The Holy Name Hospital Multiple Sclerosis Comprehensive Center will be the first hospital in the tri-state region to administer a breakthrough infusion therapy for MS patients that was licensed by the FDA earlier this week. The new biologic approach treats patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of symptom flare-ups or exacerbations of the disease. MS is a chronic, often disabling disease of the brain and spinal cord.

Natalizumab also known as Antegren, released as Tysabri on Wednesday, November 24, 2004, is a monoclonal antibody bioengineered from part of a mouse antibody to closely resemble a human antibody. It is being marketed under the trade name Tysabri. The product is given intravenously once a month in a hospital or physician's office.

The Holy Name Hospital Multiple Sclerosis Comprehensive Center, which provides diagnostic, therapeutic, and support services to minimize the disabling effects of MS and to maximize each patient's potential, will administer Tysabri to Joe Giles, director of critical care services at Holy Name Hospital and a Dumont resident who has had MS for three years. "As a registered nurse, I've done a lot of research on all of the trial studies of Tysabri and I am very optimistic and thankful that the opportunity has come along," explained Giles.

Joe Giles is one of approximately 350,000 individuals that have been diagnosed with MS in the U.S., with an estimated 10,000 new cases diagnosed each year according to the Multiple Sclerosis Association of America. The most common form of MS at the time of initial diagnosis is a relapsing-remitting form, in which acute symptoms or worsening of neurological function (referred to as "relapses, attacks or exacerbations,") occur intermittently. The symptoms can diminish or disappear for months or years between relapses. "I'm hopeful that this drug will lessen the occurrence of the exacerbations or the amount of lesions that I have. I have three children, so life has to go on for me."

The Holy Name Hospital Multiple Sclerosis Comprehensive Center in Teaneck, NJ was in the Sentinel study, which combined the use of Avonex and natalizumab. Mike Maron, President and CEO stated, "We are so very proud of our MS Center for being a leader in the country in providing premiere MS drug therapies."

Although the cause of MS is unknown, it is widely considered to be an autoimmune disease in which a person's immune system attacks the brain and/or spinal cord. Tysabri appears to work by binding to these immune system cells, thus preventing them from traveling to the brain where they can cause damage.

Antibodies are proteins produced by a person's immune system to fight foreign substances, such as infections. Monoclonal antibodies, such as natalizumab, can be produced in large quantities in cell culture in a laboratory setting. They can be designed to bind to proteins on the body's normal cells. By recognizing and attaching to these proteins, monoclonal antibodies can interfere with (or alter) normal or abnormal cellular responses. In this way, monoclonal antibodies may be useful in the treatment of certain diseases such as MS.

"This innovative treatment for multiple sclerosis represents a new approach to treating MS--exciting news for patients with this serious disease," said Dr. Lester M. Crawford, acting FDA commissioner. "While we eagerly await long-term results from ongoing clinical trials, we have reason to believe that Tysabri will significantly reduce relapses in MS."

The approval of Tysabri is based on positive results seen in patients after one year of treatment. This product received accelerated approval because it appears to provide substantial benefit for patients with a serious disease. As part of that approval, the manufacturer has committed to continuing its trials of this product for another year.

Tysabri was evaluated for safety and efficacy in two ongoing randomized, double-blind, placebo-controlled trials in patients with relapsing forms of MS. In the first clinical trial of the product's safety and efficacy, the drug reduced the frequency of relapses by 66 percent relative to placebo.

In a second trial, patients who had been treated with Avonex (interferon beta-1a), an approved treatment for MS, but who had experienced one or more relapses while on Avonex, were randomized to receive Tysabri or placebo. Avonex was continued throughout the study for both groups. In this trial, natalizumab reduced the frequency of relapses by 54 percent relative to placebo.

The most frequently reported serious adverse reactions were infections, including pneumonia, temporary hypersensitivity reactions (such as rash, fever, low blood pressure, and chest pain), depression, and gallstones. These serious adverse reactions were uncommon. Common adverse reactions were generally mild and included non-serious infections (such as urinary tract, lower respiratory tract, GI system, and vaginal infections), headache, depression, joint pains, and menstrual disorders.

Tysabri is marketed by Biogen Idec, Inc., of Cambridge, Massachusetts, and Elan Pharmaceuticals, Inc., of Dublin, Ireland. Biogen-Idec/Elan's Antegren (natalizumab) is a novel, first-in-class drug for the treatment of multiple sclerosis (MS).

The Holy Name Hospital Multiple Sclerosis Comprehensive Center, the Department of Neurosciences at the University of Medicine and Dentistry of New Jersey-New Jersey Medical School (NJMS) and UMDNJ-University Hospital in Newark have established the Multiple Sclerosis Network of New Jersey. The network, a comprehensive, coordinated MS program, is the first in the state to centralize research, education, and treatment protocols for MS. The network is under the medial direction of Professor of Neurosciences Stuart D. Cook, M.D., president of UMDNJ. June Halper, M.S.N., R.N.C.S., A.N.P., executive director and chief executive officer of the MS Center, is also the network's executive director. Patients at the MS Center now have access to UMDNJ's research studies and clinical trials. A shared database coordinates care, enabling patients to move effortlessly between services offered by Holy Name and UMDNJ. Through the years, the MS Center has achieved many major accomplishments, including the use of the baclofen pump for spasticity in patients with MS, research in bladder management, treatment of acute exacerbations, and a study to treat male impotence using Viagra. The center is currently involved in Betaseron phase IV data collection and was selected as one of 31 North American sites for the secondary-progressive Betaseron study. The Holy Name Hospital MS Center is the administrative seat of the Consortium of Multiple Sclerosis Centers, the world's largest professional organization of MS care providers. The consortium is a source of education, training, and networking for MS health professionals.

MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

For more information on the Holy Name Hospital Multiple Sclerosis Comprehensive Center, please contact us via email MS@holyname.org or telephone (201) 837-0727.

Holy Name Hospital is a fully accredited, not-for-profit community hospital located in suburban Teaneck, New Jersey. Founded and sponsored by the Sisters of St. Joseph of Peace in 1925, the hospital has grown to become a comprehensive 361-bed medical center offering the most modern medical technology coupled with an enduring tradition of compassion and respect. Affiliation with New York Presbyterian Health System further brings the advantages of large urban hospitals to our community, with access to clinical trials and expanded education for our physicians.