Family Members With Multiple Sclerosis Likely To Share Onset Age, But Not Disease Severity

Science Daily — When more than one member of a family is affected by multiple sclerosis (MS), their ages at disease onset are likely to be similar, but disease severity may not be. These new findings have important implications for counseling patients, according to a study published in the January 30, 2007, issue of Neurology®, the scientific journal of the American Academy of Neurology.

"We've known for some time that family influence plays a role in whether you are susceptible to MS, but it has not been clear whether your family influence affects the course of the disease," according to lead study author Alastair Compston, PhD, of the University of Cambridge Clinical School in Cambridge, United Kingdom.

To address the question of family influence on the course of the disease, researchers examined data on 2,310 individuals from over 1,000 families in which at least two members had MS. They examined age at onset, disability, disease severity, and other features of the disease.

The researchers found that age at onset of the disease was similar among family members, whether comparing parents to children or siblings with each other. They also found that siblings tended to have the same pattern of disease progression, while there was no correlation between the pattern in parents and children.

The study also showed there was no correlation between the severity of the disease in one family member and severity in another member, whether siblings or parent and child. "Disease progression is often considered the indicator of severity," said Compston. "But, we found no evidence that disease severity is more likely to be similar between two family members with MS than two unrelated people with MS."

The causes of the similarities in onset and progression pattern are largely unknown, as are the causes of MS itself. It is possible that genetic factors are responsible, but environmental factors shared by family members may also play a role.

Compston says the study's findings have significant implications for counseling patients. "People should not draw personal conclusions for their own MS prognosis and expected disease severity from observing the condition of their relatives with MS," he said.

Note: This story has been adapted from a news release issued by American Academy of Neurology.

Parasites can lessen severity of multiple sclerosis sting

Washington, Jan 19: Multiple sclerosis (MS) is a disease in which the body's own defence cells attack protective nerve tissue, which can cause pain and problems with vision, movement, memory and thinking.

But scientists in Argentina have published a study claiming that these symptoms of the disease may be lessened in people whose immune system has been affected by a parasite.

“Certain types of immune cells, known as T cells, produce chemicals that trigger the crippling attacks of MS. The scientists found that T cells from the parasite-infected patients were less likely to produce these chemicals. Perhaps the parasites programme the T cells to shut down destructive signals,” Nature magazine quoted Jorge Correale of the Raúl Carrea Institute for Neurological Research in Buenos Aires, one of the two scientists who publish today's work, a s saying.Correale has pointed out that his work supports the so-called 'hygiene hypothesis' — the idea that certain infections may teach the body not to attack itself, preventing problems such as allergies.

“Although doctors don't really know what causes multiple sclerosis, environmental factors can play a key role in the disease," Correale said."

Indeed, in Latin America, the prevalence of the disease is significantly lower than in Europe, the United States or Canada. One of the environmental factors that 'protects' the patients could be parasite infections," Correale added.Research in animals has suggested that parasite infections might protect against autoimmune diseases, or those in which the body destroys its own tissues.

If the work holds up, Correale says, the principle may also hold true in other autoimmune conditions such as diabetes and inflammatory bowel disease. Researchers have already tried treating Crohn's disease with so-called 'worm therapy' — dosing patients with a particular gut parasite in order to tweak the immune system2.

Other researchers say that Correale's work is intriguing, but caution that scientists still need to work out which parasites are most likely to help patients before trying worm therapy in other diseases.

Correale has also noted that the doctors who evaluated the patients knew who was infected and who was not — a potential source of bias in the study. And with only 12 patients in each study group, the study is quite small.

Nonetheless, scientists not involved with the work say that the clinical differences between the parasite-infected and non-infected patients looked "dramatic".

"Who knows what's going on in these patients? It's a curious phenomenon." said Ethan Shevach of the US National Institute of Allergy and Infectious Diseases in Bethesda, Maryland.

Bureau Report with ANI inputs

BioMS Medical Cleared By FDA To Initiate Pivotal Phase III Multiple Sclerosis Trial

BioMS Medical Corp (TSX: MS), a leading developer of products for the treatment of multiple sclerosis (MS), announced today that it has received clearance from the United States Food and Drug Administration (FDA) of its Investigational New Drug Application (IND) for the initiation of a pivotal phase III clinical trial to investigate the use of MBP8298 as a treatment for patients with secondary progressive MS."

The clearance to proceed with a phase III trial in the U.S. is a significant step towards bringing MBP8298 to the worldwide market," said Kevin Giese, President and CEO of BioMS Medical. "There are approximately 400,000 Americans with MS and close to 50% of patients have secondary progressive MS. Between the U.S. initiative and the on-going pivotal phase III trial in Canada and Europe, we are successfully executing our global development plan for MBP8298."

The IND allows the commencement of a pivotal phase III secondary progressive MS clinical trial in the US and has been granted on the basis of satisfying FDA criteria regarding preclinical, chemistry, manufacturing and safety data from the completed and ongoing clinical studies for

MBP8298.MAESTRO-03 Phase III US Trial

The pivotal phase III clinical trial in the US, named MAESTRO-03 (A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis), will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

About MBP8298 - Novel Mechanism of Action

In MS patients, the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise "tolerant" of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of "tolerance" to a critical portion of the nerve's Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.

Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.

MAESTRO-01 Trial

The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is currently being conducted at more than 50 sites across Canada and Europe and will enroll approximately 550 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

About Multiple Sclerosis

Multiple sclerosis (MS) is thought to affect as many as 2.5 million people worldwide, including approximately 75,000 in Canada, 400,000 in the United States and over 450,000 in Western Europe. MS is a progressive disease of the central nervous system, characterized initially by episodes of paralysis, blindness, sensory disturbances and cognitive impairment. Almost half of all MS patients have the secondary progressive form of the disease.

Webcast

An audio webcast of Mr. Kevin Giese, President and CEO of BioMS Medical, discussing this release will be available at http://www.biomsmedical.com starting on Monday, January 22, 2007. The replay of the webcast will be available for 90 days at http://www.biomsmedical.com.

About BioMS Medical Corp.BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and it has two pivotal phase III clinical trials for SPMS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally has a Phase II MINDSET-01 trial in Europe for RRMS patients. For further information please visit our website at http://www.biomsmedical.com.

This news release may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

BioMS Medical Corp.
http://www.biomsmedical.com

Rules Should Have Prevented Stem Cell Doctor's Work

The FDA made it clear when it told a Las Vegas doctor he was not following the rules when he began stem cell research on human test subjects.

Eyewitness News has discovered there are rules in place that could have stopped this from happening.

Dr. Alfred Sapse's website clearly states he is interested in testing his stem cell placenta implant on people living with Multiple Sclerosis. And, according to his website, four people with the disease report positive results after receiving the implant.

But the local Multiple Sclerosis Society warns people living with the disease of making hasty decisions when seeking a cure.

The FDA's November letter stating Dr. Sapse did not follow proper clinical procedures also mentions another doctor who got the placenta tissue for the experiment from a local hospital.

One Valley doctor with a Las Vegas Physician's Society says a doctor using human tissue from a hospital must have privileges at that hospital in order to do the research.

Dr. Warren Evins, an internist said, "The hospitals are not in the business of supplying patients' parts to private people. It's only for the use of approved legitimate research for patient benefit."

Elizabeth Keegan, with the National Multiple Sclerosis Society in Las Vegas said MS affects people in very different ways, and that one person might get involved in a clinical trial maybe for reasons very different from another person with the disease.

Keegan said, "When you have this chronic disabling disease you're looking for the answer and people make their choices. And the NMSS standpoint is come to us, let us help you navigate through this system."

While the letter from the FDA is addressed to Dr. Alfred Sapse, it does not name any other doctors working with him, nor does the letter name the hospital where the doctors may be acquiring the stem cell tissue for the implants.

Coverage & Access | Young People Often Serve as Caregivers for Parents With Disabilities, Chronic Illnesses Because of Costs Associated With In-Home H

Daily Health Policy Report
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Coverage & Access Young People Often Serve as Caregivers for Parents With Disabilities, Chronic Illnesses Because of Costs Associated With In-Home Health Care
[Jan 05, 2007]
The Wall Street Journal on Friday examined how young people often serve as caregivers for parents with disabilities and chronic illnesses. According to the Journal, the number of young people caring for parents with debilitating conditions -- such as Lou Gehrig's disease, multiple sclerosis, lupus, cancer and heart disease -- is "large and expected to grow" as advances in medicine and technology allow people with such conditions to live longer. A 2005 study funded by the U.S. Administration on Aging and conducted by the National Alliance for Caregiving and the United Hospital Fund Foundation found that as many as 1.3 million to 1.4 million children in the U.S. ages eight to 18 provide care for a family member with a chronic illness or disability, and more than 400,000 child caregivers are younger than age 12. The study, based on a two-part survey that included a random sampling of 2,000 households and follow-up interviews with children and other family members, found that nearly 60% of child caregivers helped their family members bathe, dress or eat. About 25% of the children had no help with such tasks, and about half said caregiving took a significant amount of their time, the study found. In addition, the study found that about 60% of the children came from households that earned less than $50,000 per year, according to the study. According to the Journal, few of the families can afford in-home health care, which costs about $140 to $180 per day, and most private insurance plans do not cover such services. The Journal reports that the children "often have little choice" in providing care because many "live in single parent homes, with only the infirm parent" and in two-parent homes, the healthy parent might be working. However, "[p]lacing so much responsibility on young people can end up being costly," the Journal reports. Nancy Law of the National Multiple Sclerosis Society said, "If a family breaks apart because the burden becomes too much for a child, you're talking about two institutional placements: The parent in a nursing home and the child in the foster-care system" (Ansberry, Wall Street Journal, 1/5).

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=41967

Eye center detecting MS in early stages

HOUSTON, TX, United States (UPI) -- Doctors in Houston are looking into their patients` eyes to search for early signs of multiple sclerosis.
Using four different and inexpensive eye exams, physicians at the Multiple Sclerosis Eye Center for Analysis, Research and Education search for abnormalities in the retina and damage to optic nerve fibers. Many doctors agree that, in more than half of patients, the neurological disorder first attacks the eyes, causing blurred vision, and temporary or permanent sight loss, the Wall Street Journal said Tuesday.
By concentrating on the eyes, 'the center is helping patients identify irregularities and referring them for treatments that may slow the disorder`s progression,' says Rosa Tang, co-director at MS Eye Care.
No one test can either diagnose or eliminate MS, doctors said. Several tests, such as an MRI or a spinal tap, both expensive, are needed for a thorough diagnosis.
A number of doctors are pushing for more centers similar to MS Eye Care, based on its capability of early detection at a lower cost.
Copyright 2007 by United Press International