approval of BG-12 (dimethyl fumarate), an investigational oral therapy in late-stage clinical development for the treatment of relapsing-remitting MS. The regulatory submission was based on research in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability – the Phase 3 DEFINE and CONFIRM studies.

In 2011, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled phase III clinical trials that evaluated 240 mg of BG-12, administered either twice a day or three times a day, for two years.
Biogen Idec says there are also plans to submit a Marketing Authorisation Application for BG-12 to the European Medicines Agency (EMA) within the coming days.

“The rapid submissions of our BG-12 regulatory packages, which integrated one of the largest placebo-controlled data sets for a filing in MS, reflect our commitment to bringing additional therapies to patients in need as quickly as possible,” says Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “We anticipate hearing from regulatory authorities regarding the status and acceptance of our submissions within the next couple of months.”

 

 

Scientists Dismiss One Hypothesis on How MS Develops
One current hypothesis on how MS develops has recently been refuted by neuroimmunologists who studied myelin damage that was created in a new mouse model of the disease. They concluded that the death of oligodendrocytes (the cells that produce the myelin sheath) does not trigger MS.
With their research, the scientists say they have disproved the so-called "neurodegenerative hypothesis." This was based on their observations that certain patients exhibited characteristic myelin damage without a discernable immune attack. In their new hypothesis, the scientists assume that MS-triggering myelin damage occurs without the involvement of the immune system. In this scenario, the immune response against myelin would be the result – and not the cause – of this pathogenic process.
Using genetic tricks, the scientists induced myelin defects without alerting the immune defense. "At the beginning of our study, we found myelin damage that strongly resembled the previous observations in MS patients," explains Burkhard Becher, a professor at the University of Zurich. "However, not once were we able to observe an MS-like autoimmune disease."
To ascertain whether an active immune defense causes the disease based on a combination of an infection and myelin damage, the researchers conducted a variety of further experiments – without success. "We were unable to detect an MS-like disease – no matter how intensely we stimulated the immune system," says Ari Waisman, a professor from the University Medical Center Mainz. "We therefore consider the neurodegenerative hypothesis obsolete."
The teams involved in the study want to continue researching the cause and origins of MS. "In light of these and other new findings, research on the pathogenesis of MS is bound to concentrate less on the brain and more on the immune system in future," says Professor Thorsten Buch from the Technischen Universität München.

Thanks for reading!  

Happy Veteran's Day + BG-12 Update

First, I want to thank the veterans for their service and dedication to our country, our safety, and our freedom!  

With that said, I attended an MS dinner/presentation last night about Stress and MS.  I cannot say that I really learned anything new, but it was a good reminder to keep stressors in check and to be sure to have a good coping system.  Life is stressful, MS adds extra stress, and we need to be able to have coping mechanisms in place to minimize the affects of stress.

Now for the BG-12 update (from the NMSS website):

Biogen Idec announced that the experimental oral therapy BG-12 significantly reduced the average number of annual MS relapses in a two-year, Phase III clinical trial of more than 1400 people with relapsing-remitting MS. Although its exact mode of action is not known, BG-12 is thought to inhibit immune cells and molecules involved in MS attacks on the brain and spinal cord. The results of the CONFIRM study were announced in an October 26 press release. Data analysis is ongoing and the company expects to provide a full report at an upcoming medical meeting. Positive results from another Phase 3 trial of BG-12 were also announced this year, paving the way for a potential application for marketing approval.

Background: Multiple sclerosis involves immune system attacks against brain and spinal cord tissues. Although its exact mechanism of action is not known, BG-12, an oral drug, is thought to inhibit immune cells and molecules and may be protective against damage to the brain and spinal cord. In an earlier phase II study, compared to inactive placebo, the highest tested BG-12 dose led to a 69% reduction in gadolinium-enhanced (a contrast agent) disease activity on MRI scans from weeks 12 to 24. Earlier in 2011, Biogen Idec announced positive results in another phase III study, the DEFINE trial. Further details on these results were presented at the joint meeting of the European and Americas Committee for Treatment and Research in MS (ECTRIMS/ACTRIMS) last week.

This Study: The primary goal of the CONFIRM study was to determine whether BG-12 could reduce the average annual MS relapse rate at two years. Secondary objectives included assessing BG-12’s effects on the proportion of people who had relapses, disability progression, and disease activity detected by MRI. Safety and tolerability were also assessed.
Participants were randomly assigned to one of two treatment groups receiving different oral doses (240 mg twice each day and 240 mg three times each day), a group receiving glatiramer acetate (Copaxone®, Teva Pharmaceutical Industries, an approved, injected therapy for MS) or a group receiving placebo. Both BG-12 groups and Copaxone were compared to the placebo groups, but not to each other.

According to the press release, in both groups taking BG-12, the primary endpoint was met; the average number of MS relapses in a year was reduced by 44% versus placebo in the lower-dose group, 51% in the higher-dose group, and 29% in the Copaxone group. Disease activity on MRI and the proportion of patients experiencing relapses also were reduced significantly more in the BG-12 groups versus placebo. Disability progression was not reduced significantly more in the BG-12 groups than in the placebo group. According to the press release, the most common adverse events in the BG-12 groups were flushing and gastrointestinal events.

Comment: Full details and evaluation of this study should help to define further the safety and promise of BG-12 as a potential therapy for relapsing MS. According to the company press release, these positive results set the stage for upcoming filings for marketing approval from drug regulatory agencies.

It is so exciting to learn that another oral therapy is doing well!  Hopefully soon, injections will be a thing of the past for all of us.  In the meantime, stick with what works.

New News from MSF

In this post: How cool would it be if MS could be diagnosed just by exhaling, BG-12 is showing progress, and odd hours may be a increase the risk of MS in teens, and should we be discussing walking problems with our doctors more?

The following is from my most recent email from the Multiple Sclerosis Foundation.

Diagnosing MS from Exhaled Breath

Scientists are reporting the development and successful tests in humans of a sensor array that can diagnose MS from exhaled breath, an advance that they describe as a landmark in the long search for a fast, inexpensive, and noninvasive test for MS. Their report appears in the journal ACS Chemical Neuroscience.

Hossam Haick and colleagues report have identified volatile organic compounds that can be associated with MS from exhaled breath. Based on these findings, the researchers developed a new sensor array that can diagnose MS by analyzing the determined chemical compounds that appear in the breath of people with MS. Using the developed sensors, the researchers carried out a proof-of-concept clinical study on 34 people with MS and 17 healthy volunteers and found that the developed sensors are just as accurate as a spinal tap but without the pain or the risk of side effects. 

"The results presented here open new frontiers in the development of fast, noninvasive, and inexpensive medical diagnosis tools for detection of chronic neurological diseases," the scientists stated. "The results could serve as a launching pad for the discrimination between different subphases of stages of multiple sclerosis as well as for the identification of multiple sclerosis patients who would respond well to immunotherapy." 

A large clinical study with the sensors is underway and will be reported in the future. Haick is a Professor in the Department of Chemical Engineering and the Russell Berrie Nanotechnology Institute at the Technion – Israel Institute of Technology. 

BG-12 Moves Forward with Positive Data from Late-Stage Trials
Positive top-line results have been reported from CONFIRM, the second of two pivotal phase III clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered twice a day (BID) or three times a day (TID), demonstrated significant efficacy and favorable safety and tolerability profiles. Further analyses of the CONFIRM study are ongoing, and Biogen Idec, the company developing BG-12, anticipates presenting detailed data at a future medical meeting.

BG-12 met the CONFIRM study's primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent for BID and by 51 percent for TID versus placebo at two years. The CONFIRM study's reference comparator, glatiramer acetate (GA; 20 mg subcutaneous daily injection), reduced the ARR by 29 percent compared with placebo at two years. 

Initial results showed that BG-12 reduced 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 21 percent for BID and 24 percent for TID at two years compared to placebo, and GA reduced confirmed disability progression by 7 percent. 

"We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients," said Doug Williams, Ph.D., Biogen Idec's Executive Vice President of Research and Development. "We are gratified by these strong efficacy and safety results, which, when combined with BG-12's oral route of administration, position it as a potentially important MS therapy. We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible." 

In CONFIRM, both dose regimens of BG-12 showed favorable safety and tolerability profiles, which were similar to those seen in the previous late-stage study known as DEFINE. Overall, the incidence of adverse events (AEs), serious adverse events (SAEs) including serious infections, and discontinuations due to AEs were similar across all study groups, including placebo. The incidence of hepatic and renal events was also comparable among all study groups. The most common AEs in the BG-12 groups were flushing and GI events. There were no malignancies in the BG-12 groups. 

Biogen Idec presented data from DEFINE, at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in October 2011.

 

Working Overnight or Odd Shifts May Increase MS Risk in Teens

Working overnight or odd shifts may increase teenagers' risk of developing MS, according to the results of an observational study. 

Researchers from Sweden who uncovered the link said interruption of circadian rhythms and disruption of normal sleep patterns may be partially responsible for the added risk.

In conducting the study, published in the Oct. 18th issue of Annals of Neurology, researchers examined two population-based studies of Swedish residents aged 16 to 70 (one with incident cases and one with prevalent cases) to compare the number of cases of MS among those who did and did not work overnight or shift hours on a regular or alternating basis during their teens.

Among the incident cases, the investigators found those who worked overnight hours for three years or more before the age of 20 were twice as likely to develop multiple sclerosis as those who never worked night shifts. Among the prevalent cases, they noted, the teens who worked overnight hours were slightly more than twice as likely to develop the disorder.

"Our analysis revealed a significant association between working shift at a young age and occurrence of MS," Dr. Anna Karin Hedstrom, of the Karolinska Institute in Stockholm, said in a journal news release. "Given the association was observed in two independent studies strongly supports a true relationship between shift work and disease risk." 

The researchers explained the sleep restriction associated with working the night shift has already been shown to increase the risk for certain health problems, including heart disease, thyroid disorders and cancer, likely by interfering with melatonin secretion and increasing inflammatory responses. 

The authors pointed out that since MS is a central nervous system autoimmune inflammatory disorder that is linked to a person's environment, other lifestyle risk factors, such as sleep loss due to shift work, should also be considered.

The study authors noted that more research is needed to explain why the disruption of circadian rhythm and sleep loss increase teenagers' risk for developing MS.

 

MS Walking Problems Rarely Discussed

Most people with MS who have difficulty walking say it is the most challenging part of the debilitating disease, U.S. researchers say. However, a survey by Harris Interactive indicated 40 percent of people with MS rarely or never discuss walking problems with their doctor. 

The recent survey of more than 1,200 adults living with MS indicated 65 percent reported having trouble walking, the inability to walk, or difficulty maintaining balance at least twice per week. Seventy percent of those with walking issues say that's the toughest symptom to deal with.

In addition, a majority of people living with MS reported they experienced walking problems within the first few years after diagnosis, while among people diagnosed with MS within the past five years, 58 percent reported experiencing a mobility issue at least twice a week.

On average, people with MS ages 41 or younger who do discuss trouble walking with their doctor initiate the conversation only 46 percent of the time. An estimated 78 percent of these women and 62 percent of these men report that trouble walking makes getting around dangerous, the survey indicated.

In light of the increasing menu of therapeutic options, assistive technology, and medication to aid walking problems, conversations with your doctor may lead to solutions.

 

As always, the ongoing studies and research is much appreciated!  Being able to diagnose MS with just a breath is incredible!  Disruption of normal sleep habits increasing the risk of MS makes me reevaluate my sleeping habits and makes me think back to my teenage sleep patterns (probably not the best, but what teenager truly has good sleeping habits?).  I am always happy to hear that clinical trials are going well for up and coming therapies!  Go BG-12!  

Thanks for reading!  Hope everyone is well!

Last Post about Recent MSF Mailer

Ok, so this will be the last (but not least) installment of the recap of the recent MSF mailer I received.  First, mono + vitamin D deficiency may = MS:

New research suggests that people who are exposed to low levels of sunlight coupled with a history of having a common virus known as mononucleosis may be at greater odds of developing MS than those without the virus.
"MS is more common at higher latitudes, farther away from the equator," said George C. Ebers, M.D., with the University of Oxford in the United Kingdom and a member of the American Academy of Neurology. "Since the disease has been linked to environmental factors such as low levels of sun exposure and a history of infectious mononucleosis, we wanted to see whether the two together would help explain the variance in the disease across the United Kingdom."
Infectious mononucleosis is a disease caused by the Epstein-Barr virus, which is a Herpes virus that is extremely common but causes no symptoms in most people. However, when a person contracts the virus as a teenager or adult, it often leads to infectious mononucleosis.
The body makes vitamin D when exposed to ultraviolet B (UVB) light.
For the study, researchers looked at all hospital admissions to National Health Service hospitals in England over seven years. Specifically, they identified 56,681 cases of MS and 14,621 cases of infectious mononucleosis. Scientists also looked at NASA data on ultraviolet intensity in England.
The study found that adding the effects of sunlight exposure and mononucleosis together explained 72 percent of the variance in the occurrence of MS across the United Kingdom. Sunlight exposure alone accounted for 61 percent of the variance.
"It's possible that vitamin D deficiency may lead to an abnormal response to the Epstein-Barr virus," Ebers said.
He noted that low sunlight exposure in the spring was most strongly associated with MS risk.
"Lower levels of UVB in the spring season correspond with peak risk of MS by birth month. More research should be done on whether increasing UVB exposure or using vitamin D supplements and possible treatments or vaccines for the Epstein-Barr virus could lead to fewer cases of MS."
The research is published in the April 19, 2011, print issue of Neurology, the medical journal of the American Academy of Neurology.

If having mono as a teen and having low levels of vitamin D do equate to an MS diagnosis, then that would help to explain my diagnosis.  I had a pretty severe case of mono when I was a junior in high school (so bad that my spleen had enlarged to the point that the doctor was worried that the slightest blow to that area of my body would rupture my spleen).  Also, I recently got my vitamin D levels checked after learning about the potential impact of vitamin D on MSers and my levels were low.  I have been taking supplements and hopefully in a year, my levels will be up.  I find this "discovery" to be so interesting; I would love to know how many people living with MS had mono when they were younger.

For those MSers who have issues with balance, this BalanceWear vest may be the answer (or at least helpful):

Have balance and walking difficulty? The newly introduced BalanceWear® Therapeutic Garment utilizes Balance-Based Torso Weighting® (“BBTW®”), a novel technique used by some physical therapists to improve balance and mobility. The technique, which requires you to wear a customized, strategically weighted garment utilizing small, unobtrusive weights, is adjusted specifically to your body. BalanceWear is currently available in California, New York, Wisconsin, Delaware, Connecticut, and North Dakota with additional states being added constantly.
Individuals for whom the BalanceWear vest is recommended by a physical therapist certified in its use, can apply for funding through the MSF to pay for the entire cost of the garment.

To find a certified therapist near you, contact Motion Therapeutics, Inc., developers of the BalanceWear Therapeutic Garment, at 805-278-BBTW (2289).
To learn more about how this technology may help you, visit http://www.motiontherapeutics.com/.

Last, but not least, the makers of teriflunomide are recruiting patients for their clinical trials (Phase III - Teiflunomide vs. Placebo), the qualifications are listed below:

This study is recruiting in locations nationwide. The primary objective of this study is to demonstrate the effect of teriflunomide (14 mg/day and 7 mg/day) compared to placebo for reducing conversion of patients presenting with their first clinical episode consistent with MS to clinically definite MS.
It is an international, multi-center, randomized, double-blind, placebo-controlled, parallel group study and is designed to evaluate the efficacy and safety of two year treatment with teriflunomide.
Qualified participants will be between the ages of 18 and 55, male and female. Other inclusion criteria:
People with a first acute or subacute, well-defined neurological event consistent with demyelination (such as optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes.)
Onset of MS symptoms occurring within 60 days of randomization.
A screening MRI scan with two or more T2 lesions at least 3 mm in diameter that are characteristic of MS.
For more information go to http://click.icptrack.com/icp/relay.php?r=28288047&msgid=399143&act=X8WI&c=263560&destination=http://www.clinicaltrials.gov/ and search for identifier number NCT00622700.

I have been getting a lot of information lately that I want to share.  The newest Momentum magazine has an interesting article about Vitamin D and everyone seems to be reporting about the promising progress BG-12 and Laquinimod are making in their clinical trials.  I will try to post again soon! 

More From The MSF Mailer

Here is more news from the MSF Mailer I recently received.  In addition to the news about Gilenya and CCSVI  (See MS News Never Stops), the mailer discussed a number of other topics.  Including, news that BG-12 appears to be showing positive results in its clinical trials:

Though detailed data has not yet been released, Biogen Idec has reported “top-line” results  from the first phase three trial to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis (RRMS).
Results of the DEFINE trial showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a “highly statistically significant reduction” in the proportion of people with RRMS who relapsed at two years compared with placebo, Biogen said.
The company noted that both doses of BG-12 also provided a “statistically significant” reduction in annualized relapse rate, in the number of new or newly enlarging T2 hyperintense lesions, in new gadolinium-enhancing lesions, and in the rate of disability progression as measured by the Expanded Disability Severity Scale (EDSS) at two years.
Initial data from the trial showed that BG-12 demonstrated a favorable safety and tolerability profile, according to Biogen. The overall incidence of adverse events and serious adverse events was similar among the placebo group and both BG-12 treatment groups. The safety profile was consistent with what was seen in the published phase two study of BG-12. Further analyses of the DEFINE study are ongoing, and the company anticipates presenting detailed data at a future medical meeting.
Data from scientific studies suggest that BG-12 has the potential to be distinctive by reducing the entry into and the action of inflammatory cells on the central nervous system (CNS), as well as potentially protecting CNS cells from oxidative stress and death by activation of a critical pathway.
BG-12 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in 2008. In addition to DEFINE, another phase three RRMS clinical trial, CONFIRM, is currently underway. This study is evaluating BG-12 and glatiramer acetate, against placebo.  Clinical relapse, magnetic resonance imaging (MRI) measures of MS, progression of disability, and safety will be recorded. Results from CONFIRM are expected in the second half of 2011.

The mailer also, discussed the exciting progress laquinimod is making in its clinical trials:

The drug laquinimod reduced the number of relapses for people with MS in a large, long-term Phase III clinical study that was presented as late-breaking research at the 63rd Annual Meeting of the American Academy of Neurology, April 9–16, 2011, in Honolulu.
The study, supported by Teva Pharmaceticals, involved 1,106 people with relapsing-remitting MS in 24 countries. The participants received either a once-daily oral dose of 0.6 milligrams of laquinimod or a matching placebo for two years. Eighty percent of those taking laquinimod and 77 percent of those taking the placebo finished the two-year study.
Participants treated with laquinimod experienced a statistically significant reduction of 23 percent in annual relapse rate, compared to participants treated with a placebo. Additionally, there was a reduction of 36 percent in disability progression, as well as a 33 percent reduction in brain atrophy for those treated with laquinimod.
“These exciting results confirm that laquinimod has a significant impact on progression of disability and disease activity, while maintaining a high safety profile,” said lead author Giancarlo Comi, M.D., director of the Department of Neurology and Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan, Italy.
“This may be attributed to the novel mechanism of action of laquinimod, which effectively and safely addressed both the acute inflammatory activity and the accumulation of irreversible tissue damage. This suggests a substantial future role for laquinimod in the treatment of MS.”
Laquinimod was safe and well tolerated, according to the study authors. Overall frequencies of adverse events were low and comparable to those observed in the placebo group. “The incidence of liver enzyme elevation was higher in laquinimod treated patients,” said Comi. “However, these elevations were temporary, reversible, and did not lead to any signs of liver problems.”

Great to hear that such promising progress is being made on more oral therapies!

There was also information in the mailer regarding the research that may have discovered the driving force behind MS and may be on track to find a cure:

Neuroscientists have reported identifying a driving force behind autoimmune diseases such as MS, and suggest that blocking this cell-signaling molecule is the first step in developing new treatments to eradicate these diseases.
Researchers led by Abdolmohamad Rostami, M.D., Ph.D., Professor and Chairman of the Department of Neurology at Jefferson Medical College of Thomas Jefferson University, found that GM-CSF, which stands for Granulocyte-macrophage colony-stimulating factor, appears to be the key culprit in the onset of MS. Without GM-CSF, T helper 17 cells (Th17) cells did not induce the MS-like disease in an experimental animal model.
These findings were recently published in an advanced, online publication of Nature Immunology.
Th17 cells have been shown to play an important pathogenic role in humans and experimental models of autoimmune diseases, but the mechanisms behind this have not been understood until now.
"There was no connection between GM-CSF and Th17 cells before," said Dr. Rostami. "What we have shown in this paper is that GM-CSF
"Now we know how the Th17 cells work and a better understanding of this mechanism and biology leads to new therapeutics," he adds.
The results suggest that blocking GM-CSF activity may be a successful therapeutic strategy in MS, one of the most common neurological diseases affecting young adults, and other autoimmune diseases, said Dr. Rostami, who is also the Chair of Neurology at Thomas Jefferson University Hospital.
These findings identify the interleukin-23 (IL-23)/ Th17/GM-CSF axis as the major pathway in pathogenesis of autoimmune central nervous system inflammation and likely other autoimmune diseases. IL-23, a known cytokine that causes autoimmune inflammation of the brain, induces production of more GM-CSF in Th17 cells, the researchers explain.
Dr. Rostami, who is also director of the Neuroimmunology Laboratory in the Department of Neurology at JMC, and his colleagues used an animal model of MS called experimental autoimmune encephalomyelitis (EAE) for the investigation, a common model used to study the pathogenesis of the disease. Mice whose Th17 cells cannot produce GM-CSF did not develop neuroinflammation, thus GM-CSF is responsible for disease manifestation in this experimental model.
Another recently published paper in Nature Immunology by Dr. Rostami and his team unraveled a mechanism that may help fight MS. The researchers found that a protein known as interkeukin-27 (IL-27) helped block, not induce, the onset of symptoms in animals with an MS-like disease. While increasing levels of GM-CSF may cause the disease, as shown in the current paper, increasing IL-27 concentrations may help quell an over-active immune system, the researchers reported.

For more about this topic, see Research Only Ends with a Cure.  There were a few other topics discussed in the mailer, which I will discuss in the third and final series of the MSF Mailer news update.

In other news, I went to my first NMSS Advisory Board meeting and am going to continue to attend (making me an Advisory Board member)!  I am so excited to be more involved in the fight against MS!  Looking forward to helping out in any way that I can.

And a quick update on me: still feeling well - no everyday symptoms.  I still experience some minor "flare-ups" when I get my core temperature up, but otherwise I am doing well!  I am playing volleyball again tomorrow and I am going to try to play co-ed softball this summer (hopefully the heat doesn't get to me too much).  I'll keep you updated!

MS News Never Stops

News from the Multiple Sclerosis mailer that I get included good news regarding Gilenya:

A new analysis demonstrated that Gilenya (fingolimod) reduced the risk of disability progression in people with relapsing-remitting multiple sclerosis (RRMS), regardless of treatment history. This analysis of the phase III two-year FREEDOMS study was presented at the 63rd annual meeting of the American Academy of Neurology (AAN).
In the two-year FREEDOMS study, Gilenya reduced relapses by 54 percent compared to placebo. Also, Gilenya showed a 30 percent reduction in the risk of three-month confirmed disability progression as compared to placebo over two years.
The FREEDOMS analysis presented this week at AAN showed that 0.5 mg Gilenya-treated participants who were new to therapy had a 37 percent reduction in the risk of three-month confirmed disability progression compared to placebo. For those previously treated with alternate therapies, Gilenya 0.5 mg led to a 30 percent reduction in risk.

And news that a recent study cast doubt on the theory that CCSVI causes MS (I never believed that it actually caused MS, but there definitely seems to be some relation / correlation and the CCSVI procedure definitely seems to help some MSers):

A just-released study on the relationship between MS and chronic cerebral venous insufficiency (CCSVI) found that CCSVI may be a result of MS, not a cause, according to researchers.

A narrowing of the extracranial veins that restricts the normal outflow of blood from the brain, CCSVI has been a much-discussed topic in the MS community and among healthcare providers since it was first publicly described as a possible cause of the disease in October 2009.

The study, conducted by University at Buffalo (UB) researchers, appears in the current issue of Neurology, the journal of the American Academy of Neurology. Robert Zivadinov, M.D., Ph.D, associate professor of neurology in the UB School of Medicine and Biomedical Sciences and president of the International Society for Neurovascular Disease, is first author on the paper.

"Our results indicate that only 56.1 percent of MS patients and 38.1 percent of patients with a condition known as clinically isolated syndrome (CIS), an individual's first neurological episode, had CCSVI.

"While this may suggest an association between the MS and CCSVI, association does not imply causality. In fact, 42.3 percent of participants classified as having other neurological diseases (OND), as well as 22.7 percent of healthy controls involved in the study, also presented with CCSVI.

"These findings indicate that CCSVI does not have a primary role in causing MS," says Zivadinov. "Our findings are consistent with increased prevalence of CCSVI in MS, but substantially lower than the sensitivity and specificity rates in MS reported originally by the Italian investigators."

The results of the UB study are based on 499 participants in the Combined Transcranial and Extracranial Venous Doppler Evaluation (CTEVD) study, which began at the university in April 2009.

Prevalence rates were calculated in three groupings: only subjects with positive and negative CCSVI diagnoses; only borderline cases included in the negative group; and subjects who fulfilled any of the five criteria.

When only positive and negative CCSVI cases were considered, results showed a CCSVI prevalence of 62.5 percent in MS patients, 45.8 percent in those with OND, 42.1 percent in CIS, and 25.5 percent in healthy controls.

When borderline cases were included as negative for CCSVI, prevalence figures were 56.1 percent in MS patients, 42.3 percent in those with OND, 38.1 percent with CIS, and 22.7 percent in healthy controls.

The mailer also discussed BG12, Laquinimod, Medical Marijuana for MSers, Teriflunomide, and other topics.  I will discuss these issues in later posts. 

On another note, I was invited to be a member of my local NMSS chapter's Advisory Board.  I am very excited to attend a meeting tomorrow!  I can't wait to be more involved with the organization and I hope to bring something to the table!  Anyone have any great ideas for fundraisers or other events to promote awareness?

Research Research Research!

I have been pretty tired lately, but I am determined to continue to post at least once per week!

I just got around to reading emails that have been accumulating for the past few days and I learned that recently the National MS Society (NMSS) committed $17.5 million to support 50 new MS research projects.  This is all "part of its comprehensive strategy to stop MS in its tracks, restore function that has been lost, and end the disease forever."  The following is from the NMSS website:

To find the best research projects, the National MS Society relies on more than 70 world-class scientists. These scientists volunteer their time to carefully evaluate hundreds of proposals every year.
The new projects support the comprehensive research goals outlined in the Society’s five-year Strategic Response, including an increased focus on understanding and stopping disease progression, supporting development of new therapies, identifying rehabilitation and other strategies to restore function, and getting more researchers and scientists focusing on MS. The new projects include:

• clinical trials testing whether vitamin D can stop MS activity
• a clinical trial to evaluate whether a repurposed drug, phenytoin, can protect the nervous system from MS damage;
• investigations of mechanisms that may lead the immune system to turn against the nervous system;
• studies of natural molecules that may stimulate repair of the nervous system to restore function; 
• studies exploring novel exercise programs to combat MS symptoms; and
• a study comparing the activity of several viruses, including Epstein-Barr virus, that may be involved in triggering immune attacks in people with MS, which may lead to clues to ending MS through prevention. 

This is so great!  I am so happy to know that so much research is ongoing!  I am also glad to know that all of that money we all raise every year for Walk MS, Bike MS and a number of other NMSS events is going toward all of this exciting research!  I am especially excited to learn more about this Vitamin D theory.  Personally, I have been taking Vitamin D supplements since the Valentine's Day teleconference and I would love to know if those are helping in any way.

I also learned that the oral drug BG-12, which I previously posted about here, which is in clinical trials recently reported some positive results.  The following are excerpts from the NMSS website:

Biogen Idec announced that the experimental oral therapy BG-12 significantly reduced the proportion of people with MS who experienced relapses in a two-year study of more than 1200 people with relapsing-remitting MS. Although its exact mode of action is not known, BG-12 is thought to inhibit immune cells and molecules involved in MS attacks on the brain and spinal cord. The results were announced in an April 11 press release. Data analysis is ongoing and the company expects to provide a full report at an upcoming medical meeting. Another trial of BG-12 is currently underway.
In an earlier phase 2 study, compared to inactive placebo, the highest tested BG-12 dose led to a 69% reduction in active inflammation on MRI scans from weeks 12 to 24. Side effects (formally known as adverse events) included abdominal pain, flushing, headache, fatigue, and feeling hot.
The primary goal of the DEFINE study was to determine whether BG-12 could decrease the proportion of participants experiencing relapses and whether the agent was safe and well tolerated. Secondary objectives included assessing BG-12’s effects on the frequency of relapses, disability progression, and disease activity detected by MRI.
Participants were randomly assigned to one of two treatment groups receiving different doses, or a group receiving placebo. According to the press release, in both groups taking BG-12, the primary endpoint was met, meaning a significant reduction in the proportion of people experiencing relapses at 2 years. All secondary endpoints were met as well in these groups, with significant reductions in relapse rate, disease activity on MRI scans, and in disability progression as detected by the EDSS, a standard scale that measures disability. According to the press release, adverse events were similar to those experienced during the Phase 2 study (those included abdominal pain, flushing, headache, fatigue, and feeling hot):
These positive results are the first reported from this large, Phase 3 study of BG-12. Full details and evaluation of this study, and from another Phase 3 study now underway, should help define the safety and promise of BG-12 as a potential therapy for relapsing MS.

More good news!  Maybe soon a second oral therapy will be available!  That is enough news for one night, but everyone should also check out the Emerging Therapies Collaborative at this website.  Also, if you have a chance, you should check out this MS blog.

Hope everyone reading is well!  Look forward to another post by the end of the weekend!