By: National Multiple Sclerosis Society on May 24 2006 08:13:26

Early Treatment for Multiple Sclerosis
http://www.emaxhealth.com/7/5992.html
An editorial accompanying a published debate on the pros and cons of starting treatment early in the course of multiple sclerosis comes down in favor of early treatment for this potentially devastating disease. This opinion coincides with a consensus paper published by the National Multiple Sclerosis Society. The April issue of the Archives of Neurology features both sides of this debate on early treatment for Multiple Sclerosis.

Background: Currently five therapies are approved by the U.S. Food and Drug Administration for the treatment of multiple sclerosis. These agents can reduce future disease activity for many individuals with relapsing forms of Multiple Sclerosis, including those with secondary progressive disease who continue to have relapses. The National MS Society's Medical Advisory Board recommends that initiating MS therapy with an immunomodulating drug (such as FDA-approved interferons or glatiramer acetate) should be considered as soon as possible following a definite diagnosis of Multiple Sclerosis with a relapsing course, and for selected patients with a first attack who are at high risk for MS. Some clinicians disagree, however, choosing to defer treatment until the extent of disease activity is more clearly established.

The Debate: E. M. Frohman, MD, PhD (University of Texas Southwestern Medical Center at Dallas) and an international panel of coauthors present the following arguments in favor of early treatment in an article titled, "Most Patients with Multiple Sclerosis or a Clinically Isolated Demyelinating Syndrome Should Be Treated at the Time of Diagnosis" (Archive of Neurology 2006;63:614-619):

* Most who have Multiple Sclerosis will develop significant disability over time, and when MS is initially diagnosed, it is impossible to determine whether its course will be disabling or benign (mild course of disease).

* Studies show that injury to nerve fibers – which leads to the progression of disability that can occur in people with Multiple Sclerosis – begins early in the course of the disease. Even if a person appears to be doing well, with few clinical relapses, there may be evidence on MRI of tissue damage and loss that is associated with eventual disability.

* The approved agents decrease the number and severity of relapses, the number and size of new lesions (areas of damage to nerve-insulating myelin), and progression of disability. These treatments work best early in the course of Multiple Sclerosis, and do not work as well during progressive stages.

* Delaying treatment has been associated with more progression of disability and a larger volume of disease damage as seen on MRI.

The authors conclude that, given that therapies can significantly reduce MS disease activity, then "almost every" patient early in the course of MS should be offered disease-modifying therapy.

On the other hand, Sean J. Pittock, MD, and colleagues (Mayo Clinic, Rochester, MN) cite the reasons for delaying treatment until the course of MS becomes more apparent in an article titled, "Not Every Patient with Multiple Sclerosis Should Be Treated at Time of Diagnosis" (Archives of Neurology 2006;63:611-614):

* If left untreated, Multiple Sclerosis often runs a "favorable" course, but it becomes difficult to distinguish a favorable course from treatment success if people are treated for a long time.

* The approved treatments are only partially effective in the short-term; it has not been proven that they can prevent long-term disability.

* Drawbacks to treatment include the cost, adverse effects, neutralizing antibodies (immune system proteins that can interfere with the effectiveness of interferons), and some patients' reluctance to make a long-term commitment to taking injected medications.

The authors suggest that monitoring people with Multiple Sclerosis regularly with clinical examinations and MRI scans may help to identify people whose course requires treatment with disease-modifying therapies. They conclude that well-designed studies are required to determine whether early, versus delayed, treatment of relapsing MS makes a clinically meaningful difference in terms of the development of disability.

In an accompanying editorial, E. S. Roach, MD (Wake Forest University School of Medicine, Winston-Salem, NC) comments on the two reports and concludes in favor of early treatment (Archives of Neurology 2006;63:619).

"One approach, as proposed by Pittock and colleagues, is to defer treatment until the patient's course is better established, possibly allowing those with less aggressive disease to avoid years of unnecessary treatment," comments Dr. Roach. "But as Frohman and colleagues counter, most people with newly diagnosed MS do progress, and we must consider that treatment could be less effective if started later in the course of the illness."

Dr. Roach notes the necessity for finding specific evidence that some people do not need treatment. "Without such evidence for individuals with Multiple Sclerosis, it will be difficult to know for sure whether it is ever safe to defer treatment," he concludes. "While it would be wonderful if we could avoid treating some patients with Multiple Sclerosis, until we can distinguish these individuals from the others, it is probably better to offer treatment to all patients except in the setting of a clinical trial."

Toronto, May 24, 2006 – The Multiple Sclerosis Society of Canada  announced findings from a Canadian study that shows the risk of MS may be influenced by place of residence during childhood rather than ancestry. The study results were published in a recent edition of Neuroepidemiology.

The study puts into question the belief that MS is a disease targeted primarily at Caucasians or those with ancestral ties to areas north of the equator such as Northern Europe.

The study involved 44 children and 573 adults from the paediatric MS clinic at the Hospital for Sick Children and the adult MS clinic at St. Michael’s Hospital, both located in Toronto.

“By comparing study results with census data, we found that the MS population has become more multicultural as immigration to Ontario has increased,” explains Dr. Brenda Banwell, director of the paediatric MS clinic at the Hospital for Sick Children and principal investigator for the study. “This adds great credence to our theory that childhood
residence, more than ancestry, is a major determinant of MS risk.”

The adult MS clinic population examined showed most of the patients,upwards of 90 percent, reported European heritage. Data from the 1971 census, obtained when most of the adult MS patients were growing up in Ontario, showed 84 percent of residents of Ontario were of European ancestry.Meanwhile, paediatric MS patients were more likely to report Caribbean,
Middle Eastern or Asian ancestry, accurately mirroring the population shift as detailed by the 2001 census.

“The common thread in all of this is that 100 percent of the paediatric population and 79 percent of the adult population grew up in Ontario,” says Dr. Banwell. “This, combined with the ancestry data, suggests a prevailing influence of environment on MS risk.”According to the MS Society, this is an important study because the relative contributions of ancestry, country of birth and residence as determinants of MS risk have never been explored in the paediatric MS
population.“The change in immigration patterns, and the presence of well-established paediatric and adult MS programs, provided researchers with the unique opportunity to evaluate these factors as determinants of MS risk,” says Dr. William J. McIlroy, national medical advisor for the MS Society of Canada. “The more complete a picture we can paint of MS
and its risk factors, the closer we will be to finding the cause, and ultimately, the cure.”
The study was funded by the MS Scientific Research Foundation which receives the majority of its funding from the MS Society of Canada.

http://www.todmaffin.com/blogs/ms/2006/05/28/multiple-sclerosis-risk-influenced-by-childhood-environment/

MS Centers of Excellence

Take Action!

The Veterans Affairs – Multiple Sclerosis Centers of Excellence (MSCoE) have made significant contributions in the fight against MS. Since 2003, the MSCoE have provided leadership in research, education and clinical care that benefit all Americans impacted by MS.

The MSCoE, established by the VA, are located in Baltimore (East), and Seattle/Portland (West). The benefit of the MSCoE reaches throughout the country by providing service to 38 VA clinics in the United States.

Unfortunately, the existence of the MSCoEs is in jeopardy because of competing demands for funding within the VA.

S. 1537, introduced by Sen. Akaka, would help protect the MSCoE by formally establishing the Centers through Congressional action. The bill has been introduced in the Senate Veterans’ Affairs Committee and is expected to be considered by the full Senate as early as June.

The MSCoE support a range of programs including:

* Basic research into the causes of MS
* Clinical research into the treatment of MS
* Behavioral research about effective education strategies for MS patients and providers
* Population level research into the needs of MS patients and the effectiveness of the care delivery system
* Development of a national educational program which has significantly enhanced education related to MS patients who are veterans, caregivers and providers
* Development of a national program to enhance the clinical care of veterans with MS by providing improved access to subspecialty care
* The support of regional MS clinics that direct the care for nearly one-third of veterans systems users with MS

Contact your Senator and ask them to co-sponsor S. 1537 and protect the MSCoE and the work they do to help end the devastating effects of MS.

MS Centers of Excellence

Take Action!

http://capwiz.com/nmss/issues/alert/?alertid=8795231&queueid=[capwiz:queue_id]

<>Biogen Idec Inc. (SYMB:BIIB) is another fund holding, but Cuggino rates its outlook "murkier" largely because of the company's recalled multiple sclerosis drug Tysabri.

"We're not aggressively adding or selling off the stock at this time," Cuggino said.

Before it was pulled, Tysabri was expected to earn upwards of $2 billion a year. The drug was co-developed with Irish drugmaker Elan Corp. Plc (SYMB:ELN).

Biogen pulled the promising Tysabri from the market in the spring of 2005 over concerns that it was triggering a rare brain disorder. The FDA is expected to rule by the end of June on whether to allow the product back on the market and in what capacity. Most analysts expect a ruling in the company's favor.

Meanwhile, Cuggino noted, Biogen's flagship product, the multiple sclerosis drug Avonex, has been facing increased pricing pressure and competition, which could further burden the stock.

"But they're not sitting there," Cuggino said. The company is moving to fill its product pipeline, he added, and "trying to come up with alternatives if it turns out that Tysabri isn't a blockbuster."

Because of Tysabri, Biogen's true market value is difficult to gauge, said Cuggino. If Tysabri is ultimately successful, there could be a "surprise upside" to the stock, he added.

On Friday, shares of Biogen Idec added 1 cent to $47.

Originally published on May 29, 2006

http://www.nydailynews.com/business/marketwatch/story/421931p-356183c.html

Elan says aims for clarity on Tysabri by June 28
Reuters - USA
(ELN.I: Quote, Profile, Research) said on Thursday it was still aiming for clarity on the future of its multiple sclerosis drug Tysabri by the end of June. ...

Elan still aims for June Tysabri deadline
RTE.ie - Ireland
Elan said today that it was still aiming for clarity on the future of its multiple sclerosis drug Tysabri by the end of June. Speaking ...

http://emeryneuro.com/multiple_sclerosis.htm
Overview:

Multiple Sclerosis (MS) is a common disabling neurologic disorder of young adults, affecting at least 300,000 Americans. The average age of diagnosis is 30, but it typically starts anywhere between the ages of 15 and 50. Occasionally, the disease begins in children or in older adults. Women are affected at least twice as often as men. It is more common in persons of Northern European heritage, and people with MS are distributed in a remarkable geographic pattern. The highest density occurs in those living furthest from the equator, that is, in temperate zones.

The picture on the right is an MRI of the spine and the arrows shows MS lesions.

There are several types of MS. Most people with MS begin with relapsing remitting disease-that is, it starts with an abrupt onset of neurological problems like numbness or tingling, weakness, or unsteady gait, that either improve spontaneously, visual disturbances or with treatment of the symptoms-only to come back again or "relapse." Until recently, when the first treatment became available, most people with relapsing remitting MS eventually developed a secondary or chronic progressive from of the disease. Ultimately, over one half of people with MS will experience a progressive course.

In general, MS is not life threatening. The life expectancy of those with MS is only slightly less than the general population. When premature death occurs, it is usually the result of complications such as pneumonia or other infections.

The disease is not contagious, and its course is very unpredictable. There is tremendous variation between patients and in patients in various stages of the disease

What Is Multiple Sclerosis? Multiple sclerosis (MS) is thought to be an autoimmune disease, which means that your own immune system mistakenly attacks normal tissues in your body. In MS, these attacks are aimed at the brain and spinal cord, or the central nervous system. The central nervous system is made up of nerves that act as the body's messenger system. Each nerve is covered by a fatty substance called myelin, which insulates the nerves and helps in the transmission of nerve impulses, or messages between the brain and other parts of the body.

MS gets its name from the buildup of scar tissue located in more than one area of the brain and/or spinal cord. Plaques form when the protective myelin sheath is destroyed, a process called demyelination. Without the myelin, signals transmitted throughout the central nervous system are disrupted or halted. The brain then becomes unable to send and receive messages. Although the nerves can regain myelin, this process is not fast enough to outpace the deterioration that occurs. The types of symptoms, severity of symptoms, and the course of MS vary widely, partly due to the location of the scar tissue and the extent of demyelination. What causes multiple sclerosis? There is no known cause of MS; the disease is probably related to a number of factors. While symptoms show up in the central nervous system, MS appears to be the result of problems in the immune system. The ultimate consequence of MS is that immune cells enter the brain and spinal cord, attack the myelin and eventually cause myelin loss and scarring. The entire process results in the failure of nerve impulses to be sent or received properly. How does MS progress? The course of multiple sclerosis varies for each person. Because of this, people are told by their doctor that they "probably" or "possibly" have MS. Your diagnosis is based on the combination of problems, patterns of recurrence, which systems are impaired, and your lab results. There is no way to predict how each person's condition will progress. Four basic types of MS have been defined: Relapsing-remitting: characterized by acute attacks, called exacerbations, followed by full recovery or some neurological symptoms after recovery. The disease does not worsen in the periods between relapses. Primary progressive: characterized by a gradual but steady progression of disability, without any obvious relapses and remissions. Secondary progressive: initially begins with a relapsing-remitting course, but later evolves into progression at a variable rate. Progressive relapsing: characterized by a steady progression in disability with acute attacks that may or may not be followed by some recovery. What does my future hold? One of the greatest challenges of MS is the unpredictability and uncertainty of what is to come. A good plan for coping with your concerns about the future is to: Educate yourself about possible changes. Work with your doctor and other healthcare professionals to manage your symptoms. Communicate openly with your family and others. Keep your life satisfying and fulfilling. How Is MS Diagnosed? There is no single diagnostic test that is proof-positive for multiple sclerosis. There is a set of accepted criteria for MS diagnosis, but even this system is imperfect. Since diagnosing MS can be very difficult, it must be done by a neurologist who specializes in treating MS. As many as 10% of people diagnosed with multiple sclerosis actually have some other condition that mimics MS. Examples of other conditions that masquerade as MS include inflammation in the blood vessels, multiple strokes, vitamin deficiency, or brain infection. Sometimes stress-related disorders can lead to a misdiagnosis of MS. What are the accepted criteria for diagnosis? Onset usually between 10 and 60 years of age Symptoms and signs indicating lesions of central nervous system white matter Evidence of two or more lesions upon examination by MRI scan Objective evidence of central nervous system disease on neurological examination A course following one of two patterns: two or more episodes lasting at least 24 hours and occurring at least one month apart, or a progressive course of signs and symptoms over at least six months No other explanation for the symptoms How will I be diagnosed? An accurate diagnosis is based on your medical history and neurological examination using tests of nervous system function or MRI. A lot depends on the skill of the physician in asking the right questions to uncover information and to properly evaluate the signs and symptoms of a malfunctioning nervous system. In addition to a thorough medical history and neurological examination, a variety of specialized procedures are helpful -- although not always necessary -- in accurately diagnosing MS. These include imaging techniques such as MRI, spinal taps (examination of the cerebrospinal fluid that runs through the spinal column), evoked potentials (electrical tests to help determine if MS has affected a person's sensory nerve pathways), and laboratory analysis of blood samples. What does an MRI show? The precise image produced by magnetic resonance imaging (MRI) gives the neurologist clear evidence of scar tissue in the deep parts of the brain or spinal cord that is characteristic of MS. However, abnormal spots on the brain MRI can be caused by other conditions, so these images must be interpreted by the neurologist in light of all information about the patient. Similar lesions can be seen in elderly people or people with migraine headaches or high blood pressure. Confirming a diagnosis of MS and ruling out other possible causes requires expert interpretation of the MRI scan. Will I need a spinal tap? Performing a spinal tap to examine the cerebrospinal fluid may be helpful in diagnosing MS in some people, but it is no longer considered necessary in all instances. An experienced MS team will be able to determine if you need this test to confirm a suspected diagnosis of MS, particularly if your history and physical examination suggest the presence of the disease. Abnormalities that may appear in the cerebrospinal fluid can be very helpful in establishing a diagnosis but, like other tests, spinal taps are not foolproof in diagnosing MS. What other tests might be done? Electrical tests of the nerve pathways, known as evoked potentials, are very helpful in confirming whether MS has affected the visual, auditory, or sensory pathways. These tests are done by placing wires on the scalp to test the brain's response to certain types of stimulation, such as watching a pattern on a video screen, hearing a series of clicks, or receiving electrical impulses in your arm or leg. Your doctor may order a blood test to help rule out conditions that imitate multiple sclerosis, but the presence of MS cannot be detected in the blood. Treatment There is no known cure for multiple sclerosis, but there are many types of treatments. The interventions prescribed by your doctor and other healthcare professionals are not designed to make MS disappear. Instead, the various treatments -- including medications, exercises, adaptive aids, and self-care strategies -- are designed to help manage symptoms, prevent unnecessary complications, control disease progression, and minimize disability. The medical management of your MS involves an ongoing collaboration between you and your healthcare team. Decisions about treatment must be made on an individual basis. The treatment of MS can be grouped into three categories: disease-modifying treatments, management of acute attacks, and management of symptoms. Stress and MS Multiple sclerosis is an unpredictable, frustrating disease. As such, its emotional impact can be as great as its physical impact. The prolonged stress of living with a chronic illness can lead to frustration, anger, hopelessness and, at times, depression. People with multiple sclerosis are especially at risk for becoming depressed. And you are not the only person affected. Family members are also influenced by the persistent health changes of a loved one. It is important to recognize the triggers, signs and solutions that are associated with stress so that you can effectively manage it. What causes stress for people with MS? Uncertainty of diagnosis (living with symptoms and no diagnosis) Unpredictability of the disease The emergence of symptoms and having visible signs of the disease, such as the need of a cane or wheelchair Concerns about finances and job situation Having to depend on others, and not being able to care for others (such as spouses and children) like you used to Modifying your activities and your surroundings to accommodate your MS Symptoms that are unexplainable and not understandable What are the warning signs of stress? Your body sends out physical, emotional, and behavioral warning signs of stress. Emotional warning signs include anger, an inability to concentrate, unproductive worry, sadness, and frequent mood swings. Physical warning signs include stooped posture, sweaty palms, chronic fatigue, and weight gain or loss. Behavioral warning signs include overreacting, acting on impulse, using alcohol or drugs, and withdrawing from relationships. What can I do to reduce stress? Keep a positive attitude. Accept that there are events that you cannot control. Be assertive instead of aggressive. Assert your feelings, opinions, or beliefs instead of becoming angry, combative, or passive. Learn relaxation techniques. Exercise regularly. Your body can fight stress better when it is fit. Eat well-balanced meals. Rest and sleep. Your body needs time to recover from stressful events. Don't rely on alcohol or drugs to reduce stress.

Last Update: 9:01 AM ET May 25, 2006

DUBLIN (MarketWatch) -- Elan Corp. PLC's (ELN) Chief Executive Kelly Martin said Thursday there is future "headroom" to raise the price of multiple sclerosis drug Tysabri after its anticipated return to the market in the U.S.

The U.S. Food & Drug Administration will make a final decision on Tysabri's re-entry by June 28, and most analysts see it back on the market in the U.S. in the third quarter of 2006.

"Clearly there's headroom and a business legitimacy for one to raise the price," Martin told a press briefing after the company's annual general meeting, adding the issue will be discussed with Elan's Tysabri partner Biogen Idec Inc. (BIIB).

Martin said: "We would need to see the final labeling and risk management dynamic before making any decisions on price." These details are currently being finalized by Elan and Biogen with the FDA, he added.

When the two companies temporarily suspended sales of the drug in the U.S. last year on safety concerns, patients were being charged $23,500 for 13 infusions a year, or 1 every 4 weeks.

Elan has repeatedly said it expects Tysabri to be reintroduced to the market and the MS drug could break even with around 20,000 patients, though the company expects to surpass this figure easily.

Martin said there are over 2.5 million MS sufferers worldwide and, although he wouldn't be drawn on specific figures, he said that Tysabri will play a "very substantial role" in the existing global market.

"We haven't predicted that (the market share) yet," he said, "but 70% of MS patients are declining clinically. When new products are introduced to an existing market, volatility increases and people tend to use the new technology."

Martin said it would be "premature" to make more accurate predictions, but added the company would be in a better position to make forecasts when Tysabri has been back on the U.S. market for at least two months.

He reiterated Tysabri's 68% reduction in MS relapses, compared with 30% for existing therapies and said this is the kind of data that will be highlighted in relation to labeling Tysabri in E.U. countries when the time comes.

The European Medicines Agency's advisory committee has recommended Tysabri be used in the E.U. only as a treatment for relapsing multiple sclerosis patients; the agency's decision is due sometime this summer.

And the U.S. Food & Drug Administration's advisory committee has advised that Tysabri be reintroduced as a monotherapy in the U.S., a first-line treatment for all MS sufferers.

Elan and partner Biogen Idec Inc. (BIIB) suspended their would-be blockbuster drug in the U.S. on February 28 last year after three patients on combination therapy - including Tysabri -contracted a rare neurological disease called PML.

Company Web site: http://www.elan.com
-Contact: 201-938-5400 End of Story

http://www.marketwatch.com/News/Story/Story.aspx?dist=newsfinder&siteid=google&guid=%7BFA6527E4-297F-416E-8F88-5AEDC8C2E5EC%7D&keyword=

Pros and cons of starting multiple sclerosis treatment early
News-Medical-Net Tue, 23 May 2006 5:05 PM PDT
An editorial accompanying a published debate on the pros and cons of starting treatment early in the course of multiple sclerosis comes down in favor of early treatment for this potentially devastating disease.
Early treatment favored for multiple sclerosis
EurekAlert! Tue, 23 May 2006 3:00 PM PDT
Most who have MS will develop significant disability over time, and when MS is initially diagnosed, it is impossible to determine whether its course will be disabling or benign (mild course of disease).

The Immune Response Corporation Retains ROI Group Associates as ...

PharmaLive.com (press release) - Newtown,PA,USA
... "As part of our new strategy, we are focusing on our immune-based therapeutic candidates, NeuroVax(TM) and IR103, which are both in Phase II clinical trials. ...

Another study of Tysabri, which included 2,248 patients with either Crohn's disease, multiple sclerosis or rheumatoid arthritis, found the risk of developing the PML brain infection was very low, according to Dr. William Sandborn of the Mayo Clinic, who led the study. Before the voluntary recall of the drug, three patients were identified with the infection, and four more infections were initially reported in post-marketing reviews. Sandborn's analysis, in which his team checked spinal fluid and blood, found no additional cases among the patients studied, and the four post-marketing cases did not have the infection after all.
http://www.forbes.com/forbeslife/health/feeds/hscout/2006/05/23/hscout532863.html

BY DONNA GEHRKE-WHITE

dgehrke@MiamiHerald.com

MORIS MORENO

'I ENJOY LIFE': Former model Wendy Crawford, who is a quadriplegic, does outreach work for people with disabilities.

• Visiting the exhibit | Uncensored Life -- Raw Beauty
• Video | Slideshow of photos from exhibit

They are usually ignored.

Until now.

In a Miami gallery, the disabled women are larger than life, displayed in portraits splashed on white-washed gallery walls, nude on the beach or giving a come-hither look while perched on a stainless steel wheelchair.

One woman playfully dons black wings while another pretends to be a silent-movie damsel in distress, tied to the railroad tracks as a train approaches.

In all, 20 women with disabilities bare their souls -- if not their bodies -- for a new exhibit, Uncensored Life -- Raw Beauty at the Dorsch Gallery in Miami. The exhibit includes photographs, poems, mini-biographies and quotes from South Florida women who were born with cerebral palsy, spina bifida or are paralyzed, blind or deaf.

''I always thought this would be a great idea,'' says Wendy Crawford, 41, a former model whom a drunk driver left a quadriplegic when she was 19.

She fit her sensuous wheelchair-pose photography session into an already busy schedule of fundraising and outreach work for people with disabilities. She also scuba dives and swims.

''I enjoy life,'' she says. ``Being depressed gets boring after a while.''

She and others want to show a side of themselves not usually noticed by others.

POETRY, TOO

Quadriplegic Marjorie Layne Burnett, 39, bared her body on a South Florida beach and wrote a poem for the exhibit that included the lines:

``I am sexual

Just take a look

Open your eyes wide

See the real me.''

''These women are gorgeous,'' says Ginny Dixon, a photographer who shared in two Pulitzer Prizes while at The Los Angeles Times. She led the project and photographed six of the women, including one who can move only her neck. Miami Ad School photographers also donated their time as photographers.

''It's one of the best things I have ever participated in,'' Dixon says.

Dr. Susan Solman, a 44-year-old podiatrist and pharmacist who owns her own healthcare business, posed for Dixon, smiling in a sensuous above-the-chest nude shot.

''I have finally learned how to embrace who I am,'' says Solman, who became a paraplegic five years ago after suffering a tumor on her spinal cord.

LEARNING EMPATHY

''I have learned what it is like to be weak and vulnerable, which has taught me empathy and compassion,'' she wrote in her bio for the exhibit.

Her friend, Rochelle Baer, 42, who has rheumatoid arthritis, persuaded her to be part of the project.

Baer at first thought of creating and selling a calendar of nude disabled women to help raise money for the Center for Independent Living, an agency that offers independent living, job placement and other free services to the disabled.

SPORTSWOMEN

But then the project expanded into not only photographing the women's sensuality but also their empowerment. The women are doctors, artists, social workers and business owners. They participate in all sorts of sports.

Shanti Nair, 39, who was born with spina bifida, is photographed sailing by herself on Biscayne Bay.

Her parents had been afraid for her when she moved from India to South Florida.

But she knew she had to leave to enjoy a more active life. Buildings in the United States are much more accessible to the handicapped than in her native India, she wrote in her biography for the exhibit.

Then there's Adina Beth, 30. She rides her Harley -- and horses. Dixon photographed her nuzzling a horse. Beth also barrel races and gardens.

She has learned to use her deafness to her advantage. ''When I don't want to hear what people are saying, I just turn off my cochlear implant,'' she jokes in her bio.

Another model, Joy Nabors, 33, is photographed dancing in a wheelchair. Multiple sclerosis may keep her in the wheelchair, she says, ``but I am flying high as a kite when I dance.''

http://www.miami.com/mld/miamiherald/living/health/14617084.htm?source=rss&channel=miamiherald_health

MARKETMOVERS : Irish stocks not immune to global shake-out

Irish Independent - Dublin,Ireland
Pharma company Elan rose by a very healthy 18pc on fresh speculation of an imminent approval for Tysabri. Elan stood out as a share which performed well. ...

Elan Corp. Chugs Higher on Tysabri Strength
Ant & Sons - USA
... neurodegenerative diseases. On the strength of its main drug for multiple sclerosis Tysabri, Elan continues to chug higher. On Friday ...

No health insurance? Program tries to fill gaps The Palm Beach Post Sun, 14 May 2006 9:27 PM PDT For two years, Maria Cruz's health kept getting worse, with increased headaches, coordination loss and vision problems. Her declining health was making her life miserable.

The puzzle of ME moves a little closer to being solved
Daily Telegraph Mon, 15 May 2006 5:44 AM PDT
Could a reduction in grey matter be to blame for Chronic Fatigue Syndrome? Barbara Lantin reports.

The Immune Response Corporation to Present at Rodman & Renshaw ...

Genetic Engineering News - Larchmont,NY,USA
... Mr. Green will discuss Immune Response's drug development pipeline and status of the Phase II clinical trials now in progress for NeuroVax(TM) for the ...
See all stories on this topic

9th Annual Race To Erase MS Dinner
At the 9th Annual Race To Erase MS Dinner, Century Plaza Hotel, Century City, 05-10-02

http://www.dailyceleb.com/production/index.php?view=event&eid=726

http://www.medicalnewstoday.com/medicalnews.php?newsid=43159&nfid=rssfeeds

Article Date: 14 May 2006 - 3:00am (PDT)

A new way to preserve the cells that surround and protect nerves could lead to new treatments for demyelinating diseases such a multiple sclerosis, a research team reports in the May 2006, issue of the Journal of Neuroscience.

The approach grew out of a novel explanation, quickly gaining followers, for the mechanism of nerve damage caused by multiple sclerosis. Instead of concentrating on the alterations that result in autoimmune assaults on the nervous system, researchers led by Brian Popko of the University of Chicago have focused on a set of factors that prevent recovery from the inflammatory attacks.

A series of papers from Popko's lab has demonstrated that interferon-gamma -- a chemical signal used to activate the immune system -- plays a critical role in damaging the cells that produce myelin, the protective coating that lines healthy nerves. Interferon not only leaves these cells, called oligodendrocytes, incapable of repairing the damage but can also kill them directly.

"Interferon-gamma is not normally found in the nervous system," said Popko, the Jack Miller Professor of Neurological Diseases at the University of Chicago, "but it can gain entry after an inflammatory flare-up. We previously showed how it harmed oligodendrocytes. Here we confirm its direct harmful effects on those cells and demonstrate one way of protecting them."

The researchers produced a series of transgenic mice. In one set they introduced genes that produced interferon-gamma within the central nervous system. In another set they also introduced a gene (known as suppressor of cytokine signaling 1, or SOCS1) that blocked the response of myelin-producing cells to interferon-gamma.

Although transgenic mice with low levels of interferon-gamma showed no symptoms of nervous system damage, 18 out of 20 mice exposed to higher interferon levels developed difficulty walking, including mild to moderate tremors, within two weeks of birth. Only four out of 20 mice with both high interferon levels and the SOCS1 gene had symptoms.

On autopsy, mice with high interferon levels in the nervous system had severe loss of oligodendrocytes, ranging from 20 to 40 percent. Those with the protective SOCS1 gene lost only eight to 15 percent.

High interferon levels were also associated with loss of myelin sheaths around nerve connections and unprotected axons in the brain. Again, SOCS1 was able to reduce the damage.

"Together," the researchers wrote, "these data demonstrate that oligodendroglial expression of SOCS1 protects mice from the clinical and morphological consequences of IFN-gamma expression in the central nervous system during development."

"We found this tremendously encouraging," said Popko. "SOCS1 prevented or reduced the harmful effects of interferon gamma on myelin-producing cells. This study solidifies our suspicions about interferon's specific role in demyelinating disease and suggests ways to block it."

Although there is currently no reliable way to deliver SOCS1 directly to the nerves of a patient with multiple sclerosis, this protective approach could be combined with stem cell therapy to repair nerve damage. Several research groups are already studying the use of stem cells to repair damaged myelin sheaths, but in the long term those stem cells would be vulnerable to ongoing immune-mediated damage.

But if stem cells could be engineered to resist harmful signals such as interferon-gamma, they might be protected from the "harsh environment" present in immune mediated demyelinated lesions, said Popko.

###

The National Institutes of Health and the Myelin Repair Foundation supported the research. Additional authors include Roumen Balabanov and Ji Yeon Lee of the University of Chicago, Krystal Strand of the University of North Carolina, and April Kemper of Wake Forest University.

Contact: John Easton
University of Chicago Medical Center

http://www.medicalnewstoday.com/medicalnews.php?newsid=43159&nfid=rssfeeds

Article Date: 14 May 2006 - 3:00am (PDT)

A new way to preserve the cells that surround and protect nerves could lead to new treatments for demyelinating diseases such a multiple sclerosis, a research team reports in the May 2006, issue of the Journal of Neuroscience.

The approach grew out of a novel explanation, quickly gaining followers, for the mechanism of nerve damage caused by multiple sclerosis. Instead of concentrating on the alterations that result in autoimmune assaults on the nervous system, researchers led by Brian Popko of the University of Chicago have focused on a set of factors that prevent recovery from the inflammatory attacks.

A series of papers from Popko's lab has demonstrated that interferon-gamma -- a chemical signal used to activate the immune system -- plays a critical role in damaging the cells that produce myelin, the protective coating that lines healthy nerves. Interferon not only leaves these cells, called oligodendrocytes, incapable of repairing the damage but can also kill them directly.

"Interferon-gamma is not normally found in the nervous system," said Popko, the Jack Miller Professor of Neurological Diseases at the University of Chicago, "but it can gain entry after an inflammatory flare-up. We previously showed how it harmed oligodendrocytes. Here we confirm its direct harmful effects on those cells and demonstrate one way of protecting them."

The researchers produced a series of transgenic mice. In one set they introduced genes that produced interferon-gamma within the central nervous system. In another set they also introduced a gene (known as suppressor of cytokine signaling 1, or SOCS1) that blocked the response of myelin-producing cells to interferon-gamma.

Although transgenic mice with low levels of interferon-gamma showed no symptoms of nervous system damage, 18 out of 20 mice exposed to higher interferon levels developed difficulty walking, including mild to moderate tremors, within two weeks of birth. Only four out of 20 mice with both high interferon levels and the SOCS1 gene had symptoms.

On autopsy, mice with high interferon levels in the nervous system had severe loss of oligodendrocytes, ranging from 20 to 40 percent. Those with the protective SOCS1 gene lost only eight to 15 percent.

High interferon levels were also associated with loss of myelin sheaths around nerve connections and unprotected axons in the brain. Again, SOCS1 was able to reduce the damage.

"Together," the researchers wrote, "these data demonstrate that oligodendroglial expression of SOCS1 protects mice from the clinical and morphological consequences of IFN-gamma expression in the central nervous system during development."

"We found this tremendously encouraging," said Popko. "SOCS1 prevented or reduced the harmful effects of interferon gamma on myelin-producing cells. This study solidifies our suspicions about interferon's specific role in demyelinating disease and suggests ways to block it."

Although there is currently no reliable way to deliver SOCS1 directly to the nerves of a patient with multiple sclerosis, this protective approach could be combined with stem cell therapy to repair nerve damage. Several research groups are already studying the use of stem cells to repair damaged myelin sheaths, but in the long term those stem cells would be vulnerable to ongoing immune-mediated damage.

But if stem cells could be engineered to resist harmful signals such as interferon-gamma, they might be protected from the "harsh environment" present in immune mediated demyelinated lesions, said Popko.

###

The National Institutes of Health and the Myelin Repair Foundation supported the research. Additional authors include Roumen Balabanov and Ji Yeon Lee of the University of Chicago, Krystal Strand of the University of North Carolina, and April Kemper of Wake Forest University.

Contact: John Easton
University of Chicago Medical Center

Teri Garr (11/9/05)

Watch the Interview | More

http://www.pbs.org/kcet/tavissmiley/special/roadtohealth/archive/#

Companies Educate People About Tysabri

CBS News - USA
(AP) It was barely two hours after a panel recommended to the Food and Drug Administration that it allow the drug Tysabri back on the market when Dr. Joseph ...

BOSTON--(BUSINESS WIRE)--July 26, 2004--

Company plans to initiate human Phase I study with Axosine therapy previously shown to stimulate brain re-wiring and to enhance motor function recovery after stroke in animals

Boston Life Sciences, Inc. (NASDAQ: BLSI) announced that the Company has filed an Investigational New Drug (IND) application with the FDA for the use of Axosine(TM) to enhance motor function recovery after stroke. The IND includes a proposed human Phase I study protocol to test the safety of Axosine administered to stroke patients for 28 days by continuous infusion into one of the fluid compartments of the brain (intracerebral ventricle; ICV). Pre-clinical efficacy and safety animal testing has shown that Axosine, when administered in this manner, is safe, well-tolerated, and highly effective in promoting motor function recovery after experimentally-induced strokes in rats. The results of these efficacy studies, as well as studies demonstrating compensatory axon growth in experimental spinal cord injury, have been published in numerous prestigious scientific journals during the last few years. The Company believes that Axosine is the first in a class of small molecule (nonpeptide) axonal growth factors to enter commercial clinical development for this indication. The Company hopes to initiate its Phase I study following a 30 day FDA review of the IND, although the Company cautions that the FDA may have questions or concerns that require a response or additional preclinical studies to be performed prior to initiating the Phase I study.

The proposed Phase I study has been designed to enroll 27 moderate-severe stroke patients in up to 3 academic stroke centers in the greater Boston area. The study design calls for a dose-escalation of Axosine given to three groups of stroke patients (nine patients in each dose group). The highest dose given will be the estimated human equivalent of the effective dose given to rats. All patients will be maintained on their initial dose of Axosine for the full 28 day study period. Axosine will be administered via an implantable subcutaneous pump and ICV catheter system that potentially allows the patient to leave the hospital at the same approximate time that they otherwise would have after such a stroke. In addition to safety monitoring, efficacy monitoring will also be performed, but the small number of patients and the short duration of treatment will probably preclude statistically valid efficacy conclusions to be drawn. Formal efficacy testing will be the purpose of a Phase II study, which will follow the Phase I study if there are no significant safety concerns raised by the Phase I study.

"Filing this IND is an important and exciting milestone for the Company and hopefully for stroke patients as well," stated Dr. Marc Lanser, President of BLSI. "Axosine is truly unique in a number of important ways. Axosine is neither a neuroprotective agent, nor is it a thrombolytic (clot-dissolving) agent (such as TPA) and thus, does not need to be given within hours after symptoms of stroke occur. Axosine does not work by limiting or reversing the brain damage caused by the interruption of arterial blood flow that results in stroke, but instead stimulates brain re-wiring after the stroke is complete. This means, among other things, that the so-called 'treatment window' is markedly extended with Axosine; though for how long we do not yet know. Our studies have shown that rats can begin Axosine treatment up to 24 hours after the completed stroke and still recover motor function. In contrast, thrombolytic and neuroprotective treatments must be given within a few hours of stroke onset (in rats or humans) for there to be any benefit. Clinically, neuroprotective and thrombolytic approaches have failed when given after the stroke is 'complete'; i.e., after there has been significant brain cell death and a functionally important region of the brain has been definitively destroyed by stroke. In contrast, Axosine promotes motor function recovery through the formation of new axonal branches and connections (rewiring) in the brain and spinal cord after the stroke is complete. We believe that Axosine has the potential to change the current clinical treatment paradigm for stroke and other Central Nervous System (CNS) injuries. If we are successful in treating stroke, we will then move on to the treatment of spinal cord injury and traumatic brain injury, two additional indications that could potentially benefit from Axosine treatment," added Dr. Lanser.

---

Boston Life Sciences, Inc. (BLSI) is a development stage biotechnology company engaged in the research and development of novel therapeutic and diagnostic solutions for central nervous system diseases (CNS) and cancer. BLSI's products in development include: ALTROPANE(R) and FLUORATEC(TM) radioimaging agents for the diagnosis of PD and ADHD; AF-1 and Inosine, nerve growth factors for the treatment of acute and chronic CNS disorders; Troponin I, a naturally-occurring anti-angiogenesis factor for the treatment of solid tumors; and novel therapies for the treatment of PD and ADHD.

Statements made in this press release, other than statements of historical fact, represent forward-looking statements. Such statements include, without limitation, statements regarding expectations or beliefs as to future results or events, such as operating results and financial position, the expected timing and results of clinical trials, discussions with regulatory agencies, schedules of IND, NDA and all other regulatory submissions, the timing of product introductions, the possible approval of products, and the market size and possible advantages of the Company's products. All such forward-looking statements involve substantial risks and uncertainties, and actual results may vary materially from these statements. Factors that may affect future results include: the availability and adequacy of financial resources, the level of operating expenses incurred, the ability to obtain intellectual property protection, delays in the regulatory or development processes, results of scientific data from clinical trials, the outcome of discussions with potential partners, regulatory decisions, market acceptance of the Company's products, and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K.

CONTACT: Boston Life Sciences, Inc. Joseph Hernon, 617/425-0200 jhernon@bostonlifesciences.com
SOURCE: Boston Life Sciences, Inc.

http://www.bostonlifesciences.com/news122.htm

DRUGMAKER Elan recently released better-than-expected results for the first quarter after the company narrowed losses and grew sales of its antibiotic Maxipime.

The net loss was down to $33.3m, or 8c a share, from $115.m, or 29c a year earlier while revenue was up 31pc to $134.3m.

Analysts surveyed by Bloomberg had forecast a loss of $93.3m, or 21c, on revenue of $125m.

Elan, which is working with its research partner Biogen Idec to get its multiple sclerosis drug Tysabri back onto the market following its withdrawal last year after fatal side-effects, reported that sales of its Maxipime injectable antibiotic more than doubled to $44.7m after the company solved a supply shortage.

Revenue from the manufacturing business rose to $52.6m from $44.7m.

Having said that, the focus is still on the Tysabri saga. The Federal Drug Administration (FDA) is to decide before June 28 on whether Tysabri can be sold again in the US.

In Europe, Tysabri is likely to be sold in Germany first followed by the Nordic countries, the UK and the rest of the continent.

Most analysts believe that Tysabri will get FDA approval but with a restrictive risk management programme.

According to broker Piper Jaffray, the programme is likely to be both labour intensive and, potentially for those without insurance, cost prohibitive.

And following the expected approval, there will also be a lag period during which the shares are likely to be flat or drift.

Brokers are also advocating a wait and see approach. Shares in Elan are trading at the $14.80 level currently.

According to Goodbody Stockbrokers, on its current projections for Tysabri, based on MS sales only and looking at valuations for potential blockbusters of between 4.5x and 5x peak sales, these multiples would equate to a share price, including the core business, of beteen $15.51 and $16.52.

The broker has just issued an add recommendation on Elan with a price target of $16.50.

AILISH O'HORA
http://www.unison.ie/irish_independent/stories.php3?ca=35&si=1611578&issue_id=14023

Drug Status Not Stopping Education Effort
Houston Chronicle - United States
BOSTON — It was barely two hours after a panel recommended to the Food and Drug Administration that it allow the drug Tysabri back on the market when Dr ...

---

Like Lieberman, Thorp had two treatments with Tysabri before it was pulled. Unlike Lieberman, she is desperate for the drug's return to the market. After the two treatments she said she noticed improvement in her motor skills.

"I was just devastated when they took it off the market," she said. "To me, it was well worth a shot."

# A compound called inosine has had good results in phase I and is currently in phase II.[31] Three differents ways of action have been proposed. First, it produces uric acid after ingestion, which is a natural antioxidant and a peroxinitrite scavenger[32] (peroxynitrite has been correlated with the axons degeneration[33]). Second, in has been shown that induces axonal rewiring and is used as a treatment for stroke,[34] and third, it has shown neuroprotective and anti-inflamatory effects independently of the other two.[35] Currently it is being investigated by Boston Life Sciences under the name axosine
http://en.wikipedia.org/wiki/Multiple_sclerosis

• 09 March 2006
• From New Scientist Print Edition. Subscribe and get 4 free issues.
• Andy Coghlan

THE immune cells that attack the brains and nerves of people with multiple sclerosis could be turned into a weapon against the disease.

This month sees the beginning of a trial of a personalised vaccine for MS, designed to rein in and destroy the renegade white blood cells that attack myelin cells lining the brain and nerves of patients.

To make the vaccine, PharmaFrontiers of Woodlands, Texas, takes blood from an MS patient and extracts a sample of these renegade cells. The cells are then multiplied and weakened with radiation before being re-injected into the patient, whose immune system will then recognise them as damaged and attack them, sometimes wiping them out completely, according to the results of earlier trials. The immune system will also attack healthy renegade cells, which have the same markers on their surface. In one trial of 15 people with MS the rate of new flare-ups was reduced by 92 per cent.

If this success is repeated in the new trial it might mean that regular shots could slow or even arrest progression of the disease. "If that's the case, the earlier we can do it after diagnosis the better," says David McWilliams of PharmaFrontiers. In the current trial, 100 patients will receive the treatment and 50 a dummy treatment. The vaccine would only need to be injected four times a year, while other MS drugs need to be given on a weekly or daily basis.

However, since all previous attempts to develop a vaccine for MS have failed, Richard Rudick of the Mellen Center for Multiple Sclerosis Treatment and Research in Cleveland, Ohio, is cautious about its prospects. "None have worked so far. This one may, but we don't yet know."

In the meantime, good news may await MS patients in the US. This week the US Food and Drug Administration is expected to lift its ban on prescribing Tysabri following new evidence on its safety and effectiveness. Tysabri, which is twice as effective at quelling symptoms as any other MS drug available, was pulled a year ago after three people taking it died from rare brain infections.

The superiority of Tysabri over existing, beta-interferon treatments was shown by three separate studies published in The New England Journal of Medicine last week (vol 354, p 899, p 911 and p 924). "With interferons, we've normally seen roughly a one-third reduction in the relapse rate," says Rudick, who led one of the studies. "With Tysabri, we saw more than a two-thirds reduction."

From issue 2542 of New Scientist magazine, 09 March 2006, page 12
http://www.newscientist.com/channel/health/mg18925423.800.html

tysabri

Elan confident on revenues from Tysabri
RTE.ie - Ireland
Elan has posted a smaller than expected first quarter loss of $0.08 per share, and said it was confident revenues form its Tysabri drug would accelerate a ...

Elan 1Q Loss Narrows, Tysabri To Boost Stock
newratings.com - USA
Elan CEO Kelly Martin says he expects to "build momentum as we move through the year." Goodbody Stockbrokers adds, "Once Tysabri is back on the market ...

Elan reports fall in quarterly loss; Revenues from Tysabri ...
FinFacts Ireland - Ireland
... drugs firm Elan has reported a smaller than expected first quarter loss of $0.08 per share, and said it was confident revenues from its Tysabri drug would ...

Elan reaffirms Tysabri commitment
Irish Examiner - Cork,Ireland
Pharmaceutical company Elan has forecast a €150m-€175m full-year before-tax loss, excluding revenues from its suspended MS drug Tysabri. ...

By Quentin Fottrell
Of DOW JONES NEWSWIRES

DUBLIN (MarketWatch) -- Irish drug maker Elan Corp. PLC (ELN) Thursday reported a significant narrowing of first quarter losses and reiterated that the relaunch of multiple sclerosis drug Tysabri will help the company to return to profitability.

Elan's net loss narrowed to $20.6 million in the quarter ended March 31 from $115.6 million, while basic and diluted losses per share narrowed to $0.05 from $0.29 a year ago. Sales rose 31% to $134.3 million from $102.7 million.

Chief Executive Kelly Martin said the outlook is good. "We expect the breadth and depth of accomplishments that we have achieved in this first quarter to continue and build momentum as we move through the year," he said in a statement. Investor focus remains on Tysabri, which Elan is selling with its U.S. partner Biogen Idec Inc. (BIIB). The companies temporarily suspended sales of the drug last year on safety concerns. "Once Tysabri is back on the market, momentum will return to the stock," said Goodbody Stockbrokers' Ian Hunter, who rates Elan a buy.

At Wednesday's close, Elan was down 15 cents, or 1.3%, at EUR11.40 on the Irish Stock Exchange in a weak overall market. Traders expect the stock to rise on Thursday; the stock is up from about EUR4.73 this time last year.

Chief Financial Officer Shane Cooke said in a statement, "We remain committed to making Tysabri available for patients in the U.S. and Europe and are confident that, with the financial leverage we've created over the year, revenues from Tysabri will accelerate our return to profitability."

The U.S. Food & Drug Administration's final decision on allowing Tysabri back to the market is due by June 28. Analysts expect the drug to return to the U.S. market several weeks after that date. The FDA's advisory committee earlier this year recommended the drug should be approved when used alone, and be preescribed as first-line treatment, meaning before other treatments have failed.

"The company is now facing a crucial few months ahead on all elements of the business," said Davy Stockbrokers' Jack Gorman, who doesn't rate the stock. "The only substantive issue left for the FDA is whether Tysabri should be indicated for use as a first-line or second-line therapy," he added.

The European Commission is also expected to approve Tysabri after its advisory panel last week recommended it for prescription to relapsing patients. In Europe, the process of setting a price and deciding on governmental health systems' co-payments could take several months, meaning it will take longer for the drug to return to the market than in the U.S.

Multiple sclerosis is a debilitating disease that affects about 2 million people worldwide, most of them young adults. Patients experience symptoms ranging from fatigue and blurred vision to poor muscle control with partial or complete paralysis. While the disease worsens over time, affected people usually have periods of relatively good health, alternating with acute attacks of neurological dysfunction.

Goodbody's Hunter forecasts Tysabri reaching sales of $760 million in 2007, with $460 million stemming from the U.S. and $300 million from Europe. He expects the drug to achieve sales of $1.9 billion in its best year.

Elan and Biogen Idec split sales of Tysabri evenly. The companies already once hoped it would become a blockbuster with annual sales of at least $1 billion, but those hopes were - at least temporarily - dashed when safety problems emerged last year in cases when Tysabri drug was used in combination with another product.

Elan's share price collapsed as a result.
Company website: http://www.elan.com
-Contact: 201-938-5400 End of Story
http://www.marketwatch.com/News/Story/Story.aspx?dist=newsfinder&siteid=google&guid={8A8DC04B-9A29-4586-A83A-0FBDD730B218}&keyword=

Health & Medicine Week - May. 11, 2006

The Immune Response Corporation (IMNR) reported in trial results that its T-cell receptor peptide vaccine candidate NeuroVax induces increased FOXP3 expression resulting in re-establishment of normal levels of the FOXP3+ regulatory T-cells believed to be important in controlling development of multiple sclerosis (MS).

Results of the recently completed trial in MS patients were presented by Dennis Bourdette, Oregon Health and Sciences University (OHSU) Department of Neurology chair, during an oral presentation at the 58th Annual Meeting of the American Academy of Neurology in San Diego, California.

This 1-year open-label trial enrolled 25 patients who received monthly injections of NeuroVax. Seventeen of them were newly enrolled patients, and showed statistically lower baseline levels of FOXP3+ mRNA measured by RT-PCR (p=.03) and FOXP3 protein expression by Western blot (p=.02) when compared with healthy controls.

Following immunization of these MS patients with NeuroVax, 14/17 patients at 52 weeks demonstrated increased FOXP3+ mRNA expression over baseline (p=.01) and FOXP3 protein expression as a group was also statistically increased over baseline (p=.02). In a number of patients, FOXP3 message and protein expression became higher than those in healthy controls. These data indicate that a key portion of the strong immune responses induced in patients given NeuroVax include increases in expression of FOXP3, a marker which is associated with the activity of CD4+CD25+ regulatory T-cells. NeuroVax thus may be boosting an important immune regulatory network, which may be clinically beneficial for MS patients.

MS is an autoimmune disease in which the immune system mistakenly attacks normal tissues of the central nervous system. It afflicts approximately 400,000 people in the United States and more than 2.5 million worldwide, according to the National MS Society. The disease is caused by activation of a specific subset of the patient's own white blood cells, pathogenic T-cells, which then attack a fatty tissue called myelin that surrounds and protects nerve fibers and creates scarring (sclerosis) that interferes with the normal transmission of nerve impulses. This damage, in turn, leads to a variety of chronic and highly individual and unpredictable neurological symptoms, ranging from movement and balance problems to vision impairment.

The Immune Response Corporation (IMNR) is an immuno-pharmaceutical company developing products to treat autoimmune and infectious diseases.

http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle&amp;amp;amp;contentvalue=889934&channelID=29#

Boost for Elan as Tysabri set for green light
Athlon Advertiser - Athlone,Co. Westmeath,Ireland
The chances of Elan’s controversial Multiple Sclerosis drug Tysabri returning to international markets received a major boost this week when a key European ...

Elan CFO sees Tysabri rollout in EU, US beginning in 3Q

Last Update: 10:36 AM ET May 4, 2006

DUBLIN (MarketWatch) -- Elan Corp. PLC (ELN) Chief Financial Officer Shane Cooke confirmed Thursday that the marketing of its multiple sclerosis Tysabri in the E.U. and U.S. will begin in the third quarter of 2006, following the likely approval by both continents' drug regulation agencies.

The European Medicines Agency's advisory committee has recommended Tysabri only be used in the E.U. as a treatment for relapsing multiple sclerosis patients; the agency's decision is due sometime this summer.

And the U.S. Food & Drug Administration's advisory committee has advised that Tysabri be reintroduced as a monotherapy in the U.S., a first-line treatment for all MS sufferers; the FDA's decision is due by June 28.

Cooke said on a media conference call that Tysabri's E.U. rollout is expected to begin in Germany "some time in the third quarter" and that the U.S. rollout would take place "in a matter of weeks" following an FDA ruling in the company's favor.

"Germany is a pretty significant part of the European market," Cooke added. "In the next year or so, we'd expect to launch in most other (E.U.) countries."

Cooke went on: "It (Tysabri) will have lower penetration in the E.U. than the U.S., as Europeans don't see the existing therapies as being as effective in relation to their cost."

He said the E.U. has around 150,000 MS patients on a therapy, with an extra 50,000 patients who've quit existing therapies; the U.S. has 200,000 MS patients on a therapy, also with another 50,000 so-called "quitters."

However, he conceded that the process of labeling Tysabri in individual E.U. countries will take several months, compared to the near-simultaneous rollout that will be possible across the U.S.

Lars Ekman, Elan's president of research and development, said he believes the FDA will take on board the FDA advisory committee's majority ruling and approve Tysabri as a first-line therapy.

Elan and partner Biogen Idec Inc. (BIIB) suspended their would-be blockbuster drug in the U.S. on Feb. 28 last year after three patients on combination therapy - including Tysabri - contracted a rare neurological disease called PML.

At 1245 GMT Thursday, Elan was up 8 cents at EUR11.48 on the Irish Stock Exchange in a flat overall market.

Company Web site: http://www.elan.com

http://www.marketwatch.com/News/Story/Story.aspx?dist=newsfinder&siteid=google&guid=%7BF877D141-B703-464B-BB47-C99C98C51AA8%7D&keyword=

Multiple Sclerosis in the News
http://www.mssociety.ca/en/inthenews.htm

---

MS Research: What does the “cure” mean to you?

http://www.mssociety.ca/en/research/default.htm

---

ichannel: Intelligent Television


http://www.ichannel.ca/V30_ms.php

Multiple Sclerosis Research
About - News & Issues - New York,NY,USA
... December 2001 - Minocycline, an antibiotic, was used to treat rats with an experimental disorder that is similar to multiple sclerosis. ...

Epstein-Barr Virus Might Kick-Start Multiple Sclerosis
Newswise Tue, 02 May 2006 6:22 AM PDT
People with multiple sclerosis carry immune cells that over-react to Epstein-Barr virus. EBV has long been suspected of playing a role in MS, but the mechanism linking it to the disease was poorly understood. The new findings show the culprit may be a population of T cells that helps boost other components of the immune system in response to EBV.

Norton woman hailed for work with Multiple Sclerosis Society Akron Beacon Journal Tue, 02 May 2006 0:39 AM PDT In many ways, people with multiple sclerosis live with uncertainty. They never know when the chronic disease of the central nervous system might flare up and cause a host of problems, ranging from minor numbness and tingling to paralysis.

Epstein-Barr Virus Might Kick-Start Multiple Sclerosis Howard Hughes Medical Institute Mon, 01 May 2006 2:08 PM PDT Researchers have found that patients with multiple sclerosis (MS) carry a population of immune cells that overreact to Epstein-Barr virus.

AAN: Benefits of early MS treatment 'remarkable' Medical Post Online Mon, 01 May 2006 6:16 PM PDT SAN DIEGO | Very early treatment of multiple sclerosis significantly delays the initial progression of the disease, a Canadian-led study presented at the meeting here indicates.

Health Business UPI Tue, 02 May 2006 9:25 AM PDT WASHINGTON, May 2 (UPI) -- Researchers said Monday that some cases of MS may be caused by a strong reaction to the Epstein-Barr virus.

Boxer weighs in to help Ian's MS funds fight The Scotsman Tue, 02 May 2006 4:14 AM PDT TOP boxer Kenny Anderson handed over a signed pair of gloves and Scotland vest ahead of a sold-out charity auction in the Capital next month.

Tech Gear Aids Stroke Victims Red Herring Tue, 02 May 2006 6:14 AM PDT Hanger Orthopedic launches a device to help stroke survivors walk normally again.

Spring babies in suicide link The Scotsman Mon, 01 May 2006 5:57 PM PDT PEOPLE born in spring or early summer are almost 20 per cent more likely to commit suicide than those born at other times of the year, research suggests.

Researchers Discover New Biotechnology For Crafting Pharmaceuticals To Outsmart Disease Science Daily Mon, 01 May 2006 9:02 PM PDT Researchers at UC Santa Barbara have developed a new biotechnology that enables scientists to identify and engineer protease substrates, giving them the means of crafting pharmaceuticals to outsmart disease. Their work, authored by Patrick Daugherty, an assistant professor of Chemical Engineering, and Kevin Boulware, a PhD candidate, are published online today in the Proceedings of the National

European Medicines Agency: CHMP, Initial Marketing Authorisation Applications, 24-27 April 2006 Medical News Today Tue, 02 May 2006 0:05 AM PDT The Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions on initial marketing authorisation applications for:-- Acomplia and Zimulti (rimonabant) from Sanofi-Aventis, for use as adjunct to diet and exercise for the treatment of obese patients or overweight patients with associated risk factors, such as type 2 diabetes or dyslipidaemia... click link for more info.

FDA's Likely Approval to Relaunch Tysabri, Despite Rare Fatal Side ...
PharmaLive.com (press release) - Newtown,PA,USA
... and advisory firms focusing on pharmaceutical and health care issues, finds that the likely reintroduction of Biogen Idec/Elan's Tysabri (natalizumab) in the ...

Biogen and Elan's Tysabri gets positive EU opinion
Pharmaceutical Business Review - USA
... Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization for Biogen Idec and Elan Corporation's Tysabri in relapsing ...

EU Panel Recommends Marketing Authorization For Multiple-sclerosis ...
Trading Markets - Los Angeles,CA,USA
... or CHMP, the scientific committee of the European Medicines Agency, issued a positive opinion recommending marketing authorization for Tysabri, a treatment for ...

MS drug Tysabri closer to EU launch
United Press International - USA
CAMBRIDGE, Mass., April 28 (UPI) -- Biogen Idec and Elan said their multiple-sclerosis drug Tysabri has been recommended for approval in Europe. ...

Elan Corp. Is Trading Higher On Tysabri News
Trading Markets - Los Angeles,CA,USA
... Friday morning that the Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization for TYSABRI as a ...

CHMP Issues Positive Opinion for Tysabri (Natalizumab) as a ...
DG News - USA
... the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion recommending marketing authorization for Tysabri® (natalizumab) as ...

Elan's Tysabri drug recommended by EU committee
MarketWatch - USA
... news that the scientific committee of the European Medicines Agency had recommended the return to market of its key drug, multiple sclerosis treatment Tysabri. ...

European Medicines Agency unit approves return of Elan's Tysabri ...
FinFacts Ireland - Ireland
... The Committee recommended that Tysabri be used as single disease modifying therapy either in patients with highly active relapsing-remitting MS who have failed ...