Latest News
Lesion Location Matters
A 10 year study suggests that the location of T2 brain lesions is an important contributor to the progression of disability in primary progressive MS (PPMS).
The prediction of the long-term clinical outcome in people with PPMS remains challenging, with major clinical implications in providing advice to individual patients.
Eighty patients with PPMS were followed over ten years with MRI scans taken after 0, 1, 2, 5 and 10 years. Whole brain T2 lesion load was measured as an objective sign of tissue damage.
Researchers found the location of T2 lesions early in the disease is independently associated with the rate of progression in PPMS over a ten year period. The study also reinforced previous results that suggest that a proportion of all the lesions in the brain are ‘clinically silent’ that is they don’t produce visible symptoms.
Unfortunately, there are still no proven therapies for the treatment of PPMS. However, studies like this elucidate the biological mechanisms that drive disease course and suggest a direction for further research to develop efficacious treatments.
The full article is freely available here
New MS Drug Granted Fast Track Status by FDA
Alemtuzumab, an IV treatment for relapsing-remitting MS, is poised for an expedited FDA review when the current Phase III trial is completed.
The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Alemtuzumab, also known as Campath, was originally developed to fight cancer could help People with MS during the early stages of the disease. A Phase II trial has shown that alemtuzumab reduces the risk of relapse and accumulation of disability by over 70% compared with interferon beta in patients with early relapsing-remitting multiple sclerosis (MS).
Source: Genzyme
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Outcomes of bladder rehabilitation in people with multiple sclerosis
A multifaceted, individualised bladder rehabilitation programme reduces disability and improves QoL in pwMS compared with no intervention after 12 months of follow-up.
Bladder problems are a frequently reported symptom by People with MS (PwMS). Urinary dysfunction produces significant morbidity and psychosocial burden for PwMS. In fact, the severity of MS correlates with the severity of bladder symptoms. Until now there’s been minimal research published examining the effectiveness of individualised bladder management rehabilitation.
Australian researcher Dr Fary Khan and her colleagues at Royal Melbourne Hospital have shown a multifaceted, individualised bladder rehabilitation programme reduces disability and improves QoL in PwMS compared with no intervention. Specifically, 40 PwMS received an inpatient (IP) or outpatient (OP) bladder rehabilitation programme while the control group of 34 patients received their usual care.
The IP programme included three hours of therapy per day, involving all relevant allied health disciplines based on patient need over 6 weeks. The OP programme offered a lower intensity of therapy which included 30 min blocks of therapy sessions, 2 to 3 times/week as needed, for 6 weeks. Subsequently they were involved in maintenance programmes similar to those undertaken by the control group. The methods used in therapy were individually tailored to meet patient need.
This study supports early intervention and education for bladder management for pwMS. This is the first stratified, randomised waitlist controlled study over 12 months to assess individualised MD rehabilitation programmes in reducing bladder related disability in pwMS compared with no intervention. Improved awareness and understanding of currently available treatment options can improve patient outcomes.
Dr Fary Khan is the recipient of MSRA’s Ian Ballard Travelling Fellowship. Read more about her research here
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FDA fast tracks MS drug
- Source: Reuters
Genzyme Corp has been granted fast-track status by the US Food and Drug Administration (FDA) to the company's experimental treatment for multiple sclerosis. With fast-track status Genzyme can submit data from clinical trials to the FDA on a rolling basis as it becomes available rather than waiting until pivotal studies are complete. Genzyme has said the drug, called alemtuzumab, is one of its most important experimental products. It is being tested for the relapsing-remitting form of MS. Read more here
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New oral drug gets initial approval from US advisory panel
Novartis AG said its investigational oral multiple sclerosis drug fingolimod (FTY720) has received unanimous approval from an FDA expert advisory committee, pending final approval from the regulator.
The FDA can seek the advice of one of its expert committees in deciding whether to approve a new treatment. The FDA usually follows the panel's recommendations, though is not obliged to do so. The final decision is expected by September 2010. Read more here
Information about Fingolimod is available from the MS Trust website
Source: International Business Times
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Glatiramer acetate recovers microscopic tissue damage in MS
Traditional magnetic resonance imaging (MRI) techniques have contributed to the management of MS but are limited in their ability to detect neuronal damage. Advanced MRI metrics provide assessment of microscopic neuronal changes; however, few studies have examined the effects of MS therapies on these measures. This prospective, open-label, observational study evaluated the effect of subcutaneous glatiramer acetate (GA) 20mg/day on the 1- and 2-year changes in diffusion-weighted imaging (DWI) measures in patients with relapsing-remitting (RR) MS and in age- and sex-matched healthy controls (HC). Patients on GA and HC did not develop significant global or regional atrophy (brain shrinkage) over 2 years. GA significantly improved microscopic tissue damage in the brain, as measured by DWI over the 1- and 2-year follow-up. Read more here
Source:PubMed
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Enhanced neural drive after maximal strength training in multiple sclerosis patients
Multiple sclerosis (MS) patients suffer from impaired muscle activation and lower limb strength. Strength training enhances muscle activation and muscle strength, but neural adaptations to strength training remain unexplored in MS patients. The hypothesis was that maximal strength training (MST) using high loads and few repetitions would improve central neural drive and thus strength capacity of MS patients. 14 MS patients staying at a national MS rehabilitation center were randomly assigned to a MST group or a control group (CG). Both groups received "today's treatment". In addition, the MST group trained 4 x 4 repetitions of unilateral dynamic leg press and plantar flexion 5 days a week for 3 weeks. This randomized study provides evidence that MST is effective of augmenting the magnitude of efferent motor output of spinal motor neurons in MS patients, alleviating some neuromuscular symptoms linked to the disease.
Source: PubMed
A Phase I clinical trial at Frenchay Hospital, Bristol, UK using autologous bone marrow stem cells to treat MS conducted by researchers from the University of Bristol has shown encouraging results.
In this trial six patients were injected with stem cells harvested from their own bone marrow with the study aiming to determine whether the treatment is safe. There were no serious side effects from the procedure and patient's conditions remained stable over 12 months. The researchers hope to further investigate the effectiveness of the treatment later this year.
Alternate protein kinase A activity identifies a unique population of stromal cells in adult bone, PNAS, (subscription required) with commentary from HealthDay and press release from NIH.
Source: Australian Stem Cell Centre
Innate Therapeutics announced funding support from Fast Forward, a not-for-profit organization established by the U.S. National Multiple Sclerosis Society and EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany. The funds will help support the conduct of a Phase 2A clinical trial in patients with progressive forms of MS using MIS416, a naturally occurring agent derived from bacteria. “We are delighted to gain this substantial funding as well as to be able to work with Fast Forward and their collaborative partner, EMD Serono,” said Simon Wilkinson, the Chief Executive Officer of Innate Therapeutics.
More information is available here http://www.innatetherapeutics.com/
Oral teriflunomide has been shown to have acceptable tolerability and safety over 24 weeks of treatment when combined with interferon-beta. Teriflunomide improved disease control beyond that achieved with interferon-beta alone, reducing the number of Gd-enhancing T1 lesions. Additional data will fully determine the clinical benefit of this new combination treatment approach. More information about the study is available here
Two teriflunomide clinical trials are underway in Australia and more information is available through MSRACTN Register:
Source: sanofi-aventis
Genzyme Corp announced at the annual meeting of the American Academy of Neurology new clinical trial data of an experimental MS drug that if approved will be the most effective drug available to People with MS. The data showed that after four years, 71 percent of patients had no relapses or worsening of disability. Read the full article here
Source: Reuters
Biogen Idec Inc are developing a screening tool to test if patients treated with Tysabri are developing a deadly brain illness from the drug. The screening tool could be available as early as 2011 if clinical trials involving 9,000 people show that it can accurately detect the JC virus that causes progressive multifocal leukoencephalopathy or PML resulting in brain-cell death, disability and if untreated early, death. Tysabri has been linked to 42 PML. For more information http://www.reuters.com/article
Source: Reuters
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Researchers from Stanford University report that a blood test might make it possible to identify which MS patients will respond to therapy. Published online in Nature Medicine, a simple blood test could indicate which MS patients are most likely to benefit from beta-interferon, an injectable drug which helps to minimize relapses of the disease. The Stanford researchers identified two distinct chemical pathways through which the body’s inflammatory response triggers MS relapses. One of these pathways corresponded to people who responded to beta-interferon and the other pathway corresponded to those who did not.
More information available here
Source: Nature Medicine
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Facet Biotech and Biogen Idec recently released results from a phase 2 study of daclizumab in active relapsing multiple sclerosis (CHOICE study). Daclizumab reduced MS disease activity in previous non-randomised studies. The study assessed whether daclizumab reduces disease activity in patients with active relapsing MS who are receiving interferon beta treatment. The results suggested that add-on daclizumab treatment reduced the number of new or enlarged gadolinium contrast-enhancing lesions compared with interferon beta alone and might reduce MS disease activity to a greater extent than interferon beta alone. More information is available here
Source: The Lancet Neurology
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Results from the 15-year analysis of glatiramer acetate
The ongoing US Glatiramer Acetate (GA) Trial is the longest evaluation of continuous immunomodulatory therapy in relapsing-remitting multiple sclerosis (RRMS). The objective of this study was to evaluate up to 15 years of GA as a sole disease-modifying therapy. MS patients with mean disease duration of 22 years administering GA for up to 15 years had reduced relapse rates, and decreased disability progression and transition to SPMS. There were no long-term safety issues. The study is intended to continue for 20 years of followup. The full paper is freely available from Multiple Sclerosis here.
Source: Multiple Sclerosis
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BIIB033: Phase 1 Trial of Potential Regenerative Treatment
Biogen Idec is undertaking a phase 1 clinical trial of an experimental treatment called BIIB033. BIIB033 is designed to inhibit Lingo-1, a molecule that may be preventing myelin production in adults. Blocking Lingo-1 may encourage the regeneration of myelin after damage from MS occurs.
The trial has been listed on clinicaltrials.gov and will test if the drug is safe and tolerated in the body in 64 healthy individuals in the Netherlands. The results are expected early 2011. Read about the trial here
Source: www.clinicaltrials.gov
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Oral Therapies for MS
Reports in the New England Journal of Medicine (21 January 2010) indicate that clinical trials of the drugs Fingolimod and Cladribine show favourable results for treating the symptoms of MS. Fingolimod and Cladribine are pharmaceutical medications for relapsing-remitting MS and would be taken as capsules, as opposed to most currently available treatments, which are administered by injection.
MS Research Australia welcomes research into any new therapies which may give people living with MS more options for the reduction in disease activity and the strong possibility of less long term disability.
However, despite the exciting phase III trial data reported today these drugs are still at clinical trial stage and are yet to go through the required Therapeutic Goods Administration (TGA) assessment and other approval processes for use in Australia.
We are looking forward to the results of these assessments by the regulatory authorities in Australia to determine when these drugs will be available to help people with MS in Australia.
MSRA’s Scientific Chairman Prof Bill Carroll, featured in the same publication, gives details of each of these trials, click here for article.
Source: New England Journal of Medicine
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Acorda Therapeutics Announces FDA Approval of AMPYRA(TM) to Improve Walking in People with MS
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA(TM) (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). AMPYRA can be used alone or with existing MS therapies, including immunomodulator drugs.Read more here
Source: Acorda Therapeutics
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Neuropsychiatric manifestations in multiple sclerosis: correlation of fatigue and depression with disease progression
Aug 2009 - Clinical research provides further support of a complex interplay of fatigue and depression with disability. Read more here
Source: Neurol Res. 2009 Aug 5.
Find out about MSRA funded research relating to fatigue and MS here
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Exclusive breast-feeding and the risk of postpartum relapses in women with MS
Aug 2009 - A recent clinical trial suggests that exclusive breast-feeding and with concurrent suppression of period blood flow significantly reduce the risk of MS relapses after pregnancy. These findings call into question the benefit of foregoing breast-feeding to start MS therapies and should be confirmed in a larger study. Read more here
Source: Arch Neurol. 2009 Aug;66(8):958-63. Epub 2009 Jun 8
Find out about MSRA funded research relating to pregnancy and MS here
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Effectiveness of applying progressive muscle relaxation technique on quality of life of patients with MS
Aug 2009 - Recent clinical research from the Fasa University of Medical Science (Iran) shows modest support for the effectiveness of progressive muscle relaxation technique on quality of life of MS patients. Read more here
Source: J Clin Nurs. 2009 Aug;18(15):2171-9
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New Data from CLARITY Study Presented at 19th ENS Meeting Show Rapid and Sustained MS Relapse Reduction for Cladribine Tablets
June 22, 2009 - The effect of short-course oral treatment with Cladribine Tablets on annualized relapse rate was significant as early as 12 weeks after initiation of treatment and sustained through to the 96 weeks of the study. Read more here
Source: Merck Serono
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First Ten-Year Follow-Up Shows That Treatment with AVONEX® Leads to Long-Term Benefits in Early Multiple Sclerosis Patients
SEATTLE, WA - April 30, 2009 - Biogen Idec (NASDAQ: BIIB) today announced data results from the CHAMPIONS (Controlled High-Risk AVONEX® (interferon beta-1a) Multiple Sclerosis (MS) Prevention Study In Ongoing Neurologic Surveillance) study, an open label follow-up to CHAMPS (Controlled High Risk Subjects AVONEX MS Prevention Study). Based on the CHAMPS study, AVONEX was granted approval for use in patients who experienced their first clinical MS episode with MRI findings. The CHAMPIONS ten-year follow up showed that patients treated immediately after their first episode had significantly less chance of experiencing a second attack versus those patients with delayed treatment. These results at ten years also indicate that 80 percent of patients taking AVONEX were below an expanded disability status scale (EDSS) score of three. These data were presented as a poster at the Annual American Academy of Neurology (AAN) meeting. Read more here
Source: Biogen Idec
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Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients with Multiple Sclerosis
April 29, 2009 -
- Primary endpoint met with a significant reduction in relapse rate
- Secondary endpoints met including MRI measures, proportion of patients relapse-free and disability progression
Source: Merck Serono
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MS PATIENTS TREATED WITH TYSABRI® REMAIN FREE OF DISEASE ACTIVITY FOR TWO YEARS, ACCORDING TO DATA PUBLISHED IN THE LANCET NEUROLOGY
Cambridge, MA and Dublin, Ireland - February 9, 2009 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced five-times as many multiple sclerosis (MS) patients taking TYSABRI® (natalizumab) were free from disease activity versus placebo in the overall patient population. Results from this retrospective analysis showed that two years after beginning treatment with TYSABRI, 37 percent of patients remained free of disease activity, compared to seven percent of placebo-treated patients. Sixty-four percent of patients showed no sign of relapse or sustained disability progression and 58 percent were free of radiological disease activity. Both of these measures were used to define freedom from disease activity in this analysis of the AFFIRM clinical trial. These data were published online today and in the March 2009 issue of The Lancet Neurology.Read more here
Source: Biogen Idec
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Merck Serono’s Oral Investigational Treatment Cladribine Tablets for Multiple Sclerosis Significantly Reduced Relapse Rate in Two-Year Phase III Pivotal Trial
January 23, 2009 -
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Two-year primary efficacy endpoint of CLARITY trial met: 58% relative reduction in annualized relapse rate in the low total dose treatment group and 55% in the high total dose treatment group
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Cladribine tablets are the first oral investigational multiple sclerosis treatment to complete a two-year pivotal study
Source: Merck Serono