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Here, you can read about the latest research into new drugs for MS and it's symptoms.








ANP reports positive results from chronic toxicity study of ATL1102 in multiple sclerosis(02/04/14)

Antisense Therapeutics Limited is pleased to advise that results from a chronic toxicity study in monkeys indicate that ATL1102, an antisense oligonucleotide currently under development for the treatment of multiple sclerosis (MS), was well-tolerated when given subcutaneously for a 6-month dosing period at the 2 dose levels tested (1.5 and 3mg/kg/dose). The Company believes that the preclinical and clinical experience to date with ATL1102 should allow dosing in future trials at or above the 1.5 mg/kg/dose level.

Based on histologic findings in common with a previous monkey study at doses exceeding 1.5mg/kg/dose, the Company continues to evaluate the chronic monkey data with regard to potential human relevance, and safety biomarkers that may be useful in future clinical studies. Exposures achieved in this study are regarded as potentially clinically relevant based on the efficacy outcomes from the previously conducted Phase IIa trial of ATL1102 in MS patients.

Pending receipt and final data evaluation from the current study, as well as review of all the preclinical and clinical data obtained, ANP is planning future regulatory agency discussions regarding further development of ATL1102 and the dosing regimen for a future Phase IIb trial in MS patients. The Company anticipates final review of the data by June this-year and follow-up discussions with the US Food and Drug Administration (FDA) at a pre-IND meeting during the 3rd quarter 2014.

Antisense Therapeutics CEO and Managing Director Mark Diamond said “The results of this most recent toxicology study and the human data to date are encouraging and re-ignite our hopes for this project. We are continuing to generate new data on ATL1102 which we believe will support positive interactions with the FDA in relation to our plans for a future Phase IIb trial in MS patients. We look forward to confirming our plans for the further clinical development of ATL1102 with the FDA in the coming months.”

Source: www.news-medical.net/ (02/04/14)

Therapy optimisation in MS: a prospective observational study of therapy compliance and outcomes(14/03/14)

Data sources for MS research are numerous but rarely provide an objective measure of drug therapy compliance coupled with patient-reported health outcomes. The objective of this paper is to describe the methods and baseline characteristics of the Therapy Optimisation in MS (TOP MS) study designed to investigate the relationship between disease-modifying therapy compliance and health outcomes.

Methods: TOP MS was designed as a prospective, observational, nationwide patient-focused study using an internet portal for data entry.

The protocol was reviewed and approved by Sterling IRB. The study was registered with ClinicalTrials.gov.

It captured structured survey data monthly from MS patients recruited by specialty pharmacies. Data collection included the clinical characteristics of MS such as MS relapses.

Disability, quality of life and work productivity and activity impairment were assessed quarterly with well-validated scales. When events like severe fatigue or new or worsening depression were reported, feedback was provided to treating physicians.

The therapy compliance measure was derived from pharmacy drug shipment records uploaded to the study database. The data presented in this paper use descriptive statistics.

Results: The TOP MS Study enrolled 2966 participants receiving their disease-modifying therapy (DMT) from specialty pharmacies.

The mean age of the sample was 49 years, 80.4% were female, 89.9% were Caucasian and 55.7% were employed full or part time. Mean time since first symptoms was 11.5 years; mean duration since diagnosis was 9.5 years.

Patient-reported EDSS was 3.5; 72.2% had a relapsing-remitting disease course. The most commonly reported symptoms at the time of enrollment were fatigue (74.7%), impaired coordination or balance (61.8%) and numbness and tingling (61.2%).

Half of the sample was using glatiramer acetate and half was using beta-interferons.

Conclusion: Demographic and clinical characteristics of the TOP MS sample at enrollment are consistent with other community-based MS samples, and the sample appears to be representative of DMT users in the US. TOP MS data can be used to explore the associations between disease-modifying therapy compliance and health outcomes.Trial registration: ClinicalTrials.gov (NCT00819000).

Author: Patricia K CoyleBruce A CohenThomas LeistClyde MarkowitzMerriKay Oleen-BurkeyMarc SchwartzMark J TullmanHoward Zwibel
Credits/Source: BMC Neurology 2014, 14:49

Source: 7thSpace Interactive © 2014 7thSpace Interactive (14/03/14)>

UK multiple sclerosis risk-sharing scheme: a new natural history dataset and an improved Markov model(20/01/14)


Objectives: In 2002, the UK's National Institute for Health and Care Excellence concluded that the multiple sclerosis (MS) disease modifying therapies; interferon-β and glatiramer acetate, were not cost effective over the short term but recognised that reducing disability over the longer term might dramatically improve the cost effectiveness. The UK Risk-sharing Scheme (RSS) was established to ensure cost-effective provision by prospectively collecting disability-related data from UK-treated patients with MS and comparing findings to a natural history (untreated) cohort. However, deficiencies were found in the originally selected untreated cohort and the resulting analytical approach. This study aims to identify a more suitable natural history cohort and to develop a robust analytical approach using the new cohort.

Design: The Scientific Advisory Group, recommended the British Columbia Multiple Sclerosis (BCMS) database, Canada, as providing a more suitable natural history comparator cohort. Transition probabilities were derived and different Markov models (discrete and continuous) with and without baseline covariates were applied.

Setting: MS clinics in Canada and the UK.

Participants: From the BCMS database, 898 ‘untreated’ patients with MS considered eligible for drug treatment based on the UK's Association of British Neurologists criteria.

Outcome measure: The predicted Expanded Disability Status Scale (EDSS) score was collected and assessed for goodness of fit when compared with actual outcome.

Results: The BCMS untreated cohort contributed 7335 EDSS scores over a median 6.4?years (6357 EDSS ‘transitions’ recorded at consecutive visits) during the period 1980–1995. A continuous Markov model with ‘onset age’ as a binary covariate was deemed the most suitable model for future RSS analysis.

Conclusions: A new untreated MS cohort from British Columbia has been selected and will be modelled using a continuous Markov model with onset age as a baseline covariate. This approach will now be applied to the treated UK RSS MS cohort for future price adjustment calculations.

Jacqueline Palace, Thomas Bregenzer, Helen Tremlett, Joel Oger, Fheng Zhu, Mike Boggild, Martin Duddy, Charles Dobson

Full Article

Source: BMJ Open Copyright © 2014 by the BMJ Publishing Group Ltd (20/01/14)

Early, steady MS treatment cuts progression risk(03/10/13)

Patients who received early and consistent disease modifying treatment at the first signs of multiple sclerosis – often called clinically isolated syndrome (CIS) – appeared to have a slower progression to disability than patients who were treated mainly for additional MS exacerbations, researchers reported here.

Over a 12-month period, patients treated 50% to 80% of the time following the first CIS event reduced their risk of progression -- as measured by the Expanded Disability Status Scale score -- by 45% compared with patients who received disease-modifying treatments less than 50% of the time or not at all (95% CI 0.39-0.79, P=0.001), and patients treated for more than 80% of the time following diagnosis reduced their risk of disability progression by 68% (95% CI 0.22-0.49, P<0.001), said Vilija Jokubaitis. PhD, post-doctoral fellow in neuroimmunology at the University of Melbourne.

"What was very interesting about this finding was that the patients who appeared to be worse after their CIS and MRI evaluation and who were treated early, did better than patients whose treatment was delayed," she said in her oral Young Investigators report at the annual meeting of the European Association for the Treatment and Research In Multiple Sclerosis.

About three-fourths of these patients were classified on the basis of T2 lesion enhancement as having relapsing-remitting multiple sclerosis at first treatment. Jokubaitis suggested that because their initial examinations looked worse, the patients were treated more aggressively, and that appeared to have long-term benefits in preventing progression.

"Study after study has shown that early treatment with disease-modifying drugs benefits patients with CIS," said Margaret Burnett, MD, assistant clinical professor of neurology and pathology at the University of Southern California in Los Angeles.

"It kills me that some places still are not treating CIS," she told MedPage Today. "These findings presented here are corroborating evidence that we should be treating CIS and we should make every effort to provide continuous treatment."

In the study, Jokubaitis and colleagues reviewed data involving 1,989 patients for whom complete records were available. The patients had a combined 6,724 years of follow-up with a median follow-up of 3 years per patient – ranging from 9 months to 9.9 years.

Of those patients, 1,339 were treated with disease-modifying agents, either interferon-based products or glatiramer acetate (Copaxone). The researchers included 307 patients who had sustained disability progression over 12 months.

The goal of the study was to determine predictors of progression, and the investigators found that advancing age was a weak prognosticator of disability progression – a 17% increased risk per decade (P=0.006). They also found that pyramidal system dysfunction was a strong predictor of disability progression – with higher imaging pathology translating to a 46% increased risk of disease progression (P=0.008).

Jokubaitis acknowledged that teasing out how treatment affected outcomes was confounded by the fact that sicker patients at diagnosis were more likely to be treated early and consistently, which helped them avoid disease progression.

She and her colleagues did scrutinize the different disease-modifying agents used in the study, but found all of them were successful in delaying progression and none appeared significantly better than the other, although treatment with glatiramer acetate approached significance compared with interferon-beta 1a intramuscular injection (P=0.052) in an ad-hoc analysis.

"Cumulative disease-modifying treatment duration significantly delays progression of multiple sclerosis," Jokubaitis said.

Co-Author Marie Trojano, MD, professor of neurology at the University of Bari in Italy, and president of ECTRIMS, told MedPage Today that concerns that clinically isolated syndromes might not be true multiple sclerosis should be discarded. "There really should not be a disease called CIS. Imaging scans can tell us these events are early multiple sclerosis."

Jokubaitis disclosed commercial interests with Novartis. Co-authors disclosed commercial interests with Biogen Idec, Bayer-Schering, sanofi, Merck-Serono, Teva, Genzyme, Roche, EMD-Serono, GSK and Biologix.

Trojano disclosed commercial interests with Biogen-Idec, Bayer-Schering, sanofi, Merck-Serono, Teva and Novartis.

Burnett had no disclosures.

Primary source: European Committee for Treatment and Research in Multiple Sclerosis Source reference: Jokubaitis V et al, "Predictors of 12-month confirmed disability progression after onset of clinically isolated syndrome (CIS) suggestive of multiple sclerosis" ECTRIMS 2013; Abstract 59.

Source: Medpage Today © 2013 MedPage Today, LLC (03/10/13)




Ampyra (Fampyra)

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Emerging Therapies


Lemtrada (Alemtuzumab)

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Trimesta (Oral Estriol)


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