MS news and research
This page documents breaking multiple sclerosis news and research stories as they occur during the month.
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Google, expanding its foray into medical research, will join Biogen Idec, maker of MS drugs, to study environmental and biological contributors to the condition’s progression.
The collaboration is the second major pharmaceutical partnership for the life science division of Google X labs, which has produced Google Glass and self-driving cars. Google X sees itself as providing the technical and innovative fire power for a “moonshot” in the health care field, said head of the division Andrew Conrad.
“Our central thesis is to change health care from being reactive to proactive,” Mr Conrad said. “We’re trying to understand condition at its onset and see if we can intervene early.”
Using sensors, software and data analysis tools, the companies will collect and sift through data from people with MS. The goal is to explain why the disease progresses differently from patient to patient, said Rick Rudick, Biogen’s vice president of development sciences.
“We used to see patients at the beginning stages of MS — two women would come in with optic neuritis, they couldn’t see out of one eye, they’d have some spots on the MRI scan, and they looked very similar,” said Rudick, who was previously director of the Cleveland Clinic’s MS program. “But as we followed them along, 10 years later, one would be a championship tennis player still and one would be in a nursing home. I never understood that.”
Biogen leads the market with five MS drugs and is using new technology to gather round-the-clock data on patients. It has run a Fitbit study to see whether fitness bands could be reliable data-gathering tools, and is developing an iPad app with the Cleveland Clinic to help physicians better assess their patients’ MS progression.
While Rudick and Conrad declined to comment on the terms of the deal, Conrad said it would probably be a multi-year effort.
MS affects 2.3 million people worldwide, according to America’s National Multiple Sclerosis Society. It causes the immune system to attack myelin, a fatty substance that coats and protects nerve fibers. Patients can experience tingling, problems with walking and degrading vision. Their symptoms get worse as MS progresses.
There are no approved cures, only drugs that help suppress the immune system or manage symptoms. Patients typically see their doctors a few times a year, meaning their day-to-day experiences aren’t catalogued.
More data may help Biogen develop more-effective drugs, or better understand which drugs should go to which patients. The experience of patients could also help Biogen prove the value of its medicine to insurers and pharmacy benefit managers, which are cracking down on high-priced drugs. MS treatments typically have wholesale prices of $50,000 a year.
After Chief Executive Officer George Scangos ran into Conrad at a digital health conference, according to Conrad. Scangos saw the opportunity to combine the search giant’s technical savvy with Biogen’s knowledge about MS.
“They bring great expertise in data analytics and technology, they’re sophisticated in their approach, they understand biology,” Scangos said, listing reasons why Biogen turned to Google instead of an academic partner.
The collaboration also deepens Google’s commitment to the health industry. Google X ventured into health care in January 2014 with the announcement of a smart contact-lens project.
The lens, developed to measure glucose in diabetes patients’ tears, was licensed by Novartis AG in July. Google X also bought health-tech startup Lift Labs, which makes cutlery that could counteract tremors experienced by people with Parkinson’s.
Conrad has 150 scientists working for him, including astrophysicists, theoretical mathematicians, oncologists, immunologists, electrical engineers and computer scientists.
“What I think and hope we’re good at,” he said, “is trying to do this moonshot, innovative thinking, where it’s OK to fail, and we’re looking for partners to join in these endeavours.”
Source: SFGate (28/01/15)
A study from a team of researchers at the Kessler Foundation provides new findings on multiple sclerosis (MS). According to the study, published in the journal Frontiers in Neurology, cognitive fatigue exhibited by MS patients is related to the length of the task they are involved in.
Fatigue is one of the most reported symptoms of Multiple Sclerosis (MS) with a prevalence estimation ranging from 70 to 90%. Cognitive fatigue can be a result of both cognitive and physical exertion, and usually presents as subjective sensations or objective changes in performance, fatigue, and fatigability.
Treating cognitive fatigue clinically is complicated because there is a poor understanding of the factors contributing to this combination of symptoms.
In their study titled “Subjective cognitive fatigue in MS depends on task length,” Joshua Sandry from the Neuropsychology and Neuroscience Research, Kessler Foundation, and colleagues examined the relationships between subjective and objective cognitive fatigue, information processing domain (PS), working memory (WM) cognitive load and time on a task in 32 patients with Multiple Sclerosis (MS). The results were compared with 24 healthy controls.
Data analysis showed that subjective cognitive fatigue was higher for the PS task, increased across time, and was higher in the MS group compared to healthy controls. Furthermore, the results revealed that subjective and objective fatigue were independent variables. Morevoer, subjective cognitive fatigue increased with the length of time spent on a task, strongly suggesting that cognitive fatigue in MS is a function of time.
The researchers indicate that this new understanding may help to inform future research studies and help clinicians conduct evaluations of cognitive fatigue in MS. This can ultimately lead to better treatment strategies to cognitive fatigue in Multiple Sclerosis.
Concerning these results, lead author Dr. Joshua Sandry said in a recent press release, “In our study, task length was the factor associated with subjective cognitive fatigue,” “which supports the hypothesis of Temporal Fatigue. This finding should be considered when designing cognitive studies in MS populations. More research is needed to look at these parameters in people with different types of MS, different levels of cognitive impairment and in more advanced stages.”
Source: Multiple Sclerosis News Today © BioNews-tx.com 2015 (23/01/15)
L Tromba, S Blasi, A Vestri, D Kiltzanidi, F Tartaglia, A Redler
Objectives: To verify the prevalence of chronic cerebrospinal venous insufficiency in patients affected by different clinical forms of multiple sclerosis and in healthy subjects using the Zamboni ultrasound protocol combined with M-mode ultrasound examination.
Materials and methods: We enrolled 112 patients with multiple sclerosis and 67 healthy subjects from 20 to 67 years of age. All the patients underwent Duplex and color-Doppler sonography of the neck vessels, transcranial colour duplex sonography, M-mode study of the valve system and of venous abnormalities. Subjects were positive for chronic cerebrospinal venous insufficiency when at least two of five hemodynamic criteria of the Zamboni protocol were fulfilled. Chronic cerebrospinal venous insufficiency condition was further analyzed by a multivariate analysis including age, sex, disease duration, subtypes of multiple sclerosis and expanded disability status scale score as independent variables.
Results: No healthy subjects was positive for chronic cerebrospinal venous insufficiency, while in the sample of patients affected by multiple sclerosis the diagnosis was made in 59.8% of cases (p < 0.0001). The first criterion was the most frequent in patients affected by multiple sclerosis and chronic cerebrospinal venous insufficiency (respectively 54.4% and 76.1%, p < 0.001). The second, third and fourth criteria were never present in healthy subjects but were detected in patients with multiple sclerosis. The positivity of the second criterion was associated with diagnosis of chronic cerebrospinal venous insufficiency in 100% of cases. The third criterion had a prevalence of 52.2% in the subgroup of chronic cerebrospinal venous insufficiency patients. It was positive in 36 multiple sclerosis patients and was associated with chronic cerebrospinal venous insufficiency diagnosis in all cases except one. The multivariate analysis showed that age, disease duration, sex, subtypes of multiple sclerosis and expanded disability status scale score were not considered predictors of this haemodynamic condition.
Conclusion: Chronic cerebrospinal venous insufficiency is a haemodynamic condition strongly associated with multiple sclerosis and is not found in normal controls. The addition of M-mode ultrasound to the diagnostic protocol allows improved observation of venous valve abnormalities.
Source: Phlebology: The Journal of Venous Disease © 2015 by SAGE Publications (23/01/15)
Biopharmaceutical company Receptos, Inc. has enrolled the first participant with relapsing multiple sclerosis (RMS) in its SUNBEAM phase 3 trial, which will evaluate the potential therapy RPC1063 in patients who have the multiple sclerosis. The company’s phase 3 RADIANCE trial, also involving RMS patients, had already been initiated, which means that Receptos may be able to finish its clinical development program for multiple sclerosis by 2017, according to the company’s press release.
RPC1063 is a novel, oral, once daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator being developed by Receptos for the treatment of autoimmune indications such as RMS, but also ulcerative colitis (UC) as well. “Our initiation of the SUNBEAM trial represents another major corporate milestone for Receptos, and positions RPC1063 as the potential next-to-market oral agent for the treatment of relapsing multiple sclerosis,” said the president and chief executive officer of Receptos, Faheem Hasnain.
Both the SUNBEAM and RADIANCE trials are randomised, double-blind studies that will include 1,200 RMS patients, and are designed to compare 0.5 mg and 1.0 mg doses of RPC1063 with interferon beta-1a (Avonex). In addition, the trials aim to evaluate RPC1063’s superiority in comparison with Avonex regarding the decrease of the annualised relapse rate following either one or two years of therapy. Both of the phase 3 trials are taking place under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
The RPC1063 therapy had already been demonstrated to be promising for treatment of MS, as it met the primary endpoint of reduction in MRI brain lesion activity and secondary endpoints measuring effects of other MRI parameters in its phase 2 trials, which were announced last summer. In addition, researchers were also able to trace a consistent safety profile. Receptos presented the findings at the largest meeting dedicated to MS to date, the joint meeting of the Americas Committee for Treatment and Research In Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS).
“Following our recent positive Phase 2 results in ulcerative colitis, we also plan to initiate a Phase 3 program for RPC1063 in inflammatory bowel disease in 2015. We believe that this drug candidate represents a potential franchise in immunology, and we continue to explore opportunities in other therapeutic indications where there is strong scientific rationale,” added the president and CEO of Receptos.
After having announced that they were looking for RMS patients for the SUNBEAM and RADIANCE trials at the end of last year, the company is also going to assess the RPC1063 therapy in inflammatory bowel disease (IBD) patients in its TOUCHSTONE phase 3 trial, which includes patients who suffer from UC, and a phase 2 trial in patients with Crohn’s disease. Both of the trials are scheduled to begin this year, and are based on the encouraging results obtained by the company in its prior studies of the medication with IBD.
Source: Multiple Sclerosis News Today © BioNews-tx.com 2015 (21/01/15)
A therapy that uses patients' own primitive blood cells may be able to reverse some of the effects of multiple sclerosis, a preliminary study suggests.
The findings, published Tuesday in the Journal of the American Medical Association, had experts cautiously optimistic.
But they also stressed that the study was small -- with around 150 patients -- and the benefits were limited to people who were in the earlier courses of multiple sclerosis (MS).
"This is certainly a positive development," said Bruce Bebo, the executive vice president of research for the National Multiple Sclerosis Society.
There are numerous so-called "disease-modifying" drugs available to treat MS -- a disease in which the immune system mistakenly attacks the protective sheath (called myelin) around fibres in the brain and spine, according to the society. Depending on where the damage is, symptoms include muscle weakness, numbness, vision problems and difficulty with balance and coordination.
But while those drugs can slow the progression of MS, they can't reverse disability, said Dr. Richard Burt, the lead researcher on the new study and chief of immunotherapy and autoimmune diseases at Northwestern University's Feinberg School of Medicine in Chicago.
His team tested a new approach: essentially, "rebooting" the immune system with patients' own blood-forming stem cells -- primitive cells that mature into immune-system fighters.
The researchers removed and stored stem cells from MS patients' blood, then used relatively low-dose chemotherapy drugs to -- as Burt described it -- "turn down" the patients' immune-system activity.
From there, the stem cells were infused back into patients' blood.
Just over 80 people were followed for two years after they had the procedure, according to the study. Half saw their score on a standard MS disability scale fall by one point or more, according to Burt's team. Of 36 patients who were followed for four years, nearly two-thirds saw that much of an improvement.
Bebo said a one-point change on that scale -- called the Expanded Disability Status Scale -- is meaningful. "It would definitely improve patients' quality of life," he noted.
What's more, of the patients followed for four years, 80 percent remained free of a symptom flare-up.
There are caveats, though. One is that the therapy was only effective for patients with relapsing-remitting MS -- where symptoms flare up, then improve or disappear for a period of time. It was not helpful for the 27 patients with secondary-progressive MS, or those who'd had any form of MS for more than 10 years. Secondary-progressive MS occurs when the disease progresses more steadily and people no longer go through waves of symptoms and recovery.
Between 250,000 and 350,000 Americans have MS, according to the National Institutes of Health (NIH). Most are initially diagnosed with the relapsing-remitting form. Eventually, relapsing-remitting MS transitions to the secondary-progressive form.
It makes sense that stem cell therapy would be effective only in the relapsing-remitting stage, according to Bebo. That's the phase where the immune system is actively attacking the myelin.
Burt agreed, noting that once people are in the secondary-progressive stage, the damage to nerves is done.
A big question is what will the long-range effects will be, according to an editorial published with the study.
MS usually arises between the ages of 20 and 40, according to the NIH. Since disabilities can take decades to develop, the ultimate benefits -- and risks -- of stem cell therapy remain unknown, writes Dr. Stephen Hauser, a neurologist at the University of California, San Francisco.
It's also unclear, Hauser writes, whether the therapy is really "resetting" the immune system.
Bebo agreed. "In this report," he said, "there's no data to show whether that's happening."
What's needed now, Bebo said, are controlled trials where patients are randomly assigned to receive stem cell therapy.
Burt agreed, and said that's what his team is doing: A clinical trial is underway at several medical centers, looking at patients with relapsing-remitting MS whose symptoms have failed to improve after at least six months on standard medications. They're being randomly assigned to either stem cell therapy or further drug therapy.
If stem cell therapy does prove effective, it's hard to say exactly how it will fit in with standard MS care, according to Bebo.
On one hand, the regimen is fairly intensive and expensive. "But in theory," Bebo said, "it would only have to be done once, and never again."
The disease-modifying drugs for MS -- such as beta interferons (Avonex, Rebif, Betaferon), glatirimer (Copaxone) and natalizumab (Tysabri) -- can cost thousands per month, according to the background information in the study.
Comparatively, stem cell therapy, at around $125,000, could prove very cost-effective, according to Burt.
For now, stem cell therapy is available only in clinical trials, or on a "compassionate use" basis for some patients who don't qualify for a trial, Burt said.
If it's eventually approved as an MS therapy, Burt said he foresees stem cells as a "second-line" therapy for patients who do not fare well on a disease-modifying drug.
Source: NEWSMAXHEALTH.COM © 2015 Newsmax Media, Inc (21/01/15)
Following on the heels of a Cochrane meta-analysis earlier in 2014, a new study finds that MS patients followed over 10 years have similar annualised relapse rates whether they take glatiramer acetate or one of the interferon betas.
No matter how you slice it, glatiramer acetate (GA) and the interferon betas (IFN-β) appear to be equally good treatment options for patients with relapsing-remitting multiple sclerosis (RRMS). A recent study from the Multiple Sclerosis Journal looked at 10 years of data on over 3,000 RRMS patients registered in MSBase, a global database of MS patients, and found that GA and IFN-β were similarly successful in reducing relapses (Kalincik et al., 2014). The study’s conclusions are similar to, though slightly different from, those of a Cochrane meta-analysis published in the summer of 2014 (La Mantia et al., 2014).
In the new study, researchers pulled data from MSBase on 3,326 RRMS patients who were using either IFN-β or GA as their first-ever disease-modifying therapy (DMT) for at least 6 months, and had started treatment within 10 years of their first symptom. To be included in the study, patients also had to have had at least one relapse recorded during the two years leading up to the start of their initial DMT. Each patient also had to have a minimal data set recording sex, age, date of first MS symptoms, dates of relapses, clinical MS score, their treatment center, and their baseline disability described by the Expanded Disability Status Scale.
The researchers looked at patients in four different treatment groups: IFN-β-1a intramuscular (IM), IFN-β-1a subcutaneous (SC), IFN-β-1b, and GA. They noted that, generally, patients treated with IFN-β-1a IM were less disabled at baseline than patients treated with the other interferons. Patients on GA were also generally older than patients on interferons. The researchers then paired each treatment group in six different head-to-head comparisons. The patients were also matched in clinical and demographic characteristics in each comparison.
For all treatments, the average annualised relapse rate (ARR) ranged from 0.38 to 0.56 relapses per year. The researchers noted that patients in the GA and IFN-β-1a SC groups had the lowest average ARR, with a relatively small range (0.15–0.16 relapses per year for GA and 0.09–0.1 relapses per year for IFN-β-1a SC).
Additionally, approximately one-third to one-half of all relapses were treated with steroids, and the researchers saw no significant differences in the efficacy of steroid treatment between the groups. The researchers also observed a significantly higher portion of relapse-free patients in the GA group compared to the IFN-β-1a IM and IFN-β-1b groups (p ≤ 0.02).
These findings match up with those of the Cochrane meta-analysis, which looked at a number of clinical outcomes, including relapse rate. In the Cochrane meta-analysis, the researchers found that in one head-to-head trial, patients on GA had a slightly better outcome in relapse rates at a 3-year follow-up. The Cochrane meta-analysis also found a number of small but significant variations in other outcome measures such as MRI data, but the new study did not look at the same outcomes.
The conclusions of both studies were that, by and large, GA and the IFN-βs are relatively similar in clinical outcome. None of the treatments showed major differences in accrued disability over time. It appears that GA and IFN-β-1a SC may be slightly superior in lowering ARR, but the data for all treatments are relatively limited.
The authors of the current study noted that they are “eagerly awaiting” similar reviews on newer treatment options.
Source: Multiple Sclerosis Discovery Forum © 2015 MGH and ACP (21/01/15)
The Supreme Court has sided with Teva Pharmaceutical Industries Ltd. in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug.
The justices ruled Tuesday that a federal appeals court wrongly overturned five of Teva's patents for the drug Copaxone. The decision allows the Israel-based company to keep its exclusive rights to the drug until September 2015.
Copaxone generates about $4 billion in annual sales for Teva.
Teva had argued that the U.S. Court of Appeals for the Federal Circuit should not have second-guessed factual findings made by a federal district court that had earlier ruled in Teva's favour.
The justices agreed that the Federal Circuit should have deferred to factual findings made by the lower court.
Source: Star Tribune National © 2015 StarTribune (20/01/15)
A common gut microbe might curb the risk of developing multiple sclerosis—at least in women—suggests the largest study of its kind published online in the Journal of Neurology Neurosurgery & Psychiatry.
If confirmed in other studies, this might prove the hygiene hypothesis, the premise of which is that childhood infections help to prime and regulate the immune system and ward off autoimmune and allergic diseases in later life, say the researchers.
The prevalence of multiple sclerosis (MS) has increased worldwide, in tandem with other autoimmune disease, but the reasons behind this rise are unclear. Some studies have suggested a link between early childhood infection and reduced MS risk, but they have all been small.
The researchers therefore tested 550 people with confirmed MS and a comparison group of 299 healthy people, matched for age and sex, for the presence of antibodies to Helicobacter pylori. The tests were done between 2007 and 2011.
H. pylori is usually acquired before the age of 2, and lasts for life in the stomach, unless treated. Around half the world's population is infected with it, most of whom live in the developing world, where hygiene standards and antibiotic prescribing rates tend to be lower than they are in developed countries.
The results showed that the prevalence of the infection was significantly lower in those with MS than in the comparison group, but only among women, in whom it was around 30% lower.
Furthermore, after taking account of influential factors, such as age at diagnosis, year of birth, and duration of symptoms, those women with MS who tested positive for H. pylori seemed to be less disabled by their condition than those who tested negative for the infection.
The reverse was true in men, among whom a positive test result was linked to higher rates of disability.
There was no evidence of any link between the presence of the infection and relapse rate.
There's no obvious explanation for the gender disparity, which definitely warrants further study, say the researchers. Rates of MS are higher in women than they are in men, with most of the increased prevalence of MS in recent years, occurring in women.
In a linked editorial, Professor Jun-ichi Kira, of the Neurological Institute at Kyushu University, Fukuoka, Japan, points out that the lower disability scores reported by the women with MS who tested positive for H. pylori, suggests that the infection might be protective.
"Collectively, such an inverse correlation of H. pylori infection with MS in developing countries where MS and allergic disorders have increased, may support the 'hygiene hypothesis,' he writes.
"Although why the protective effects of H. pylori against MS were observed only in women remains to be elucidated, but might explain the recent increase in female to male ratio of MS in developed countries," he adds.
Source: Medical Xpress © Medical Xpress 2011-2014, Science X network (20/01/15)
MedDay, a biotechnology company that develops new drugs for nervous system disorders, announced an update on the progress of its development pipeline with its lead product MD1003 for the treatment of primary and secondary progressive multiple sclerosis (MS). The first study is expected to be complete in early 2015, while the second should be complete in late 2015.
The company aims to develop drugs for neurological and psychiatric diseases through brain metabolism and is currently developing a compound to target progressive MS, the ultra-orphan condition adrenoleukodystrophy (AMN), Alzheimer’s disease, and autism.
MedDay’s MD1003 for MS, which have been approved for patent protection in the US and Europe, is a highly concentrated formulation of D biotin (vitamin H), a key co-factor for enzymes involved in energy production and synthesis of myelin. The company announced that trials for drug use for the treatment of primary and secondary progressive multiple sclerosis, continue to progress well.
A pilot open label study that enrolled 23 patients with primary and primary and secondary progressive MS confirmed the efficacy of MD1003. The trial is expected to enroll the last patient this month, and results should be presented on 18 April 2015 during the American Academy of Neurology annual meeting. Furthermore, the company has two-phase 2b/3, placebo-controlled pivotal studies in progress at 21 MS centers in France and in the UK where 250 patients are enrolled.
MedDay’s second trial in MS patients with permanent visual loss after optic neuritis, called “MS-ON’, is expected to retrieve results during the second semester of 2015.
In a recent press release, Frédéric Sedel, Chief Executive Officer of MedDay said, “MedDay is making rapid progress in demonstrating the clinical viability of its unique approach to the development of treatments that target the nervous system’s metabolism. This approach and our expertise come from the study of rare inborn metabolic errors. We anticipate the completion of our first pivotal trial in primary and progressive MS, an area in which currently available MS treatments have little or no effect, later this month and we are on track to complete a second study this year.”
Moreover, in order to develop additional pipeline assests, the company developed a research platform called SPECMET in collaboration with Assistance Publique Hôpitaux de Paris (APHP) and the Commissariat à l’Energie Atomique et aux Energies Alternatives (CEA). SPECMET aims to identify new treatment targets through cerebrospinal fluid metabolomics analyses.
“Our metabolomics platform, SPECMET, continues to identify specific metabolic signatures in major central nervous system disorders, providing numerous opportunities for further pipeline developments. By focusing on compounds that already have known activity in neurological metabolic pathways, we believe we can quickly demonstrate clinical proof of concept.”, Sedel said in the press release.
Source: Multiple Sclerosis News Today © BioNews-tx.com 2015 (19/01/15)
Trishna, regular writer for MS-UK magazine New Pathways, joins The People’s Strictly for Comic Relief (19/01/15)
The BBC has announced six ‘inspirational but everyday heroes and heroines’ are to take part in The People’s Strictly for Comic Relief.
Hosted by Tess Daley and Claudia Winkleman, the four-part series will follow the journey of six people as they take part in their own Strictly experience and perform in the famous Strictly Come Dancing ballroom.
Among the six is one Trishna Bharadia, well known to regular readers of New Pathways.
She said: ‘I'm super excited to be taking part in this. I'm a big fan of Strictly and love dancing around the house and going to Zumba. When I found out about it, it was a huge shock, as I didn't know my sister had nominated me! I'm really looking forward to being part of the whole Strictly experience. It's going to be a great way to put MS on the map and raise awareness about the condition to a wider audience. I hope more people will start to gain an understanding of the condition through the show. Plus it's all for a good cause.’
Trishna was diagnosed with relapsing remitting MS in 2008, then aged 28. Symptoms including loss of strength in both hands, loss of feeling down her left side, pins and needles and the MS hug had started three years previously.
She said: ‘I've been on Rebif and Copaxone but failed both so I'm not on any medication for my MS. I also developed Chronic Urticaria (hives) last year, possibly as a side effect of Copaxone, so that's been another issue I've had to deal with as it's another autoimmune condition.
‘My current overriding symptom is fatigue so my life has become a huge juggling act, considering I work full-time, go to Zumba a few times a week, play hockey and I'm involved in at least five or six MS organisations and charities. I've been particularly vocal about raising awareness about MS in the Asian community and helping younger people with the condition, particularly because being diagnosed in either of those communities can result in stigmatisation and isolation.’
Follow Trishna’s progress on Twitter @TrishnaBharadia
Visit Trishna’s Instagram at TrishnaBharadia
Connect with Tristna on Facebook at facebook.com/trishnabharadia2015
Source: MS-UK (19/01/15)
A 17-year longitudinal study published online ahead of print in the Multiple Sclerosis Journal found that corpus callosum area (CCA) was closely associated with cognitive decline in multiple sclerosis patients (Granberg et al., 2014). The results may point to a refreshingly uncomplicated biomarker for cognitive and physical disability in MS patients.
The researchers examined a cohort of 37 MS patients in 1996, with follow-up examinations in 2004 and 2013, to assess changes in their CCA. In order to compare CCA from patient to patient, the researchers normalised each patient’s midsagittal CCA to his or her midsagittal intracranial skull surface area. They called the resulting measurement the normalized corpus callosum area (nCCA).
In the 2004 and 2013 follow-ups, only 23 of the patients remained in the study, and the researchers compared their results with those of 23 age- and sex-matched healthy controls. At each examination the participants were assessed on the Expanded Disability Status Scale (EDSS) and they performed the Symbol Digit Modalities Test (SDMT), a measurement of processing speed.
Overall, nCCA correlated well with SDMT and EDSS scores in patients (r = 0.793, p < 0.001; r = −0.545, p < 0.001, respectively) after adjusting for disease duration, age, and sex and also adjusting for multiple comparisons. These correlations outperformed other measures of brain atrophy such as gray matter fraction and normalised lesion volume.
“I wouldn’t have expected that the simple measurements of the corpus callosum would actually outperform the volumetric measurements,” Tobias Granberg, M.D., who is a current Ph.D. candidate at Karolinska Institutet in Stockholm, Sweden, told MSDF. He said that it takes only about 45 seconds to obtain the measurement from each MRI sequence.
Although the nCCA measurements showed a strong correlation with patients’ SDMT and EDSS scores at each time point, the nCCA measurements taken in 1996 were not predictive of each patient's SDMT and EDSS scores 17 years later. Granberg and his colleagues adjusted the patients’ nCCA with their SDMT and EDSS scores at the outset and found no statistically significant relationship between nCCA and SDMT or EDSS in 2013. Granberg told MSDF that he felt the lack of statistical significance was due to the small sample size, and that future studies with larger sample sizes would show greater predictive power of nCCA.
“There are some previous studies that have used these simple measurements and have proven that they can help in deciding which patients will be going from having clinically isolated syndrome into having MS,” Granberg said.
Granberg also said that he and his colleagues are conducting a companion study to this one directly comparing corpus callosum area to the corpus callosum index, another method of measuring atrophy. He’s also testing nCCA as a way to potentially differentiate patients in the relapsing versus the progressive phase of the disease.
Corpus callosum atrophy is strongly associated with cognitive impairment in multiple sclerosis: Results of a 17-year longitudinal study. Granberg T, Martola J, Bergendal G, Shams S, Damangir S, Aspelin P, Fredrikson S, Kristoffersen-Wiberg M Mult Scler. 2014 Dec 5. PMID: 25480866. Abstract
Source: Multiple Sclerosis Discovery Forum Copyright © 2014 MGH and ACP (19/01/15)
Arena Pharmaceuticals, Inc. released the first results from its phase 1b trial that for the evaluation of an oral drug candidate called APD334 for the treatment of autoimmune diseases, such as multiple sclerosis (MS). The multiple ascending dose clinical trial demonstrated encouraging findings about the drug, which is designed to target the sphingosine 1-phosphate subtype 1 (S1P1) receptor.
The scientists analyzing the drug observed a dose-dependent effect on lymphocyte count lowering in blood, with mean decreases from baseline of up to 69%, due to APD334, within the phase 1b, as announced by the company in a press release. On average, lymphocyte was registered as recovered to baseline a week after the conclusion of dosing.
“Lymphocyte lowering at the level demonstrated in this trial has been shown to correlate with clinical efficacy in Phase 2 and Phase 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis,” explained the Senior Vice President and Chief Medical Officer of Arena, William R. Shanahan, M.D. “The results of this trial support investigation of the efficacy and safety of APD334 in patients with autoimmune diseases.
In addition, no significant safety findings worth noting regarding heart rate or rhythm, pulmonary function, or elevations in liver enzymes were registered. The adverse events related to the treatment most commonly noted were mild or moderate contact dermatitis, headache, constipation and diarrhea, despite the fact that none of them were clearly attributed to the drug, and there were no discontinuations for adverse events nor serious adverse events observed.
The purpose of the randomized, double-blind, placebo-controlled phase 1b clinical trial was to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple-ascending doses of APD334. The study was conducted in five different dosing cohorts, which comprised a total of 50 healthy participants, who were administrated with APD334, as well as 10 other who received placebo during a 21-day period.
“Based on these impressive results, we plan to expedite APD334 into Phase 2 clinical trials for ulcerative colitis and Crohn’s disease,” stated Jack Lief, Arena’s President and Chief Executive Officer. “The advancement of this promising drug candidate further demonstrates Arena’s focused expertise in discovering and developing innovative drug candidates targeting G protein-coupled receptors that have the potential to improve health,” he added.
Source: Multiple Sclerosis News Today © BioNews-tx.com 2015 (16/01/15)
Semaphorin 4D (SEMA4D) is a viable target for therapy in neuroinflammatory and neurodegenerative diseases like multiple sclerosis (MS), according to findings published in Neurobiology of Disease.
Researchers from Vaccinex, Inc. in Rochester, New York conducted a study of mouse models of experimental autoimmune encephalomyelitis (EAE) – a surrogate for human MS – in order to determine if SEMA4D or any specific novel molecular therapy would make a viable target. The investigators created a monoclonal antibody which binds animal model SEMA4D with high affinity and inhibits the binding between SEMA4D and its receptors. In the process, anti SEMA4D binds in vitro to the recombinant SEMA4D, which prohibited the survival and differentiation of oligodendrocytes precursor cells (OPCs) – important for maintaining the myelin coating on neurons. The EAE rodents demonstrated anti SEMA4D significantly inhibited the development of the neurodegenerative diseases by preserving the BBB integrity and axonal myelination.
A further result the researchers noted was that anti SEMA4D tended to aid the migration of OPC to the site of lesions and improved myelin status after inducing demyelination chemically.
The researchers found that in 3 causes of neuroinflammatory disease, which included the breakdown of the brain blood barrier (BBB), apoptosis of OPCs, and activation of microglia, SEMA4D was effective in blocking the activity. Antibodies were vital to this blocking process, the researchers found.
Vaccinex is currently testing an antibody that blocks human SEMA4D called VX15/2503 in a phase 1 clinical trial. That study is designed to test the safety and tolerability in human patients with MS. The results of this study are expected to be available in early 2015. Vaccinex is a clinical stage biotechnology company which focuses on the discovery and development of human therapeutic monoclonal antibodies to treat cancer and neurodegenerative diseases such as MS and Huntington’s disease.
Source: HCP Live © HCP Live 2015 (14/01/15)
MedDay has provided an update on the progress of its lead product MD1003 for the treatment of primary and secondary progressive multiple sclerosis (MS), which is expected to complete its first pivotal study in Q1 2015. A second pivotal study is on track for completion by the end of 2015.
Development of MedDay’s lead candidate, MD1003, for the treatment of primary and secondary progressive multiple sclerosis, continues to progress well. Progressive MS is an area of significant unmet need. MD1003 is a highly concentrated formulation of D biotin (vitamin H). Patents protecting the dose and use in multiple sclerosis (MS) as an active pharmaceutical ingredient have been approved in the US and Europe, offering protection until 2032. Biotin is a key co-factor for enzymes involved in energy production and synthesis of myelin.
Proof of concept has been obtained in a pilot open label study involving 23 subjects with primary and secondary progressive MS. Two phase 2b/3, placebo-controlled, pivotal studies are ongoing, involving 250 patients and 21 MS reference centers in France and the UK. The placebo-controlled phase of the first registration trial MS-SPI is almost complete. The last patient visit is expected in mid-January 2015 and we aim to present the results at the American Academy of Neurology annual meeting on 18 April 2015.
Results of the second registration trial in MS, “MS-ON”, dedicated to patients with permanent visual loss following optic neuritis, are expected in H2 2015.
Source: MedDay (14/01/15)
The SMC has accepted peginterferon-beta-1a for use in adult patients for the treatment of relapsing remitting multiple sclerosis because the balance of costs and benefits mean that it offers value for money.
What is peginterferon-beta-1a used for?
Peginterferon-beta-1a is a treatment for relapsing remitting multiple sclerosis (RRMS). Multiple sclerosis (MS) is a chronic debilitating disease in which the protective coating (called myelin) on nerve fibres within the central nervous system becomes inflamed and is then destroyed by the immune system. Patients with MS often experience muscle weakness and difficulty with coordination and balance. RRMS occurs in 80% of people at onset and is characterised by periods of good health followed by sudden relapses. The aim of treatment is to reduce the frequency and severity of relapses, reduce lesions, slow down physical disability and maintain and improve quality of life.
How does it work?
Peginterferon-beta-1a is the first pegylated form of beta-interferon 1a. Interferons are a group of proteins that form part of the immune system called cytokines. Beta-interferon 1a helps to reduce the inflammatory processes that attack the myelin coating on nerve fibres. The interferon beta-1a is attached to a large molecule to produce pegylated interferon beta-1a and this helps to slow down the rate at which it is broken down in the body so it allows more constant levels of the drug in the body. It is given by injection under the skin every two weeks.
Source: Scottish Medicines Consortium (13/01/15)
Multiple Sclerosis (MS) patients are less able to regulate their emotions and have a poorer quality of life than people who don't have the disease, according to research carried out at the University of Aberdeen.
MS currently affects around 100,000 people in the UK and Scotland has one of the highest incidences of the disease in the world. While usually considered to be primarily a disease that affects movement, there are high instances of emotion disorders such as depression reported in people with MS.
Prof Louise Phillips, Chair in Psychology at the University of Aberdeen said, "We are interested in how MS contributes to difficulties in understanding and controlling your own emotions - known as emotion regulation. We already know that there are high levels of depression in MS and that MS affects brain networks that are potentially involved in emotion regulation. This study showed that people with MS had poorer emotion regulation ability than those who did not have MS. This is new information and helps us to understand the difficulties that people with MS face in their everyday life. Importantly, we found that those with MS and poor emotion regulation also scored lower on quality of life and social interaction measures. This is evidence of how emotion regulation difficulties in MS can impact on real-life situations."
This study funded by Tenovus Scotland and published recently in the Journal of Clinical and Experimental Neuropsychology involved asking people with MS to complete questionnaires about their ability to cope with their own emotions, how they generally feel and how often they socialise.
Currently, the symptoms of MS are managed by drug treatments that tackle the motor difficulties associated with the disease. This new study, however, paves the way for future interventions to include ways to improve emotion regulation.
Prof Phillips said, "The findings of this study suggest that additional treatments that focus on emotion difficulties such as cognitive behavioural therapy should be considered as part of the MS management programme. In doing so, this may help improve the quality of life of some people with MS. It is important to investigate emotion regulation and quality of life in order to understand the challenges that those with MS face when in everyday social situations. As well as having social implications, like increases in conflict, poor emotion regulation can impact more broadly on health and has been found to be associated with some heart problems."
Source: MedicalXpress © Medical Xpress 2011-2014, Science X network (13/01/15)
A better understanding of the pathological mechanisms that drive neurodegeneration in individuals with multiple sclerosis is needed to develop therapies that will effectively treat patients in the primary and secondary progressive stages of the disease. We propose that the inflammatory demyelinating disease process in early multiple sclerosis triggers a cascade of events that lead to neurodegeneration and are amplified by pathogenic mechanisms related to brain ageing and accumulated disease burden. Key elements driving neurodegeneration include microglia activation, chronic oxidative injury, accumulation of mitochondrial damage in axons, and age-related iron accumulation in the human brain. Altered mitochondrial function in axons might be of particular importance. This process leads to chronic cell stress and imbalance of ionic homoeostasis, resulting in axonal and neuronal death. The evidence suggests that treatment of progressive multiple sclerosis should be based on a combination of anti-inflammatory, regenerative, and neuroprotective strategies.
Source: The Lancet Neurology Copyright © 2015 Elsevier Limited (12/01/15)
Bionure, Inc. a California-based late-preclinical drug development company, today announced that it has entered into a Sponsored Research Agreement with the US National Multiple Sclerosis Society through Fast Forward, its commercial research subsidiary aimed at accelerating the development of new and improved therapies for MS. Under this agreement, Fast Forward will provide funding to Bionure for the late-preclinical development of BN201 to enable IND filling to support the Phase 1 clinical study in Acute Optic Neuritis (AON). Optic neuritis is often a first sign of multiple sclerosis.
Bionure’s BN201 is a New-Chemical Entity, first-in-class neuroprotective candidate in development for AON and has been recently granted with orphan designation status by the FDA. Beyond its neuroprotective activity in neurons, the compound has been shown to stimulate remyelination by differentiating OPCs into mature oligodendrocytes and promoting the formation of myelin sheaths around axons. Protecting the nervous system from damage and reversing that damage through myelin repair has the potential to restore function to people with optic neuritis and multiple sclerosis.
“We are excited to collaborate with the National MS Society towards accelerating BN201 into clinical trials for AON”, said Mr. Albert G. Zamora, CEO at Bionure. "Fast Forward's support provides an independent scientific validation for Bionure’s BN201 potential to treat AON and MS through an innovative approach and will allow Bionure to file the IND by Q2 of 2015”.
“The National MS Society is committed to helping people with MS live their best lives,” said Mark Allegretta, PhD, Associate Vice President of Commercial Research at the Society. “We are pleased to partner with Bionure to accelerate the development of its novel neuroprotective and remyelinating compound. Protecting and repairing the nervous system holds promise for people with progressive forms of MS, for whom there are so few treatment options.”
Source: Business Wire ©2015 Business Wire (12/01/15)
University of Edinburgh scientists are set to work with leading biotechnology company Genzyme, a Sanofi company, to carry out drug discovery research that could reduce neuron damage in the brain.
The collaboration - facilitated by Edinburgh BioQuarter's Business Development team - will focus on identifying therapeutic candidates capable of promoting remyelination and reducing neurodegeneration, mostly in relation to Multiple Sclerosis (MS).
MS is caused by damage to myelin, the protective layer that surrounds nerve fibres. This damage affects the transmission of electrical signals from the brain to the rest of the body and results in symptoms such as problems with muscle movement, balance and vision. Over time MS patients accrue disability, which usually slowly gets worse - this is related to neurodegeneration.
A natural process called 'remyelination' can repair damaged myelin and restore nerve function. In MS, however, remyelination is inefficient.
Scientists from the University of Edinburgh have discovered a physiologically-occurring molecule that prevents the cells needed to help repair damaged myelin from reaching the area of damage, which limits remyelination.
By working with Genzyme, co-investigators Dr Anna Williams, of the MRC Centre for Regenerative Medicine, and Dr Scott Webster hope to identify inhibitors of this molecule (or its receptor) to prevent this block and encourage the cells capable of repairing myelin into the area of damage.
Dr. Williams said: "If successful, this will be a step-change in MS treatment as current treatments are unable to repair the damaged neurons that cause the symptoms of MS.
"Ultimately this could reduce neurodegeneration in MS and the accumulation of disability in patients. This treatment could also be used in other diseases where myelin is damaged, such as spinal cord injury."
Dr. Johanne Kaplan, Vice President of Neuroimmunology Research at Genzyme, stated: "We are very much looking forward to a productive collaboration with Drs. Williams and Webster based on our combined expertise in remyelination and drug discovery and development. Remyelination-promoting therapies remain an unmet need and would be of great benefit to MS patients".
Source: MNT © MediLexicon International Ltd 2004-2015 (09/01/15)
Biogen Idec Inc’s experimental drug for multiple sclerosis showed signs that it could help repair nerve damage in patients’ eyes, a tentatively positive step for a drug aimed at reversing progression of the disease.
In a mid-stage trial of 82 patients, Biogen’s drug showed a 34 percent improvement in those who completed the study. The result fell a hair below the threshold for statistical significance. Including patients who didn’t complete the study, results were positive but didn’t reach statistical significance, Biogen said today in a statement.
Biogen climbed 2.2 percent to $361 in early trading. The company, based in Cambridge, Massachusetts, gets most of its revenue from multiple sclerosis drugs like Tecfidera and is pushing for new treatments for the disease, which affects 2.3 million people worldwide. There are no approved cures for multiple sclerosis, only drugs that help suppress the immune system or manage symptoms.
“This is a huge hope,” said Tim Coetzee, chief research officer at the National Multiple Sclerosis Society, in a telephone interview before Biogen’s news was released. “Rebuilding the nervous system is the next frontier of how we tackle treating MS, and for many people who live with MS, strategies like this are a source of hope that they could get some function back.”
Multiple sclerosis causes the immune system to attack myelin, a fatty substance that coats and protects nerve fibres. Patients can experience tingling, problems with walking and degrading vision. Their symptoms get worse as MS progresses.
Biogen’s drug, called BIIB033, targets a protein in the the central nervous system that regulates myelin production. The antibody could spur the myelin to regrow and reverse the progression of the disease.
Biogen’s mid-stage trial tested the drug’s effects on optic neuritis, inflammation of the optic nerve often caused by multiple sclerosis. Interpreting the data may not be clear cut, according to Eric Schmidt, an analyst at Cowen & Co.
“Optic neuritis is really just a ‘proof of biology’ indication for MS,” he said in an e-mail before Biogen’s announcement today. “We really don’t know how data from one indication will translate to the other.” More studies that directly measure its effects on multiple sclerosis are needed before any conclusions can be drawn, Schmidt said.
While patients in the trial generally tolerated the drug well, two patients had hypersensitivity reactions around the time the drug was infused, and one had an elevation in enzymes that can cause liver damage, which resolved itself when the patient stopped using the medicine.
Source: Bloomberg ©2015 Bloomberg L.P.(08/01/15)
Modifiable lifestyle factors contribute to depression in multiple sclerosis (MS) patients, according to a study published in BMC Psychiatry.
Researchers from St. Vincent's Hospital Melbourne in Victoria, Australia examined nearly 2,500 MS patients in order to understand the association between lifestyle risk factors, medication, and depression risk through the analysis of self reported data.
The researchers collected data about the participants' sociodemographics, diagnostic history, level of disability, comorbidities, fatigue, depression, body mass index (BMI), and an assortment of lifestyle and health behaviors. Patients were mainly female (82.4 percent) and middle aged (median age 45 years) and most patients (61.3 percent) had relapsing remitting MS. Most participants health either a bachelor (36.5 percent) or post graduate degrees (23.5 percent) and worked either full time (32.8 percent) or part time (21.3 percent). Diagnosis occurred at a median age of 37 years and half (45.2 percent) had been recently diagnosed within the last 5 years. Mild disability was reported in 54.8 percent of the patients.
About a fifth of the patients (19.3 percent, 429 patients) screened positive for depression and 21.8 percent were taking prescription medication for depression. However, 10 percent of those taking medication for depression stated they did not have depression. Of patients who screened positive for depression, 92.9 percent also screened for clinically significant fatigue. The patients reported the following symptoms:
- Little interest of pleasure in doing things: 18.9 percent
- Feeling down, depressed, or hopeless more than half the days or every day: 14.5 percent
- Depression as a comorbidity: 30.9 percent
- Of those who cited depression as a comorbidity, 70.6 percent reported receiving treatment for the condition
- Depression limits their activities: 39.1 percent
The following lifestyle factors were associated with low risks of screening positive for depression:
- Never smoking, but risk increased with former smokers and again in current smokers.
- Moderate alcohol intake, but risk increased in patients with low alcohol intake
- Exercise saw a dose response effect and was linked to lower risk of screening for depression
- Taking vitamin D was associated with low odds
- Using both omega 3 or fish oil supplements showed low odds, but flaxseed oil demonstrated the lowest odds
- Mediation, but not isolation, was associated with lower odds
- Obese patients screened positive more often than patients with normal BMI
- Increasingly poor diet and taking interferons also increased odds for positive screenings of depression
“This study demonstrates a strong clinically and statistically significant association between modifiable lifestyle factors and risk of depression,” the authors concluded. “Diet, smoking, exercise, omega 3 supplementation - particularly flaxseed oil - fish consumption, social support, vitamin D supplementation, BMI, alcohol intake, meditation and choice of medication are important modifiable factors in depression risk for people with MS. It is important for clinicians and people with MS to be aware of the wide range of modifiable lifestyle factors that may reduce depression risk as part of a comprehensive secondary and tertiary preventive medical approach to managing MS.”
Source: HCPLive © HCPLive 2015 (08/01/15)
Although some reports have suggested a link between human papillomavirus (HPV) vaccination and development of multiple sclerosis or other demyelinating diseases (a group of central nervous system disorders), a follow-up of girls and women in Denmark and Sweden who received this vaccination found no increased risk for these disorders, according to a study in the January 6 issue of JAMA.
Since the licensure of the quadrivalent human papillomavirus (qHPV) vaccine in 2006 and the later licensure of the bivalent HPV (bHPV) vaccine, more than 175 million doses have been distributed worldwide. The introduction of large-scale vaccination in a new target group—girls and young women—has been accompanied by a number of safety concerns, with the potential to undermine public confidence in the new vaccines. One concern is the development of multiple sclerosis, which has been fuelled by social and news media reports of cases occurring after HPV vaccination, and an increasing number of case reports published in the medical literature describing vaccine recipients who developed multiple sclerosis as well as other demyelinating diseases. It is not known if the occurrence of these conditions after HPV vaccination merely reflects the background rates in girls and young women or represents a true increased risk, according to background information in the article.
Nikolai Madrid Scheller, M.B., of the Statens Serum Institut, Copenhagen, Denmark, and colleagues conducted a study that included Danish and Swedish girls and women ages 10 years to 44 years, followed up from 2006 to 2013. The researchers used nationwide registers to identify the study group, information on qHPV vaccination, and data on incident diagnoses of multiple sclerosis and other demyelinating diseases.
A total of 3,983,824 girls and women were eligible for inclusion in the study group. Of these, a total of 789,082 were vaccinated during the study period, with a total of 1,927,581 qHPV vaccine doses. During follow-up, 4,322 multiple sclerosis cases and 3,300 cases of other demyelinating diseases were identified, of which 73 and 90, respectively, occurred within the risk period (two years following vaccination). After analysis of the data, the researchers found no increased risk of multiple sclerosis or other demyelinating diseases associated with qHPV vaccination.
“Our study adds to the body of data that support a favourable overall safety profile of the qHPV vaccine and expands on this knowledge by providing comprehensive analyses of multiple sclerosis and other demyelinating diseases. The size of the study and the use of nationwide registry data of unselected populations from Denmark and Sweden allowed adequately powered analyses that are likely generalisable,” the authors write.
“These findings do not support concerns about a causal relationship between qHPV vaccination and demyelinating diseases.”
Editor’s Note: The Swedish Foundation for Strategic Research, Novo Nordisk Foundation, and The Danish Medical Research Council funded the study. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.
Source: BioSpace Copyright © 2015 BioSpace.com (08/01/15)
Report of MS stem cell trial brings hope(05/01/15)
Three years after a small number of patients with multiple sclerosis (MS) were treated with high-dose immunosuppressive therapy (HDIT) and then transplanted with their own hematopoietic stem cells, most of the patients sustained remission of active relapsing-remitting MS (RRMS) and had improvements in neurological function, according to a study published online by JAMA Neurology.
MS is a degenerative disease and most patients with RRMS who received disease-modifying therapies experience breakthrough disease. Autologous (using a patient's own cells) hematopoietic cell transplant (HCT) has been studied in MS with the goal of removing disease-causing immune cells and resetting the immune system, according to the study background.
The Hematopoietic Cell Transplantation for Relapsing-Remitting Multiple Sclerosis (HALT-MS) study examines the effectiveness of early intervention with HDIT/HCT for patients with RRMS and breakthrough disease. The article by Richard A. Nash, M.D., of the Colorado Blood Cancer Institute at Presbyterian/St. Luke's Medical Center, Denver, and coauthors reports on the safety, efficacy and sustainability of MS disease stabilisation though three years after the procedures. Patients were evaluated through five years.
Study results indicate that of the 24 patients who received HDIT/HCT, the overall rate of event-free survival was 78.4 percent at three years, which was defined as survival without death or disease from a loss of neurologic function, clinical relapse or new lesions observed on imaging. Progression-free survival and clinical relapse-free survival were 90.9 percent and 86.3 percent, respectively, at three years. The authors note that adverse events were consistent with the expected toxic effect of HDIT/HCT and that no acute treatment-related neurologic adverse events were seen. Improvements in neurologic disability, quality-of-life and functional scores also were noted.
"In the present study, HDIT/HCT induced remission of MS disease activity up to three years in most participants. It may therefore represent a potential therapeutic option for patients with MS in whom conventional immunotherapy fails, as well as for other severe immune-mediated diseases of the central nervous system. Most early toxic effects were hematologic and gastrointestinal and were expected and reversible. Longer follow-up is needed to determine the durability of the response," the authors conclude.
In a related editorial, M. Mateo Paz Soldán, M.D., Ph.D., of the University of Utah, Salt Lake City, and Brian G. Weinshenker, M.D., of the Mayo Clinic, Rochester, Minn., write: "This study and another phase 2 single-arm study leave little doubt that high-dose immunotherapy is able to substantially suppress inflammatory disease activity in patients with MS who have active disease in the short term. There is some evidence for long-term suppression of MS. Lessons have been learned about how treatment-related morbidity and mortality may be reduced. However, deaths have occurred, even in small studies, and aggressive regimens have resulted in lymphomas associated with Epstein-Barr virus."
"Nash et al show evidence of prolonged depletion of memory CD4+ cells, depletion of CD4+-dominant T-cell receptor clones and evidence of 'immune reset'; however, clinical or radiologic evidence of relapse trumps immunologic evidence of immune reset, and this study raises concern that those end points have not been adequately achieved. The jury is still out regarding the appropriateness and indication of HCT for MS," the authors conclude.
Source: Medical Xpress © Medical Xpress 2011-2015, Science X network (05/01/15)
Studies in Sweden and Germany indicate that underweight women with multiple sclerosis who take the MS drug Gilenya (fingolimod) seem to be at increased risk for lymphopenia. The drug also poses a risk for patients who have low lymphocyte levels before they start drug treatment.
Lymphopenia (also known as lymphocytopenia) is a condition in which a person has a deficiency (penia) of lymphocytes, which are a subset of white blood cells (leukocytes). Lymphocytes, which can be T cells, B cells, or natural killer cells, play a crucial role in supporting immune system function.
It’s been known that fingolimod can lower the level of circulating lymphocytes. In fact, among the serious side effects reported by the Food and Drug Administration (FDA) and the drug’s manufacturer, Novartis Pharma Stein AG, is infections.
Risk of infections is increased because the drug lowers lymphocyte levels. The two newly reported studies cast new light on some of the factors associated with this risk.
In the German study, 418 individuals with relapsing-remitting multiple sclerosis were enrolled in an open label study in which they took 0.5 mg of fingolimod daily. Blood samples were collected on four separate occasions: immediately before treatment and at months 1, 4, and 6. In the Swedish study, data from 438 patients were used to validate the findings.
Here are some of the findings:
- Women who had a body mass index (BMI) less than 18.5 kg/m2 had a 26 percent increased risk for developing lymphopenia (counts at or lower than 0.2 x 109/L associated with drug use. This effect was not seen in men with this BMI.
- Individuals whose starting lymphocyte levels were less than 1.6 x 109/L had a 46 percent increased risk of lymphopenia while using the drug.
- Use of glatiramer acetate (Copaxone) before use of Gilenya seemed to help protect against the development of lymphopenia, although the researchers were uncertain about the immunologic effect of this drug.
Prior research (phase III trials) has indicated that the decline in lymphocyte counts among MS patients who take fingolimod is not associated with meal timing or the use of other medications, such as corticosteroids.
The findings of the two new studies provide doctors with additional information to consider when Gilenya is on the treatment table, such as monitoring of female patients who are underweight and/or individuals who have low baseline lymphocyte counts. Other serious side effects that may develop with use of Gilenya include slow heart rate (bradycardia), which can occur when starting treatment; macular edema, which typically appears after three to four months of treatment; liver problems; and shortness of breath.
Food and Drug Administration
Warnke C et al. Initial lymphocyte count and low BMI may affect fingolimod-induced lymphopenia. Neurology 2014. DOI:10.1212/WNL.0000000000001049
Source: Emaxhealth (05/01/15)
The link between the Hepatitis B vaccine and an increase risk of multiple sclerosis has been something of concern for a number of years since a increase in vaccinations in France led to a dramatic rise in cases of multiple sclerosis, also called MS. Now a new study being reported by Overcoming Multiple Sclerosis shows the link between the vaccine and the rise in MS cases — and explains what the mechanism may be behind this link, as well as other possible vaccine injuries and further supports older studies that found the same link from back in 2004 by a Harvard team.
Back in the 1990s, the WHO (World Health Organization) began pushing European countries to up their vaccine programs, and the Hepatitis B vaccine in particular, which they did in France. Prior to this, France had a steady rate of around 2,500 new cases of multiple sclerosis being diagnosed each year. After stepping up the vaccination program, roughly 20 million adults in France received the Hepatitis B vaccines. Following this vaccination program, the rate of cases of MS saw a sharp and dramatic rise to 4,500 per year.
One possible explanation for the Hepatitis B and multiple sclerosis link could be due to the autoimmune response triggered by the synthetic proteins used in the vaccines. The protein myelin is a type of fatty layer that offers protection as well as insulation for various cells in the brain and nervous system. The protein that is used in the vaccines may be similar to this one, which is found in the human body. What happens is that body’s own natural immune system responds to the foreign substance being injected and attacks it in hopes of triggering an immunity response. Since it is so similar to the myelin, the body then mistakenly begins to read those proteins as a foreign danger and attacks them as well. This can then damage the myelin and the theory is that that damage could lead to, or accelerate, multiple sclerosis, which is a demyelinating disorder.
Some believe that this same mechanism could also be what is behind the vaccine-autism link. As David Kirby explains at Age of Autism, “Myelin damage has long been suspected in autism, though the jury is still out on this question. One thing that does seem to be certain is that children with ASD [Autism Spectrum Disorder] appear to have unusually high levels of antibodies to myelin basic protein, or MBP. That would suggest they might have myelin damage as well. Some studies have also shown highly elevated levels (up to 90 [percent]) of MBP antibodies in ASD children who received the MMR vaccine. The development of MBP antibodies could possibly be caused by a reaction to the live measles virus in the vaccine, because the virus may mimic the molecular structure of MBP.”
Similar findings to this study were also published in a 2004 issue of the journal Neurology by a Harvard research team and Age of Autism is also reporting that the National Vaccine Court, which handles cases of vaccine injuries, has ruled in favor of patient claims that the Hepatitis B vaccine was responsible for the patients developing MS.
While experts say that more research is needed this offers more pieces to the complicated puzzles and links between vaccines and various health conditions, including the Hepatitis B vaccine link to multiple sclerosis and other vaccines possibly linked to autism in children.
Source: Inquisitr © 2008 - 2015 The Inquisitr News. (05/01/15)
Just days before her death right-to-die campaigner Debbie Purdy said legal guidelines on assisted dying did not go far enough to prevent people "dying badly".
Ms Purdy, 51, who won a House of Lords ruling which resulted in new government guidelines on assisted suicide in 2009, died on 23rd December after deciding to end her life having battled primary progressive multiple sclerosis for nearly 20 years.
In an article published in the Independent on Sunday, written shortly before she died through refusing food, Ms Purdy said Lord Falconer's Assisted Dying Bill was "not good enough as it is" although she hoped it would pass into law.
And she admitted her husband Omar Puente had wanted her to change her mind "up until the very last minute".
She wrote: "I just hope others succeed where I have ultimately failed, and that Britain will see an appropriate assisted dying law soon, so that no one else has to work as hard as I have to have some choice and control over the way I die."
Source: ITV © Copyright ITV plc 2015 (05/01/15)