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.

Friday, November 11, 2011

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.


  1. Question: Does BG-12 protect the myelin in any way or does the disease progress as if the medication wasn't being given? I realize this medication decreases relapses but I wonder if it protects the covering of the nerve pathway. Do you or anyone else know the answer to this?

  2. That was my question, also. If it doesn't reduce disability progression, then is it really a better treatment? What is it's purpose, other than fewer relapses, if it doesn't limit the progress of the disability? Just a question. I appreciate all of your research - I am just so impatient for an authentic answer to this disease. Keep up the good work. You are providing a great service.

  3. The following excerpt from a Reuters article ( http://mobile.reuters.com/article/idUSTRE79P2WI20111026?irpc=932) will hopefully clear up some confusion: "The CONFIRM study, unlike DEFINE, also tested BG-12 against Copaxone, a drug made by Teva Pharmaceutical Industries Ltd. Copaxone cut the annualized relapse rate by 29 percent.

    Biogen said BG-12 cut the rate of disability progression by 21 percent when given twice a day and by 24 percent given three times a day. That result was not statistically significant and compares negatively with the DEFINE trial, which showed a cut in the rate of disability progression of 38 percent.

    Biogen said the lack of statistical significance may be attributable to an unexpectedly low rate of disease progression in the placebo group. It said it is studying the data closely to better understand the figures.

    Copaxone cut the rate of disability progression by 7 percent."

    Thanks for the questions and thanks for reading!

  4. I'm on this ... extended study. it has neuro protective qualities, minimal side effectsm no malignancies, no relapses for wellover 2 years and let me tell you...I am better than I have been for a very long time!

    1. looking to speak with someone on BG12 extension study to gain patient perspective and experience in the study. sorry to post on this site, don't mean to infringe on patient group privacy. if willing to discuss (and be compensated for interview time), please email: mspatientexperience@gmail.com

  5. When is this drug planned to be marketed and offered as a treatment option for patients?

  6. We cannot know that at this point. They have to complete clinical trials and the drug would then need to be approved by the FDA. They may have a projected timeline, but it will depend. I will try to find out more.