WHAT IS MULTIPLE SCLEROSIS

MS is thought to be an autoimmune disease that affects the central nervous system (CNS). The CNS consists of the brain, spinal cord, and the optic nerves. Surrounding and protecting the nerve fibers of the CNS is a fatty tissue called myelin, which helps nerve fibers conduct electrical impulses.

In MS, myelin is lost in multiple areas, leaving scar tissue called sclerosis. These damaged areas are also known as plaques or lesions. Sometimes the nerve fiber itself is damaged or broken.

Myelin not only protects nerve fibers, but makes their job possible. When myelin or the nerve fiber is destroyed or damaged, the ability of the nerves to conduct electrical impulses to and from the brain is disrupted, and this produces the various symptoms of MS.

• · Relapsing-Remitting
  Characteristics: People with this type of MS experience clearly defined flare-ups (also called relapses, attacks, or exacerbations). These are episodes of acute worsening of neurologic function. They are followed by partial or complete recovery periods (remissions) free of disease progression.
  Frequency: Most common form of MS at time of initial diagnosis. Approximately 85%.
• · Primary-Progressive
  Characteristics: People with this type of MS experience a slow but nearly continuous worsening of their disease from the onset, with no distinct relapses or remissions. However, there are variations in rates of progression over time, occasional plateaus, and temporary minor improvements.
  Frequency: Relatively rare. Approximately 10%.
• · Secondary-Progressive
  Characteristics: People with this type of MS experience an initial period of relapsing-remitting disease, followed by a steadily worsening disease course with or without occasional flare-ups, minor recoveries (remissions), or plateaus.
  Frequency: 50% of people with relapsing-remitting MS developed this form of the disease within 10 years of their initial diagnosis, before introduction of the “disease-modifying” drugs. Long-term data are not yet available to demonstrate if this is significantly delayed by treatment.
• · Progressive-Relapsing
  Characteristics: People with this type of MS experience a steadily worsening disease from the onset but also have clear acute relapses (attacks or exacerbations), with or without recovery. In contrast to relapsing-remitting MS, the periods between relapses are characterized by continuing disease progression.
  Frequency: Relatively rare. Approximately 5%.

NERVOUS SYSTEM REPAIR AND PROTECTION INITIATIVE ROLLING BACK THE RAVAGES OF MS
Nat. MS Soc. 2005

What if we could actually reverse the damage that MS causes, restoring function to those who have been living with the disease for years? Recent scientific advances in many different fields are now, for the first time, coming together to bring the dream of protecting and repairing brain tissue and restoring function within our grasp. The Society now targets this vital quest with a program that could dramatically impact future disease management, improve the lives of the estimated two million people worldwide living with MS, and could ultimately lead to a cure.

A specially convened National MS Society Task Force determined that the best way to accelerate nerve tissue repair is to bring together the appropriate clinical specialists and basic laboratory scientists to form partnerships to conduct all elements of the study, from basic research to human clinical trials.

Collaborating to make tissue repair and protection a reality.
To ensure the speediest results, the task force recommended that the Society fund as many centers as can meet the extensive expectations of the project. This invites a range of creative approaches and ensures that trials can be replicated and verified in multiple locations. A worldwide “request for proposals” for this topic has been circulated, and many institutions around the world have indicated their interest. We will know in June 2005, after a thorough peer-review process, which and how many partnerships will be launched.

The task force established these aggressive goals for collaborative groups seeking our funding:

*Move tissue repair and protection studies out of the test tube and laboratory mice into human model testing.
*Monitor tissue repair and protection in humans in a non-invasive fashion to determine whether the treatment is working.
*Ensure that successful repaired issue is protected from the future ravages of multiple sclerosis.

Challenges and the future.
Leading researchers now believe that treatments aimed at protecting nerves and rebuilding myelin and damaged nerve fibers are on the horizon. This unique effort – unparalleled anywhere in the world – will not come cheaply. We are preparing to give the largest grants (up to $5.5 million/award) ever offered by any funding agency for nerve repair. This funding level will allow scientists to form new alliances, to re-tool and hone their scientific and clinical skills for this very specific effort, to attract more “heads and hands” to the problem, and to utilize the best available technology and develop needed new technologies to achieve our goals.

Scientists and clinicians have a challenge to make tissue repair and protection a reality. Our challenge is to ensure they get the funding to succeed.


PROMISING MULTIPLE SCLEROSIS TREATMENTS ON THE WAY
Mark Babineck (Source: Reuters Health 2005-04-12 17)

HOUSTON (Reuters) – The suspension of sales of promising multiple sclerosis drug Tysabri earlier this year was devastating to disease sufferers, but it has opened a window of opportunity to alternative treatments.

Among the therapies in the pipeline is Tovaxin, a PharamaFrontiers Corp., product developed at the Baylor College of Medicine in Houston. “Tovaxine is a fascinating concept,” said Dr. Edward Fox, director of the Multiple Sclerosis Clinic of Central Texas in Austin. “It’s basically a way of immunizing yourself against your own bad blood cells. It’s much more a magic bullet.”

Tysabri was considered the leading therapy for MS until February, when maker Biogen Idec suspended sales after a patient died from a rare brain infection. Two other patients have been diagnosed with the infection since then. Biogen told Reuters last week it still hopes to bring back Tysabri for patients who do not have suppressed immune systems.

“It still is a remarkably effective drug and a tolerable drug and it may yet come about as an MS drug,” Fox said. “They may find it safe as a single drug, but not in combination with other medications. It’s still an open story.”

There are other treatments farther on the horizon, Fox said, including monoclonal antibodies aimed at selective portions of the immune system and a pill that could replace shots, intravenous drips and other more invasive techniques.

PharmaFrontiers is hopeful Tovaxin can fill the void sooner. Currently, in U.S. Food and Drug Administration trials, the treatment sparks an autoimmune reaction against the rogue Tcells that are thought to attack the protective sheath around nerve fibers, causing MS.

Tovaxin is not a drug. Rather, it is a treatment that redirects a patient’s own T-cells, meaning it is developed specifically for each case. “It’s always going to be an individualized treatment,” PharamaFrontiers Chief Executive Officer David B. McWilliams said. “It seems like the disease is individualized. One size does not fit all.”

PharmaFrontiers, based near Houston, acquired Tovaxin when it acquired Opexa Pharmaceuticals Inc. last November. If Tovaxin is approved, PharmaFrontiers wants to serve MS patients across the nation and around the world, likely meaning facilities in Europe and Asia. That sort of expansion will require cash and McWilliams leaves open the possibility his company could be acquired by a bigger fish some day.

“These things require continual amounts of funding,” he said. “At some point in time we’ll seek out a European partner and a Far East partner to help pay for parts of this. It clearly will require some more money.

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