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Tuesday, April 23, 2013

Mayo Clinic and Acorda Therapeutics Announce Initiation of Phase 1 Trial of Remyelinating Antibody in People with Multiple Sclerosis

Discovered at Mayo Clinic, rHIgM22 Represents Potential New Approach to MS Treatment

Apr. 23, 2013-- Mayo Clinic and Acorda Therapeutics, Inc.  today announced that the first patient has been enrolled in the first clinical trial of rHIgM22, a remyelinating antibody being studied for the treatment of multiple sclerosis (MS). This is a Phase 1 clinical trial enrolling people with MS to assess the safety and tolerability of rHIgM22. The study also includes several exploratory efficacy measures.

In MS, a person’s own immune system destroys myelin, a substance that insulates nerves and facilitates conduction of nerve impulses that control neurological function such as movement and vision. Progressive damage to myelin causes functional impairment in people with MS. Currently there are no approved therapies that stimulate the repair or regrowth of myelin once it has been damaged.

“This remyelinating antibody, if successful in clinical trials and approved, would be a novel approach to treating people with chronic neurologic deficits from multiple sclerosis or other similar conditions,” said Moses Rodriguez, M.D., a neurologist specializing in MS at the Mayo Clinic, whose team initially identified rHIgM22. “We are excited that this Mayo discovery is now being evaluated in people with MS to determine its therapeutic potential.”

“The current standard of MS care does not address the underlying issue of the loss of myelin that leads to progressive functional impairment in people with MS,” said Anthony Caggiano, M.D., Ph.D., Acorda’s Vice President of Research and Development. “Stimulation of remyelination represents a novel and potentially significant advance in the treatment of people with MS, and one which could be complementary to existing therapies. In preclinical studies, rHIgM22 has shown the ability to stimulate production of new myelin and improve function.”

The primary objective of this double-blind, randomized single ascending dose study is to evaluate the safety and tolerability of rHIgM22 in people with MS. The study also includes several exploratory efficacy measures, including magnetic resonance imaging and standard clinical measures used to assess people with MS, such as walking ability. Participants in the trial will receive either placebo or rHIgM22 administered as a single intravenous dose. If rHIgM22 is well tolerated in study groups receiving a low dose of rHIgM22, subsequent groups will receive single infusions of higher doses. Participants in this study will continue receiving their standard MS treatments.

Additional details on this clinical study, including enrollment criteria and contact information for study sites, can be found at:

The remyelinating antibody program is the result of a research collaboration between Acorda and the Mayo Foundation for Medical Education and Research. Acorda licensed worldwide rights to patents and other intellectual property for these antibodies related to nervous system disorders under an exclusive license agreement with the Mayo Clinic in September 2000. Dr. Rodriguez is an employee of Mayo Foundation.

About MS and rHIgM22

Multiple sclerosis (MS) is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord by destroying myelin (a process known as demyelination) and eventually the nerve fibers themselves. Myelin is a fatty layer of membranes that insulates nerves, facilitating the transmission of electrical impulses through nerve pathways that control neurological functions such as movement, bowel/bladder function, vision and sexual function.

The cells that make myelin, called oligodendrocytes, can initially repair myelin, but as MS progresses, there is little spontaneous repair. Currently, there are no therapies that repair or restore myelin in demyelinating diseases such as MS. If myelin is able to be repaired it could restore electrical conduction and may serve to protect the exposed nerve fiber from further damage.

Preclinical studies in animal models and laboratory studies have demonstrated rHIgM22 can protect oligodendrocytes (the myelin producing cells) and stimulate them to repair areas of demyelination. rHIgM22 treatment of these animals also resulted in sustained improvements in motor activity.

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