MS Society partners in CCSVI clinical trial
September 28, 2012 – Halifax –
The Multiple Sclerosis Society of Canada welcomes the federal government’s announcement that the Phase I/II clinical trial for chronic cerebrospinal venous insufficiency (CCSVI) has received the necessary medical and ethical approvals required to proceed. The national MS clinical trial is a collaborative initiative between the Government of Canada, provinces and territories, and the MS Society. In September 2010, the MS Society committed funding towards the financial cost of a clinical trial to support a pan-Canadian interventional clinical trial on CCSVI and MS. The clinical trial will be led by Dr. Anthony Traboulsee of the UBC Hospital MS Clinic and his collaborators. Dr. Traboulsee and his team received ethics approvals from institutions in British Columbia and Quebec to study the safety of venous angioplasty and gather information on patient outcomes. Ethics approval is still ongoing in Manitoba. “We are excited that the clinical trial is underway and that MS is being recognized as a top-priority health issue that is meaningful to Canadians,” says Yves Savoie, president and CEO of the MS Society of Canada. “The research of Dr. Traboulsee and his team will provide significant insights to those living with MS and provide answers to the many questions that exist around CCSVI and MS.” According to the announcement, participant recruitment for the trials will start by November 1, 2012. “When it comes to my health, I have a lot of questions and I want all the information possible – I am hopeful that this clinical trial will help me answer some of the questions my family and I have about CCSVI,” says Theresa Denham who has been diagnosed with MS for 22 years. -30- For more information about the seven CCSVI studies funded by the MS Society and the National Multiple Sclerosis Society please visit ccsvi.ca. About multiple sclerosis and the Multiple Sclerosis Society of Canada Multiple sclerosis is a chronic, often disabling disease of the brain and spinal cord. It is the most common neurological disease of young adults in Canada. Most people with MS are diagnosed between the ages of 15 and 40, and the unpredictable effects of MS last for the rest of their lives. The MS Society provides services to people with MS and their families and funds research to find the cause and cure for this disease. Please visit mssociety.ca or call 1-800-268-7582 to make a donation or for more information.
A chemical that can be used as a food additive, caused serious skin infections after people sat on sofas treated with it and was approved as a psoriasis treatment in Germany 15 years ago, may prove to be a viable treatment option for people with the relapsing-remitting form of multiple sclerosis (MS).
Dimethyl fumarate - also known so far as BG-12 - could be another weapon in a neurologist's arsenal to treat the disease, if the drug is approved. Based on the results of two large studies published in the New England Journal of Medicine, experts believe this is likely.
More than 2 million people around the world live with MS, a disease where the body's immune system attacks the patient's central nervous system and destroys the myelin, or sheath, protecting nerve cells. Most people are diagnosed between the ages of 20 and 50, and more women than men are affected, according to the National MS Society. As the disease progresses, it can become quite debilitating, leading to numbness and difficulty walking and seeing among many other symptoms.
"Relapsing MS is a disease that we have treatments for, but they're really on two ends of the spectrum," says Dr. Robert Fox, a neurologist at the Mellen Center for MS at the Cleveland Clinic. "We have injection treatments that have modest efficacy. They reduce relapses by about 30%.
"And we have very effective therapies, but they are infusion therapies and they have risk - risks of a brain infection - that may be fatal," Fox says. "This new treatment offers the opportunity for sort of the best of both worlds, in that it has very good efficacy, but it's in the form of a pill and appears to have much reduced risk than other therapies."
Fox, who is the lead author of one of the studies, says both studies published Wednesday were designed in the same way so their results could be examined together. Both were large trials involving more than 1,400 patients in many countries and both compared BG-12 to a placebo - a common scenario when seeking drug approval.
He says both studies showed BG-12 reduced the number of relapses, reduced the number of lesions or scars on the brain and progression of disability and was more effective than standard injectable MS drugs.
Both studies found BG-12 was well tolerated and seems to be safe. They looked at taking the pill two and three times day. Fox says between the two studies, taking the pill three times a day wasn't significantly better than twice a day, which is why the FDA drug approval application only refers to twice daily dosing.
Timothy Coetzee, chief medical research officer for the National MS Society, says the study results look very promising. He says it's a "good news story for people who live with MS" because the pill has been shown to be effective in reducing the number of relapses. Coetzee says it's too early to say BG-12 is superior to other MS drugs in pill forms, as studies haven't been done yet.
Based on these results of these two studies, Fox and Coetzee believe the FDA will approve the drug. Only after that happens will we know what name manufacturer Biogen Idec will sell BG-12 or dimethyl fumarate under, as well as its price. The FDA has until December 28 to make a decision.
If this happens, BG-12 would be the third MS drug in pill form approved by the FDA. Just last week, the agency approved another MS drug in pill called Aubagio. It too was shown to be effective in reducing the number of relapses, slowing down disease progression and reducing the number of brain lesions. The first pill, Gilenya, was approved two years ago.
Like any drug, these new MS drugs in pill form have their pros and cons. Each of these pills "targets a different part of the immune system in a very specific manner," says Coetzee, which may influence what a patient may be prescribed and how they react to each drug.
Side effects also are a consideration. Since people as young as 20 could be diagnosed with this disease that affects 2.1 million people worldwide, women who want to get pregnant or who are pregnant would not be a candidate for Aubagio because it could cause severe birth defects.
Patients taking Gilenya have to be monitored for the possibility of their heart rate slowing down. Earlier this year, health agencies in the United States and Europe were reviewing safety concerns after 11 deaths were linked to patients taking Gilenya.
BG-12 is not without side effects. The two-year clinical trials showed common side effects including skin flushing and some nausea, vomiting and diarrhea - usually in the first month. After that, Fox says, patients did quite well. What hasn't been seen in patients so far is an increased risk of infections or cancer with this drug, says Fox.
And then there are still the older injectable and infusion drugs that may still work very well for those patients taking them. Coetzee believes some patients may want to wait until these drugs stop being effective and then shift to another option.
Cost could be another
issue. Aubagio costs about $45,000 per year; Gilenya about $48,000.
Twenty-five years ago, options were few for MS patients. Now doctors and patients have nine options and perhaps 10 by the end of the year. "That's really good news, if you're diagnosed with the relapsing forms of MS," says Coetzee. But he notes that those with more progressive forms of the disease are still awaiting treatment choices.
Two proof-of-concept clinical trials have provided evidence that laquinimod reduces disease activity in patients with relapsing–remitting multiple sclerosis.
We conducted a randomized, double-blind, phase 3 study at 139 sites in 24 countries. A total of 1106 patients with relapsing–remitting multiple sclerosis were randomly assigned in a 1:1 ratio to receive oral laquinimod at a dose of 0.6 mg once daily or placebo for 24 months. The primary end point was the annualized relapse rate during the 24-month period. Secondary end points included confirmed disability progression (defined as an increase in the score on the Expanded Disability Status Scale that was sustained for at least 3 months) and the cumulative number of gadolinium-enhancing lesions and new or enlarging lesions on T2-weighted magnetic resonance imaging.
Treatment with laquinimod as compared with placebo was associated with a modest reduction in the mean (±SE) annualized relapse rate (0.30±0.02 vs. 0.39±0.03, P=0.002) and with a reduction in the risk of confirmed disability progression (11.1% vs. 15.7%; hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.91; P=0.01). The mean cumulative numbers of gadolinium-enhancing lesions and new or enlarging lesions on T2-weighted images were lower for patients receiving laquinimod than for those receiving placebo (1.33±0.14 vs. 2.12±0.22 and 5.03±0.08 vs. 7.14±0.07, respectively; P<0.001 for both comparisons). Transient elevations in alanine aminotransferase levels to greater than three times the upper limit of the normal range were observed in 24 patients receiving laquinimod (5%) and 8 receiving placebo (2%).
In this phase 3 study, oral laquinimod administered once daily slowed the progression of disability and reduced the rate of relapse in patients with relapsing–remitting multiple sclerosis.
One is the loneliest number, at least according to a song written by Harry Nilsson in 1967 (and made famous by Three Dog Night in 1969). Though social interactions are a basic emotional necessity, for a patient plagued with increasing physical disability along with fatigue and an assortment of other symptoms, sometimes one is just about all you can handle. Chronic disabling illness often brings with it a troublesome companion: isolation, a condition that is often feared, but which has a more benign companion, solitude. The problem of isolation/solitude is a paradoxical one; although in anticipation loneliness is often dreaded, there are times, when caught in the thicket of illness, when a patient just wants to be left alone.
MS Society of Canada - Living with MS - MS Updates
Gilenya (fingolimod) under Health Canada review
February 28, 2012
Health Canada has announced an ongoing safety review of Gilenya (fingolimod) following the reports of serious adverse events, including 11 deaths internationally. At this time, it is not clear whether the deaths were caused by Gilenya or whether other factors may have played a role. There have been no deaths in Canada. Details
Health Canada’s review was initiated following reports earlier this year that 11 deaths have occurred among people being treated with Gilenya, including the report of an American who died within 24 hours of receiving a first dose of Gilenya in December 2011.
At the time of approval in March 2011, it was known that Gilenya could be associated with certain types of heart rhythm disturbances. The Health Canada labeling for Gilenya includes several important warnings related to these risks however, provided Gilenya is used as recommended in the authorized Health Canada drug label, the benefits of Gilenya are considered to outweigh the risks at this time.
Health Canada is advising healthcare professionals to continue to follow the labeling instructions closely, particularly with respect to patient monitoring. Specifically, the label recommends that physicians:
Obtain an ECG (electrocardiogram) before the first dose if one is not available in the last 6 months
Observe patients for signs and symptoms of bradyarrhythmia (slow heart rate), including periodic assessment of heart rate, for at least six hours after the first dose (or if more than two weeks have passed since the previous dose).
Initiate appropriate treatment if clinically important heart-related symptoms occur. Symptoms include bradyarrhythmia or atrioventricular block (a problem with the conduction of electricity in the heart). Continue to manage and monitor patients until symptoms have resolved.
Measure blood pressure regularly as Gilenya is known to increase blood pressure.
REGINA -- Saskatchewan MS patients hoping to take part in a clinical trial of a controversial treatment may soon get a call from the ministry of health.
Only 10 per cent of those who applied will get that call.
Deb Jordan, a ministry spokeswoman, said 670 people had signed up as of Thursday. The deadline to apply for the two-year, double-blind trial of liberation therapy was midnight Friday.
Jordan said names will be randomly drawn starting next week to determine who will fill 86 spots in the test taking place in Albany, N.Y. A successful candidate must be a Saskatchewan resident, under the age of 60 and not had liberation treatment.
"Once we verify that information, then the applicant will be forwarded to the folks who are involved in the clinical trial," said Jordan. "I want to also emphasize that the fact that a patient may be drawn does not necessarily mean that they will move on to the clinical trial.
"There's the medical assessment that has to take place by the team and it is the... clinical team that is operating the clinical trial that will ultimately make the decisions about the patients who will be participating in the trial."
Jordan said the process could take several months.
The treatment is based on a hypothesis by Italian vascular surgeon Dr. Paolo Zamboni that a condition he dubbed chronic cerebrospinal venous insufficiency, or CCSVI, may be linked to multiple sclerosis. The theory suggests narrowed neck veins create a backup of blood that can lead to lesions in the brain and inflammation. Liberation therapy involves opening up blocked neck veins.
The idea has divided the medical community.
Some patients have reported improvement after the therapy. Other studies have raised doubts about its effectiveness and questioned the benefits when weighed against the risks.The procedure is not offered in Canada and some patients have travelled around the world to seek it out. At least two Canadians have died after having the treatment.
Saskatchewan has some of the highest rates of MS in the country. Canada's rate of MS is among the highest in the world at 240 per 100,000 people. On the Prairies, the rate is 340 per 100,000 people.
CBC -The Nature of Things with David Suzuki - Episode - MS Wars: Hope, Science and the Internet
MS Wars is a one hour documentary that delves into the science, controversy and human drama around Liberation Therapy. It is a tale that explores how the Internet has spurred a social network movement that is changing the doctor/patient relationship and the repercussions for physician and institutions.
In some patients, multiple sclerosis attacks the body in such a way that leg muscles begin to deteriorate, and many patients end up with a cane or walker before they reach old age.
But mobility problems often do not appear until the disease has progressed. Doctors have a hard time identifying mobility deficits, or muscle weakness until the symptoms became more obvious.
But according to a new study, a series of tests for muscle endurance and gait could identify....read more
Reports from seven multi-disciplinary teams investigating CCSVI (chronic cerebrospinal venous insufficiency) in MS indicate that they are making good progress toward providing essential data and critical analysis as these two-year projects move toward their completion. The studies were launched on July 1, 2010 with a more than $ 2.4 million commitment from the MS Society of Canada and the National MS Society (USA). The ongoing work by the seven teams will help inform the design of an early-phase clinical trial that is expected to launch in late spring 2012 with funding from the MS Society of Canada and the Canadian Institutes of Health Research (CIHR).
The research teams have recruited and scanned a broad spectrum of people with MS and others to build understanding of who may be affected by CCSVI. In addition they are refining CCSVI imaging methods for accuracy and consistency to reliably validate the occurrence of CCSVI and understand its implications in
REGINA -- Saskatchewan says it will send multiple sclerosis patients to the U.S. for the clinical trial of a controversial treatment -- an announcement that prompted more than 100 applications within hours.
Premier Brad Wall said a New York state doctor is in the final stages of getting U.S. federal approval for what's believed to be the largest "liberation" therapy trial of its type. The province is providing $2.2 million so 86 MS patients can be included in the two-year, double-blind trial at the Albany Medical Center, said Wall.
The procedure is not currently offered in Canada and some patients have traveled around the world to seek it out despite it having not been proven to work.
"While we're talking here, people are raising money and having bake sales and getting the support of neighbours and friends to try to go somewhere to have the treatment. Well, we should find some answers," said Wall.
The double-blind aspect of the study means only half of the patients will actually receive the treatment. The patient and the physicians who do the followup will not know if they got the treatment.
"They'll knowingly volunteer for the trials understanding that they may not get the treatment, which of course is probably what many would like to have. But they're going to do it in the interest of science, in the interest of demonstrating the efficacy of this treatment or coming to some other conclusion, which would also be helpful," said Wall.
More than 130 applications were submitted within five hours of Wall's announcement. People have until Feb. 24 to apply either through the government's website or a toll-free line.
The province says those selected will be contacted and the first patients can expect to travel to Albany in March.
"We know that there will be some applicants that will be disappointed, but I can assure you that all will be given an equal chance," said Health Minister Don McMorris.
The treatment is based on a hypothesis by Italian vascular surgeon Dr. Paolo Zamboni that a condition he dubbed chronic cerebrospinal venous insufficiency, or CCSVI, may be linked to multiple sclerosis. The theory suggests narrowed neck veins create a backup of blood that can lead to lesions in the brain and inflammation.
Liberation therapy involves opening up blocked neck veins. But the idea that the condition might be linked to the progressive neurological disease has divided the medical community.
With a population of slightly more than one million, Saskatchewan has some of the highest rates of MS in the country. An estimated 3,500 Saskatchewan residents have MS. Canada's rate of MS is among the highest in the world at 240 per 100,000 people. On the Prairies, the rate is 340 per 100,000 people.
Saskatchewan was the first province to pledge clinical trials when it put up $5 million and issued a call for proposals in October 2010. The goal was to proceed with clinical trials by spring 2011.
-- The Canadian Press
Trials seem delayed
Manitoba was slated to announce last month which researchers in this province will share $5 million earmarked for clinical trials of the "liberation" therapy.
But the government has apparently delayed the announcement. Also, it won't say how many research proposals it received, how many were chosen for peer review or how many made the short list.
Last spring, with significant fanfare, Manitoba earmarked $5 million and put out a call for proposals relating to the liberation-therapy treatment.
The province's deadline to receive proposals was Sept. 30, and scientific peer review was to be completed in November.
Despite at least two separate freedom-of-information requests, a spokesman for Manitoba Health said due to the Manitoba Health Research Council's protocol, the number of proposals, the names of applicants and individuals sitting on the review committee cannot be released to the public.
A new study from researchers at Queen Mary, University of London shows how a particular virus tricks the immune system into triggering inflammation and nerve cell damage in the brain, which is known to cause MS.
Previous research has suggested a link between the Epstein-Barr virus (EBV) and multiple sclerosis but the research has remained controversial since scientists have so far failed to substantiate the link.
The new study proves the virus is involved in a manner more sophisticated and subtle than previously imagined, and may offer new ways to treat or prevent the disease. read article here
Dr. Joanne Kurtzberg of Duke University tells Scott Pelley that stem cells purchased from one of the hundreds of websites promising stem cell cures for incurable diseases could actually cause a patient serious harm. The chief scientific officer for Duke's stem cell research program spoke to Pelley as part of an eight-month investigation into the illicit stem cell industry.
In the report, "60 Minutes" cameras capture a disgraced doctor trying to sell an unproven stem cell treatment to the parents of a child with cerebral palsy. Pelley's investigation will be broadcast on "60 Minutes" on Sunday, Jan. 8 at 8 p.m. ET/PT.
Kurtzberg decries the websites offering unproven stem cell remedies for what are currently incurable diseases like autism, multiple sclerosis, Alzheimer's and every kind of cancer. She hears from patients who see those websites and has to inform them that thus far, stem cells have been used to successfully treat leukemia and a few rare genetic diseases and nothing else. "It's very dishonest to mislead people when there is nothing you can do," says Kurtzberg. "I believe stem cells have a lot of promise, but we are way at the infancy," she tells Pelley.
"60 Minutes" worked with Gary and Judy Susser, parents of Adam, who has cerebral palsy, to investigate one of the online purveyors of stem cell treatments, Stem Tech Labs of Ecuador. Such labs are offshore because what they are doing is mostly illegal in the U.S. The lab, run by an American doctor named Dan Ecklund whose license to practice medicine was revoked in Alabama, promises a "modern day miracle" and "treating or curing over 70 diseases." "60 Minutes" cameras captured Ecklund on a teleconference from Ecuador promising the Sussers that Adam would have a "75 percent chance...he would have a noticeable improvement." He would come to Florida to administer four stem cell transplants for which he would charge $5,000 each. In a Miami-area hotel room set with hidden cameras, Pelley confronts Ecklund about his intentions to treat the child.
"60 Minutes" purchased some stem cells from Ecklund's website and had Kurtzberg examine them in her lab at Duke. Dr. Kurtzberg discovered that only 100 of the 20 million umbilical cord blood stem cells bought for $5,000 were still alive. The dead cells are cellular debris and dangerous says Kurtzberg. "There are huge dangers if you inject that into someone's blood or spinal fluid because all these little fragments and debris would get trapped somewhere in the bloodstream and could cause a stroke...do a great deal of harm," Kurtzberg tells Pelley.
Adam, 11, did not get the treatments; his parents had been down that route before in 2003 when they took him to Mexico for similar treatments that produced no miracles. The Sussers want others to beware. "People are preyed upon by hucksters and charlatans... It's about getting rich at someone's expense," says Gary Susser. "And people with a special child don't need anymore expense...heartache...false promises. They need the truth and they need hope."
Copaxone repairs nerve tissue in multiple sclerosis patients, said Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) today in reporting the results of a 12-month MRI study on the evolution of multiple sclerosis lesions. The study was published in the January issue of "Frontiers in Bioscience".
“These data indicate that treatment with Copaxone resulted in a measureable amount of tissue repair in study patients,” said the lead research Dr. Robert Zivadinov, Director of the Buffalo Neuroimaging Analysis Center at the University at Buffalo. “The observed increases in magnetization transfer ratio (MTR) point to a potential for remyelination. Overall, these findings contribute to the vast body of research that supports the long-term efficacy and safety of the therapy."
The researchers found that multiple sclerosis patients treated with Copaxone experienced significantly increased magnetization transfer ratio (MTR) - a nonconventional MRI technique used to investigate abnormalities in brain structures, and increased values indicate potential remyelination (re-generation of the nerve's myelin sheath) and axonal tissue repair in the patients' brains.
Teva added that this was the first study to evaluate multiple sclerosis lesions as potential evidence for remyelination in patients treated with Copaxone.
Published by Globes [online], Israel business news - www.globes-online.com - on January 3, 2012
This Blog is intended to provide news and information to people living with MS, their families, caregivers, medical professionals and other stakeholders. Information/opinions contained in this blog are obtained from sources believed to be reliable, but their accuracy cannot be guaranteed. This blogger does not approve, endorse or recommend specific products or services and respects an individual’s right to make their own health management decisions. However, we can provide information to assist people in their decision process. For specific, personalized information, please consult your physician or other health care professional.