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Patients with moderate to severe MS show improvement after high-dose chemotherapy regimen at Stony Brook


STONY BROOK, N.Y., August 14, 2006 Ė 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 Douglas 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 patientís muscular and neurological functions, which can sometimes lead to a debilitating state. In theory, by HDC eradicating abnormal lymphocytes, the personís 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, Crohnís 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 Kenneth W. Zamkoff, M.D.; Lauren Krupp, M.D.; Robert Peyster, M.D.; Patrick Sibony, M.D.; Christopher Christodoulou, Ph.D.; Emily Locher, R.N., and Patricia Coyle, M.D.

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