*MS Article On Chemo Drug*

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Patients with Moderate to Severe MS Show Improvement After High-Dose

Chemotherapy Regimen at Stony Brook

Medical Center / Health Care Press Release

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Stony Brook University Hospital· Stony Brook, NY 11794-7755

Mon, 14 Aug 2006, 16:00:00

http://commcgi.cc.stonybrook.edu/artman/publish/article_1178.shtml

STONY BROOK, N.Y. -- High-dose chemotherapy has demonstrated significant

potential in fighting the progression of multiple sclerosis (MS), and,

unexpectedly, many patients enjoy marked improvement in their

neurological functions according to a study by researchers at Stony

Brook University. Results are reported in the August 14 online edition

of the American Medical Association's Archives of Neurology and set for

print publication in October.

A group of patients with moderate to severe MS who had stopped

responding to therapy experienced improvements in quality of life and

neurological functioning and showed no signs of advancing disease after

taking high-dose cyclophosphamide (HDC). The intensive four-day regimen

was administered by a team of physicians and specialists at Stony Brook

University Hospital.

" While a majority of MS patients can have their disease controlled with

standard medicines, some suffer from disease progression despite this

intervention, " says E. Gladstone, M.D., Assistant Professor of

Hematology/Oncology in the Department of Medicine and lead investigator

of the study. " It is for this group of patients that the novel therapy

of HDC is promising and should continue to be studied. "

The therapy is based on HDC killing white blood cells called

lymphocytes. In normal individuals, lymphocytes fight infections and

stave off cancer cells. But in patients with autoimmune diseases, such

as MS, these cells target normal tissue for destruction. This disrupts

the patient's muscular and neurological functions, which can sometimes

lead to a debilitating state. In theory, by HDC eradicating abnormal

lymphocytes, the person's autoimmune disease is turned off or even

potentially cured.

According to the report, overall the treatment was found to be safe with

minimal toxicity and morbidity and improved clinical outcomes. All of

the patients had brain magnetic resonance imaging (MRI) and

neuro-ophthalmologic evaluations at six month intervals, along with

quarterly disability and quality-of-life assessments for up to two years

after HDC treatment. No patient had a new lesion on brain MRI or showed

enhanced brain lesions. In addition, patients reported improvement in

all of the quality-of-life parameters measured, such as physical

functioning, body pain, and mental health, and significant neurological

improvements included changes in gait, bladder control and visual

function.

Regarding the Expanded Disability Status Scale (EDSS), a standardized

measure of neurologic disability (1= normal, 10=death) based upon

clinical examination, no patients had an increased EDDS score by more

than one. Five patients had a decreased EDSS score by one or more. The

eight functional neurological systems examined for the EDSS are

pyramidal, cerebellar, brain stem, sensory, bowel and bladder, optic,

cerebral, and other.

Dr. Gladstone has also studied and published reports on the benefits of

HDC for patients with other autoimmune diseases, such as lupus, Crohn's

disease, and myasthemia gravis. At Stony Brook Dr. Gladstone will

continue to evaluate MS patients for this treatment protocol. He says

that further investigation of the HDC regimen for MS patients is

necessary to determine the most appropriate patients for this treatment.

Co-investigators for the study, all from Stony Brook University Medical

Center, include W. Zamkoff, M.D.; Krupp, M.D.;

Peyster, M.D.; Sibony, M.D.; Christodoulou, Ph.D.;

Locher, R.N., and Coyle, M.D.

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© Stony Brook University 2006