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.

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!