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Thursday, June 9, 2016

Metabolite of multiple sclerosis drug could be safe, effective therapy for Parkinson's disease


                                                                  
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Metabolite of multiple sclerosis drug could be safe, effective therapy for Parkinson's disease
(left) Dr. John Morgan, neurologist, neuroscientist and Parkinson's disease specialist in the MCG Department of Neurology and Dr. Bobby Thomas, neuroscientist in the Department of Pharmacology and Toxicology at the Medical College of Georgia at Augusta University. Credit: Phil Jones
June 8, 2016

The metabolite of a drug that is helping patients battle multiple sclerosis appears to significantly slow the onset of Parkinson's disease, researchers say.

The oral drug, dimethylfumarate, or DMF, and its metabolite, monomethylfumarate, or MMF, both increase activity of Nrf2, a protein that helps protect the body from  and inflammation, hallmarks of both diseases, said Dr. Bobby Thomas, neuroscientist in the Department of Pharmacology and Toxicology at the Medical College of Georgia at Augusta University.
But the new study provides the first evidence that the metabolite, which is essentially the active portion of the parent drug, more directly targets Nrf2, potentially reducing known side effects of the parent drug that include flushing, diarrhea, nausea, vomiting, abdominal pain and the brain infection encephalopathy, said Thomas, corresponding author of the study in The Journal of Neuroscience.
Particularly, the gastrointestinal side effects can exacerbate some problems  with Parkinson's already experience, said Dr. John Morgan, neurologist, neuroscientist and Parkinson's disease specialist in the MCG Department of Neurology. In addition to destroying neurons in the brain that produce dopamine, a neurotransmitter that enables movement and learning, Parkinson's causes nerve cell death in the gastrointestinal tract and related problems such as severe constipation.
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Foot Drop - the cause, symptoms and treatments


                                                                  
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Foot Drop Overview:

Foot drop, sometimes called drop foot, is a general term for difficulty lifting the front part of the foot. If you have foot drop, you may drag or bump the front of your foot on the ground when you walk. Foot drop in itself is not a disease but rather a sign of an underlying neurological, muscular or anatomical problem.
Some of the common reasons patients present with foot drop include stroke, spinal cord injury or injury to the peroneal nerve on the outside of the fibula, below the knee. ALS (Lou Gehrig’s disease), Parkinson’s disease and multiple sclerosis can also lead to foot drop. Patients who have had a total knee replacement can also present with foot drop, although that is less likely.
In a normal walking gait cycle, the toes pull up from the floor so a person avoids tripping on them. The toes of foot drop patients point down and strike the floor first, with their ankle flapping as they move the foot. They may develop a steppage or marching walking gait, raising their thigh when walking in a motion similar to climbing the stairs to avoid striking the front of their foot against the ground. Another coping mechanism is raising the leg and slightly bending at the knee to prevent the foot from dragging along the ground. Other gaits such as a wide outward leg swing (to avoid lifting the thigh excessively or to turn corners in the opposite direction of the affected limb) may also indicate foot drop.
Foot drop typically affects only one foot. Depending on the underlying cause, however, it’s possible for both feet to be affected.
Foot drop is a complicated condition in many cases including that of multiple sclerosis (MS).
Falling down due to foot drop is a serious hazard.  If you suspect that you are experiencing foot drop as a new presenting symptom and live with multiple sclerosis it is important for you to see your neurologist as soon as possible.  As a new presenting symptom you may be undergoing a new exacerbation (flare up) or problem relating to an existing lesion.  Do not wait as drop foot can be a serious risk and is best addressed as soon as it presents itself.
Foot Drop Symptoms:

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Genmab Announces Phase III Studies of Ofatumumab in Relapsing Multiple Sclerosis


                                                                  
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  • Phase III trials (ASCLEPIOS I and II) with the subcutaneous formulation of ofatumumab in Relapsing Multiple Sclerosis
  • Studies expected to begin enrolling in September 2016
Copenhagen, Denmark; June 2, 2016 — Genmab A/S  announced today that its collaboration partner Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrolment of patients expected to start in September 2016. The studies will compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS. Details of the studies will shortly become available on clinicaltrials.gov.
“Ofatumumab has the potential to be a best-in-class anti B-cell therapy for relapsing MS,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to swift execution and outcome of these trials and to further development of ofatumumab in this disease area.”
About the ASCLEPIOS I and II studies
The Phase III trials are randomized, double-blind, double-dummy studies comparing the efficacy and safety of subcutaneous ofatumumab versus teriflunomide, a standard treatment in MS, in approximately 900 patients with relapsing MS per study.  Patients will be randomized to receive either subcutaneous injections of ofatumumab every four weeks or of teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo). The primary endpoint of the studies is annualized relapse rate (ARR), which is the number of confirmed relapses in a 12 month period. The studies will be conducted by Novartis.
About Multiple Sclerosis
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system that affects approximately 2.5 million people worldwide.1 MS is twice as common in females as in males, occurring with a peak incidence at the age of 30 years and incidence varies widely in different populations and ethnic groups. The etiology of MS remains unknown, but the geographic variation points towards possible environmental and genetic factors. Relapsing MS is characterized by unpredictable recurrent attacks and accounts for 80% of MS cases.2
About Ofatumumab
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes.
Ofatumumab is approved and marketed for intravenous use in certain chronic lymphocytic leukemia indications under the trade name Arzerra®. Please see full Prescribing Information, including Boxed WARNING for Arzerra.
Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis also has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.
Ofatumumab is not approved anywhere in the world as a treatment for relapsing MS.
About Genmab 
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.  Founded in 1999, the company has two approved antibodies, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX® (daratumumab) for the treatment of heavily pretreated or double refractory multiple myeloma. Daratumumab is in clinical development for additional multiple myeloma indications and for non-Hodgkin’s lymphoma. Genmab also has a broad clinical and pre-clinical product pipeline.  Genmab’s technology base consists of validated and proprietary next generation antibody technologies – the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies.  The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies.  For more information visit www.genmab.com.
Contact:           
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody®and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.
1. GlobalData. EpiCast Report: Multiple Sclerosis — Epidemiology Forecast to 2024. Published September 2015
2. Datamonitor. Multiple Sclerosis Treatment. Published January 2015
Company Announcement no. 28
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
http://ir.genmab.com/releasedetail.cfm?releaseid=973889 




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Wednesday, June 8, 2016

MS Advocacy Q&A - Synergy Topline Readout concerning anti-Lingo-1



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What is opicinumab (anti-LINGO-1)?


Opicinumab (anti-LINGO-1) is an investigational compound being developed as a potential neuroreparative therapy for the treatment of multiple sclerosis (MS).  In MS, the immune system attacks the myelin (fatty substance that surrounds and protects the nerve fibers) in the central nervous system (CNS), causing damage or destruction.  This process is called “demyelination.”  As the damage progresses, nerve cells may eventually die, likely contributing to physical and cognitive disability.[1]

Opicinumab (anti-LINGO-1) is being studied for its potential to regenerate the protective sheath around nerves (remyelination), which may help protect against additional cell damage and may restore some nerve cell function.  
Biogen hypothesizes that a neuroreparative therapy may repair damage caused by MS, which could result in improved neurologic function.


What is the difference between opicinumab (anti-LINGO-1) and existing MS disease-modifying therapies (DMTs)?
Existing DMTs control inflammation by modulating or suppressing the immune system and potentially impacting the course of the disease (e.g., reduction of relapses or slowing worsening of disability).
Opicinumab (anti-LINGO-1) does not control inflammation; it is being studied for its potential to regenerate the protective sheath around nerves (remyelination), which may help restore some nerve cell function.

What is the SYNERGY study?
SYNERGY is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study that evaluated the impact of opicinumab (anti-LINGO-1) among 418 participants with relapsing forms of MS (RMS), both relapsing-remitting and secondary progressive, over 72 weeks.  All study participants received concurrent treatment with 30 mcg interferon beta-1a intramuscular (IM) injections once weekly.

The primary objective of the SYNERGY study was to evaluate the efficacy of opicinumab (anti-LINGO-1) in participants with active RMS when used concurrently with interferon beta-1a IM.  The primary endpoint was the percentage of participants who experienced improvement relative to placebo on one or more of the following multicomponent measures: ambulation (Timed 25-Foot Walk; T25FW); upper extremity function (9-Hole Peg Test; 9HPT); cognition (3-Second Paced Auditory Serial Addition Test; PASAT); and a standard measure of physical disability (Expanded Disability Status Scale; EDSS).

The secondary efficacy endpoint was the percentage of participants who experienced worsening on the same multicomponent measures relative to placebo.  Other secondary objectives of the study were the safety and pharmacokinetics of opicinumab (anti-LINGO-1).


SYNERGY was the first Phase 2 MS study that evaluated improvement in clinical outcomes in participants being treated with a potential remyelinating agent.

[1] Chari DM. Remyelination in multiple sclerosis. Int Rev Neurobiol. 2007;79:589-620. 
Available at: http://www.ncbi.nlm.nih.gov/pubmed/17531860.  Accessed May 24, 2016.





What does “double-blind” mean?

“Double-blind” means that none of the participants, their care partners, the companies sponsoring the study, nor the study staff will know if the participant is/was assigned to the drug or placebo group while the study is ongoing.

What does “randomized, placebo-controlled, dose-ranging” mean?
A randomized and placebo-controlled study means everyone participating in the study was randomly assigned to receive interferon beta-1a IM and either placebo or one of four doses of opicinumab (anti-LINGO-1): 3 mg/kg; 10 mg/kg; 30 mg/kg; or 100 mg/kg.  A study with multiple doses is known as a “dose-ranging” study and is usually performed in the early stages of drug development to provide more information for future studies.
How is opicinumab (anti-LINGO-1) administered?
In the SYNERGY study, opicinumab (anti-LINGO-1) was administered as an intravenous infusion every four weeks at doses of 3 mg/kg, 10 mg/kg, 30 mg/kg or 100 mg/kg.  All study participants received concurrent treatment with 30 mcg interferon beta-1a IM injections once weekly.

What are the results of SYNERGY?
In the study, opicinumab (anti-LINGO-1) missed the primary endpoint which was a multicomponent measure evaluating improvement of physical function, cognitive function, and disability relative to placebo. However, evidence of a clinical effect with a complex, unexpected dose-response was observed. Biogen is planning to have additional information available at ECTRIMS in September if accepted.

Opicinumab also did not meet the secondary endpoint, which evaluated the slowing of disability progression. All study participants received concurrent treatment with 30 mcg interferon beta-1a intramuscular injection (IM) once weekly.

The SYNERGY results provide a rich data set that will advance our understanding of the potential to repair damage in the CNS caused by MS or other demyelinating diseases.  Biogen is continuing to analyze large amounts of data from this comprehensive Phase 2 study to inform potential next steps.




What were the side effects of opicinumab (anti-LINGO-1) seen in the SYNERGY trial?

Opicinumab was generally well-tolerated and the safety profile was consistent with what has been observed in prior studies.

What are the next steps? Will there be another study?
SYNERGY was a comprehensive Phase 2 study of 418 participants, so there are large amounts of data to be analyzed, including additional endpoints.  Biogen continues to analyze the data to inform the next step of the clinical development program, including the design of a next study. Biogen plans to present additional SYNERGY results at ECTRIMS if accepted.


Where can I go for further information about opicinumab (anti-LINGO-1) and/or SYNERGY?

Updates regarding the opicinumab (anti-LINGO-1) clinical trial program will be posted on www.clinicaltrials.gov.  You can access this information by searching (anti-LINGO or NCT01864148). Biogen plans to present additional SYNERGY study results at ECTRIMS if accepted.


We know that Biogen is conducting other neuroreparative studies. Since the trial results did not meet expectations, will you continue with the other studies? Will this affect the trial design of these other studies?

Biogen is evaluating the data and will assess any potential impact of SYNERGY on future studies. The SYNERGY results provide a rich data set that will advance our understanding around the potential to repair damage in the CNS caused by MS and other demyelinating diseases.  Biogen intends to use the findings from this study and other data as neuroreparative research efforts are continued. 

Once Biogen completes a thorough review of the SYNERGY data, Biogen will make and communicate an informed decision about next steps.

###




[1] Chari DM. Remyelination in multiple sclerosis. Int Rev Neurobiol. 2007;79:589-620. Available at: http://www.ncbi.nlm.nih.gov/pubmed/17531860.  Accessed May 24, 2016.




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A candid interview Clay Walker, American country music artist / MS patient


                                                                  
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Note from the editor: Multi-platinum Country music artist #ClayWalker won’t let MS slow him down. Diagnosed 20 years ago with RRMS at age 26 he continues strong and sat down to speak with Stuart Schlossman of MS Views and News at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Center (CMSC) in National Harbor, Maryland.

written by Jennifer Falk - June 3, 2016

 
                                               
Read about Clay Walker discussing the importance of his relationship with his neurologist, staying active while living with MS, family life and work.


When asked about his relationship with his neurologist:

Clay Walker: Since being diagnosed 20 years ago with MS my relationship is second only to my relationship with my family. My original medication did not work, I relapsed 3 times and my opinion of MS meds was very low.

My current doctor, he started me on Copaxone and looking back I was leaning towards just trying to get healthy through diet. I was in a very dark place and it was through his insistence and persistence that I got on meds. Being relapse free for 18 years that was the best (looking back) decision I could have possibly made.

My original doctor told me my prognosis was that I would be in a wheelchair and dead in 8 years. Physician patient relationship is important, along with love and support from family is important.

I am now doing #Copaxone 3x a week and there has been no difference, I do not feel any change.

I feel that my doctor is one of the brightest MS doctors around. He has dedicated his entire life to finding a cure and helping every patient he has, finding out which medication will work for them. There is nothing that makes him feel better than seeing a good patient outcome.

Stuart Schlossman: Has MS affected your career?

Clay Walker: I am touring, active and I have never missed a show, never called in sick. Today I golfed, most people will say, “that’s the life” but I do it to keep moving and keep walking. I have a bit of, maybe you can say, guilt because I don’t have fatigue. So MS has not affected me in the work space. It’s actually only encouraged me to actually love my job more because when I was originally diagnosed by the neurosurgeon, he told me that I’d be in a wheelchair in four years and dead in eight. So if you would have asked me, Clay, what would you do for 20 years on this earth, I’d say I’ll give you everything I own.

Stuart Schlossman: Do you ever have symptoms that affect your performance?

Clay Walker: Once in the beginning I could not hold a guitar pick…I could not feel my fingers. Although you can’t cure MS, now I wanted to prove through some physical exercises and stretches you can improve certain functions. I got evaluated by a neuro PT and I had weaknesses, and when I came back after working with a PT, stretches/exercise- I improved so much! Significant improvements.

“Even if you are in a wheelchair, if you have one limb- use it and you can see improvement”

Many people with MS think they can only go down, that all you can do is go down, but I am in the best shape of my life.

Stuart Schlossman: Tell us more about your symptoms

Clay Walker: The biggest symptom that I had came early on –loss of dexterity in my right hand. It took about two years to fully regain it all back. The symptom I live with now is a cold right foot – but I noticed when I ride horses my foot feels perfect! I had balance issues and started working with a physical trainer, standing on 2x4’s, balancing work on one foot, and it has really corrected itself. Although we can’t cure MS, we can make physical gains. Just recently I started noticing it was hard for me to recall a name, of someone I had written a song with. I wondered if this was cognitive MS stuff, but I don’t think so.

#StuartSchlossman: Age, memory or just forgetting!

Clay Walker: That’s true! I think we worry about MS a lot. I believe it is healthy you combat fear with good sensible reason.

Stuart Schlossman: How do you talk about MS with your children?
Clay Walker:  My children have fortunately grown up with me and my MS. I am a jovial Dad- I believe it is a father’s role to build the self-esteem of their children. They have seen me take my shot, they ask,“does it hurt?’  I say no. My kids are 7, 6 and 2 (years old) and they see me speak with an open mic in front of live audiences about MS, and they were listening when they heard me speak about my original prognosis of dead in 8 years. While I was giving that talk I thought I was not going to say that part, I knew it would affect the children, but I said it anyway.

This was the first time I had to explain this to them.

I have been able to live an authentic and fulfilled life with MS. By being authentic, this is whole and I do not hide.

 I always talk to my kids about getting frustrated, frustration begins, where knowledge ends. Let’s get knowledge. The more good true knowledge that a person living with #MS has through others living with MS and doctors that feeling alright starts to happen, and that’s when you get your MS under control.
There is a confidence that comes with that. 18 years without a relapse is an amazing feet for someone with MS.

Stuart Schlossman: Thank you Clay, it has been a real pleasure speaking with you again!


Clay Walker: Absolutely Stuart this was great, see you at the concert tonight         (June 2, 2016)