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Scientists Show Monoclonal Antibody Leads to Repair of Myelin Sheath in Laboratory Study of Multiple Sclerosis.


HAWTHORNE, N.Y. -- Researchers at Mayo Clinic have presented details from a preclinical study showing that a recombinant human monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing , administered in a single low dose in a laboratory mouse model of multiple sclerosis, can repair myelin myelin /my·elin/ (mi´e-lin) the lipid-rich substance of the cell membrane of Schwann cells that coils to form the myelin sheath surrounding the axon of myelinated nerve fibers. , the insulating covering over nerve fibers in the central nervous system.

The study was presented on October 9, 2007 at the American Neurological Association The American Neurological Association, is a professional society with a mission of educating neurologists and physicians as well as increasing knowledge and enhancing treatment of diseases of the nervous system.[1] It was founded in June of 1875.  meeting in Washington, D.C.

"We are excited to be collaborating with Mayo on the development of this therapy," noted Andrew R. Blight, Ph.D., Chief Scientific Officer at Acorda. "The options for treatment of MS are still quite limited, and a new approach that could repair damage to the central nervous system would represent an important advance for the individuals who live with this disease."

In multiple sclerosis and some other disorders of the central nervous system, the immune system immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
 attacks and destroys the myelin sheath, causing the nerve to lose its ability to conduct electrical impulses from the brain to the body, resulting in the disabilities associated with those conditions.

The antibody, which was genetically engineered for large-scale production, binds to myelin and the surface of cells in the brain and spinal cord, triggering the cells to begin the repair process called remyelination. The study was conducted using a laboratory mouse model of chronic progressive multiple sclerosis in humans. The antibody was delivered alone and in combination with the steroid methylprednisolone methylprednisolone /meth·yl·pred·nis·o·lone/ (-pred-nis´ah-lon) a synthetic glucocorticoid derived from progesterone, used in replacement therapy for adrenocortical insufficiency and as an antiinflammatory and immunosuppressant; also ; remyelination was detected in both instances.

The antibody is being developed by Mayo Clinic and Acorda Therapeutics. Under a license agreement between Acorda and Mayo Clinic, Acorda holds exclusive worldwide rights to certain patents and other intellectual property for this antibody related to use and treatment of central nervous system disorders Nervous system disorders

A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency
, including multiple sclerosis. Both Acorda and Mayo will be working on the steps leading to a future Investigational New Drug Application (IND) and a Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. .

About Multiple Sclerosis

Multiple sclerosis is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. According to the National Multiple Sclerosis Society The National Multiple Sclerosis Society, a United States-based non-profit organization, and its network of chapters nationwide promote research, educate, advocate on issues relating to multiple sclerosis, and organize a wide range of programs, including support for the newly , approximately 400,000 Americans have MS, and every week about 200 people are newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.

The NMSS NMSS National Multiple Sclerosis Society
NMSS Nuclear Material Safety and Safeguards
NMSS New Model Special Schools
NMSS Network Management Support Services
 estimates the direct costs of medical care for MS patients in the United States to exceed $6 billion annually. Additionally, a recent NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury Spinal Cord Injury Definition

Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control.
Description

Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States.
, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules[TM] (tizanidine hydrochloride), a short-acting drug for the management of spasticity spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2).

spas·tic·i·ty
n.
1. A spastic state or condition.

2. Spastic paralysis.
. Acorda's lead clinical product, Fampridine-SR, is in a Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study.  to evaluate its safety and efficacy in improving walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval of Fampridine-SR, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
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Date:Oct 16, 2007
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