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!