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Confirmation of association between Multiple Sclerosis, CYP27B1 & Vitamin D

Sunday, July 25th, 2010 | Tags: , , , , , , , , , , , , , , , , , , , , ,
Posted in External News Articles, Uncategorized

Confirmation of association between multiple sclerosis, CYP27B1 and vitamin D

Multiple sclerosis, MS (OMIM No. 126200), is a complex inflammatory disease that is characterized by lesions in the central nervous system.

Both genes and other environmental factors influence disease susceptibility. One of the environmental factors that has been implicated in MS and autoimmune disease, such as type 1 diabetes, is vitamin D deficiency, in which patients have lower levels of 25-hydroxyvitamin D3 (25-OHD3) in blood than do controls.

Previtamin D3 is produced in the skin, and turned into 25-OHD3 in the liver. In the kidney, skin and immune cells, 25-OHD3 is turned into bioactive 1,25(OH)2D3 by the enzyme coded by CYP27B1 (cytochrome P450 family 27 subfamily B peptide 1) on chromosome 12q13.1–3. 1,25(OH)2D3 binds to the vitamin D receptor, expressed in T cells and antigen-presenting cells. 1,25(OH)2D3 has a suppressive role in the adaptive immune system, decreasing T-cell and dendritic cell maturation, proliferation and differentiation, shifting the balance between T-helper 1 (Th1) and Th2 cells in favor of Th2 cells and increasing the suppressive function of regulatory T cells. Rs703842 in the 12q13–14 region was associated with MS in a recent study by the Australian and New Zealand Multiple Sclerosis Genetics Consortium (ANZgene).

We show associations with three SNPs in this region in our Swedish materials (2158 cases, 1759 controls) rs4646536, rs10877012 and rs10877015 (P=0.01, 0.01 and 3.5 × 10−3, respectively). We imputed rs703842 SNP and performed a joint analysis with the ANZgene results, reaching a significant association for rs703842 (P=5.1 × 10−11; odds ratio 0.83; 95% confidence interval 0.79–0.88).

Owing to its close association with 25-OHD3, our results lend further support to the role of vitamin D in MS pathology.

  1. 1Neuroimmunology Unit, Department of Clinical Neuroscience, Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden
  2. 2Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
  3. 3Department of Clinical Neuroscience, Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden

Correspondence: E Sundqvist, Neuroimmunology Unit, Department of Clinical Neuroscience, Center for Molecular Medicine L8:04, Karolinska Institutet, Stockholm 17176, Sweden. Tel: +46 85 177 6258; Fax: +46 85 177 6248; E-mail: Emilie.Sundqvist@ki.se

Received 4 December 2009; Revised 19 March 2010; Accepted 4 June 2010; Published online 21 July 2010.

http://www.nature.com/ejhg/journal/vaop/ncurrent/abs/ejhg2010113a.html

First patient enrolled in Phase II BG-12 combination trial in Multiple Sclerosis

Tuesday, June 15th, 2010 | Tags: , , , ,
Posted in Uncategorized

Biogen Idec today announced enrollment of the first patient in a multicenter Phase II clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS).

The trial, called EXPLORE, will evaluate the safety and tolerability of BG-12 when administered with beta interferons (IFNB) or glatiramer acetate (GA) to patients who continue to have evidence of disease activity despite receiving consistent monotherapy for at least a year. Efficacy endpoints will also be assessed in a subset of patients.

“An ongoing treatment challenge in MS is that many patients continue to experience disease activity despite being on therapy,” said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. “The goal of the EXPLORE trial is to evaluate whether BG-12 may be a safe and effective agent to use in combination with other MS therapies, an important consideration for patients for whom new treatment strategies are needed.”

BG-12 is the first compound in trials for the treatment of MS that has been shown to activate the Nrf2 transcriptional pathway.

Experimentally, the Nrf2 pathway has demonstrated neuroprotective and anti-inflammatory properties. Activation of this pathway in MS patients may potentially prevent further cell damage and tissue loss caused by the disease.

Preclinical studies have shown that activation of the Nrf2 pathway defends against oxidative-stress induced neuronal death, protects the blood-brain barrier and supports maintenance of myelin integrity in the central nervous system. Central nervous system inflammation and damage may trigger the symptoms common in RRMS such as fatigue, cognitive deterioration and physical disability.

Data from the Phase IIb study in RRMS, combined with experimental data showing BG-12’s ability to activate the Nrf2 pathway, continue to support its evaluation as a monotherapy in two extensive ongoing Phase III MS studies, DEFINE and CONFIRM, which are fully enrolled. These data also support its further investigation as a combination therapy in EXPLORE.

“The MS community is eager for new treatment options for this debilitating disease,” said Robert Fox, M.D., Staff Neurologist and Medical Director at the Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and Research. “BG-12 may offer patients an additional treatment strategy. Its potential to both reduce inflammation and promote neuroprotection, its safety data to date, as well as its oral administration, support this study of BG-12 as a possible combination therapy for MS.”

“The EXPLORE trial is another demonstration of Biogen Idec’s commitment to MS,” said Dr. Sandrock.“We have one of the most extensive MS pipelines in the industry, with multiple programs that target pathways thought to be critical in treating MS. This pipeline includes late-stage programs such as BG-12, PEGylated interferon beta 1a, and daclizumab, earlier-stage programs such as anti-LINGO, and several preclinical programs.”

About EXPLORE

EXPLORE is an open-label, multicenter Phase II clinical trial that will enroll approximately 100 RRMS patients in the United States currently receiving IFNB or GA as monotherapy.

Patients in the trial must have received consistent therapy with IFNB or GA for at least one year prior to enrolling in the trial and have evidence of disease activity. EXPLORE will primarily evaluate the tolerability and safety of BG-12 as a combination therapy by the incidence and type of adverse events (AEs), serious AEs and AEs leading to discontinuation of study treatment, as well as the incidence and type of laboratory abnormalities and MS disease activity in all study patients.

In a subset of patients, the study will also investigate the efficacy of BG-12 in combination with IFNB or GA by evaluating the mean number of new and total gadolinium-enhancing (Gd+) lesions on brain MRI scans.

Patients enrolled in EXPLORE will have monthly MRIs. They will continue on their prescribed treatments (IFNB or GA) for two months, at which point they will receive 240 mg of BG-12 three times daily in combination with their existing treatment for an additional six months.

About BG-12

BG-12 (BG00012, dimethyl fumarate) is an investigational oral therapy in Phase III clinical development as a monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS), the most common form of MS, and in Phase II clinical development for rheumatoid arthritis (RA). BG-12 received Fast Track designation in MS from the U.S. Food and Drug Administration (FDA), which may expedite U.S. regulatory review. Biogen Idec retains full worldwide commercial rights to BG-12.

The Phase IIb study of BG-12, which was published in The Lancet, showed that BG-12 as a monotherapy reduced the number of new gadolinium enhancing (Gd+) lesions by 69 percent in patients with RRMS when compared to treatment with placebo (p<0.0001). The presence of Gd+ lesions is thought to indicate continuing inflammatory activity within the central nervous system. Results from this study stimulated further evaluation of BG-12’s potential for neuroprotection.

Source: Biogen Idec (15/06/10)

FDA approves Botox to treat wrist, finger spasms

Wednesday, March 10th, 2010 | Tags: , , , , , , , ,
Posted in Uncategorized

U.S. regulators on Tuesday approved the use of Allergan Inc’s wrinkle smoother Botox to treat spasms of the elbow, wrist and fingers in adults.

The U.S. Food and Drug Administration said it approved the drug to treat spasticity in the flexor muscles, a condition that can result from stroke, brain injury or multiple sclerosis. The muscles can become stiff and painful, affecting patients’ daily activities.

Botox works by blocking the connections between nerves and muscles, temporarily paralyzing the spastic muscle.

Botox carries a strong warning indicating the effects of botulinum toxin may spread from the injection site to other parts of the body, causing symptoms including swallowing and breathing difficulties that can be life-threatening.

In addition to cosmetic uses, Botox is approved to treat underarm sweating and a condition known as cervical dystonia that causes neck spasms. It is being tested for a variety of medical uses, including migraine headaches.

CHICAGO (Reuters)

Schoolboy proud of vitamin D campaign

Tuesday, February 9th, 2010 | Tags: , , , , , , , , , , , , , , , , ,
Posted in Uncategorized

ryanandkirsten

heraldscotland staff

Published on 9 Feb 2010

A schoolboy who petitioned the Scottish Parliament about possible links between vitamin D and multiple sclerosis has said he is proud of what he had achieved.

Ryan McLaughlin, 14, took his case to Holyrood’s Public Petition Committee last summer.

The petition called on ministers to produce new guidelines on vitamin D supplements for children and pregnant women, along with an awareness campaign about the issue.

The Scottish Government has now agreed to support and host a summit in April on the role of vitamin D and to produce the guidance on supplements.

Ryan took up the cause after watching his mother Kirsten suffering the incurable disease.

The Public Petitions Committee has greed to close his petition.

Ryan said afterwards: “After an amazing year in raising both vitamin D and MS awareness, I now have the commitments that I wanted from the Scottish Government.

“I applaud the positive action taken by the Scottish Government and the support from Deputy First Minister Nicola Sturgeon and Shona Robison, Health and Sports Minister.”

Ryan’s local MSP Bill Butler hailed the campaigning schoolboy’s achievement, saying “a very great deal of progress” has been made.

The Glasgow Anniesland MSP praised how “Ryan and the McLaughlin family have persuaded the Government and the Government has listened to the very sensible suggestions contained in the petition”.

He said: “The Government has agreed to a co-ordinated programme of action with NHS Scotland to produce guidance on vitamin D, to educate women on its importance, to consider different messages for different groups of people and to ensure that health professionals are giving correct and consistent advice to pregnant women and new mothers in relation to vitamin D.”

He described that as a “significant success”, and added: “It’s people listening to what is a very sensible set of suggestions from someone whose personal circumstances have convinced him that there is need for reform here.

“It’s a success story.”

A spokeswoman for the Scottish Government said: “We’re keen to learn all we can about any possible links between vitamin D and multiple sclerosis and are keeping a very close eye on all the emerging evidence.”

http://www.heraldscotland.com/news/politics/schoolboy-proud-of-vitamin-d-campaign-1.1005227

Glaxo looks to grab big profits from new MS drugs

Sunday, February 7th, 2010 | Tags: , , , , , , , , , , , , , , , , ,
Posted in Uncategorized

GlaxoSmithKline Plc will halt research into drugs for depression and pain and begin making treatments for rare diseases as the U.K. company tries to squeeze more products out of its laboratories.

Glaxo will also focus on discovering new medicines for Alzheimer’s and Parkinson’s diseases and multiple sclerosis, the London-based company said today in a statement. Chief Executive Officer Andrew Witty said an expanded cost-savings program would bring job cuts affecting “hundreds rather than thousands” of positions in the U.K.

Britain’s biggest drugmaker is seeking new products to keep sales rising after revenue from swine flu vaccine falls and older medicines lose patent protection. Fourth-quarter sales surged 17 percent, helped by sales of H1N1 flu vaccine, Glaxo said today. Glaxo is trying to weed out compounds from its 3.95 billion pound ($6.25 billion) research budget that are expensive to develop and provide little return on investment, Witty said.

“This really all revolves around realities about doing research in this field,” Witty said of depression and pain projects on a conference call with reporters. Developing a drug that’s significantly better than existing medications is difficult and “they’re very expensive trials. That’s what drove the decision.”

Orphan Status

“If you want to save money in R&D, that’s a sensible area to go,” Jeffrey Holford, an analyst at Jefferies International Ltd., said in an interview. “Depression hasn’t delivered very many great medicines in the recent past for anyone full stop.” Orphan drugs “are a very profitable area.”

Paxil, a Glaxo antidepressant that’s already on the market, has proved costly. The drugmaker has paid almost $1 billion to resolve lawsuits for over the drug since it was introduced in 1993, including about $390 million for suicides or attempted suicides, according to court records and people familiar with the cases. The drug brought in 513 million pounds of sales last year.

Witty said fewer than 10 percent of rare diseases have treatments. Glaxo in October agreed to pay as much as 460 million euros ($637 million) to develop drugs from closely held Dutch biotechnology company Prosensa aiming to treat Duchenne muscular dystrophy.

Savings Plan

Profit excluding some items gained to 35.4 pence a share in the quarter, beating the 33.5 pence average estimate of 16 analysts surveyed by Bloomberg. Net income was 1.63 billion pounds, compared with 982 million pounds a year ago, Glaxo said in the statement. Sales rose to 8.09 billion pounds.

Glaxo plans to add 500 million pounds of savings by 2012. The previous plan was to save 1.7 billion pounds a year by 2011.

New products generated 1.3 billion pounds of sales in 2009, 15 percent more than the previous year. Generic copies of Glaxo medicines hurt U.S. sales by 1.4 billion pounds.

“The problem for this company in terms of R&D has been that the revenue line is so big that they need to have an equally big portfolio of drugs coming through the pipeline to fill the holes,” Holford said. “Now that their patent drag is starting to ease off and it’s a more steady state then the pipeline can start to become more meaningful.”

Shares Rise

Glaxo shares gained 9 pence, or 0.7 percent, to close at 1,226 pence in London. The stock has fallen 3.3 percent in the past year, compared with a 13 percent rise in the Bloomberg Europe Pharmaceutical Index.

Germany and France were among the European countries to slash orders for the drugmaker’s swine flu vaccine after the virus was milder than predicted. The shot brought in 835 million pounds for Glaxo in the fourth quarter, below the 1 billion pounds in sales expected by Credit Suisse analyst Luisa Hector before the cancellations.

Sales of the vaccine helped offset revenue lost to generic copies of antiviral drug Valtrex, which hit the market in November. Valtrex revenue dropped 8 percent to 1.3 billion pounds in 2009.

“We remain concerned about the 2010 order book” for the swine flu vaccine, Hector and colleagues wrote in a Jan. 27 note to clients. Earnings in 2010 will be “flat at best,” hurt by the loss of the flu windfall and by a faster-than-expected sales decline for Valtrex after the patent expiry, they wrote.

Emerging Economies

Since taking over the top job two years ago, Witty has stepped up expansion in consumer goods and emerging economies, making dozens of small acquisitions and licensing ventures in 2009.

He repeated his strategy to stick with smaller, “bolt-on” acquisitions “only if we can find deals with clear financial hurdles,” he said. “We’ll have to see.”

Glaxo’s earnings per share exclude restructuring charges related to what it calls “significant” acquisitions and costs from the savings program, which started in October 2007

Italian group offers $4.5M to fund new MS research on CCSVI

Friday, January 29th, 2010 | Tags: , , ,
Posted in Uncategorized

The Italian Multiple Sclerosis Foundation today announced it will allocate up to $4.5 million to fund ongoing research into CCSVI, a condition linked to Multiple Sclerosis.

The foundation says it is accepting research proposals until March 8 from scientists interested in studying “chronic cerebro-spinal venous insufficiency,” a newly-discovered condition uncovered by a team at the University of Ferrara in Italy and lead scientist Dr. Paolo Zamboni.

“We await proposals from groups of Italian researchers, in particular by the research groups that are already active with Prof. Zamboni,” the foundation said in an Italian news release.

Zamboni’s team believes that CCSVI causes veins in the neck and upper chest to twist, narrow or become blocked; in some cases, these veins never form at all. The result is poor blood drainage from the brain. Zamboni has found that more than 90 per cent of patients with MS have these malformed veins, and improper blood flow from the brain.

Roberta Amaedo, president of the Italian Association for Multiple Sclerosis, said in the release: “We need certainty about the relationship between MS and CCSVI and on the clinical course that this can cause, and on that, clinical trials will make an important contribution.”

The association also cautioned patients against seeking endovascular or surgical procedures to open these blocked veins outside of controlled research studies.

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