] High Dose Cyclophosphamide Achieves Rapid Clinical Improvements in Early, Aggressive Multiple Sclerosis

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High Dose Cyclophosphamide Achieves Rapid Clinical Improvements in Early,

Aggressive Multiple Sclerosis

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High Dose Cyclophosphamide Achieves Rapid Clinical Improvements in

Early, Aggressive Multiple Sclerosis: Presented at AAN

By Sowerbutt SAN DIEGO, C.A. -- April 6, 2006 -- Preliminary

data from a study utilizing 50 mg/kg/day of cyclophosphamide (HiCy)

for 4 consecutive days suggest it is safe and provides rapid clinical

and radiological improvements in patients with early, aggressive

multiple sclerosis (MS). Calabresi, MD, Department of

Neurology, s Hopkins University Hospital, Baltimore, land,

presented the data here at the 58[th annual meeting of the American

Academy of Neurology (AAN).

" This is a study using extremely high doses of cyclophosphamide, a

drug that's been tested for many years, and used mostly in monthly

pulse protocols, " Dr. Calabresi said during his poster presentation

on April 4th. " The concept came from our cancer center group, who has

treated approximately 3000 patients with malignancies and about 200

patients with autoimmune diseases, but not MS. "

Patients who were entered into the open-label protocol had at least

two gadolinium enhancing lesions present on magnetic resonance

imaging, and one clinical exacerbation within the past year. They

were on conventional MS therapy, yet had sustained increases of >1.0

on the Expanded Disability Status Scale (EDSS).

The protocol requires a 4-day hospitalization period, after which

participants became outpatients.

" We've had no deaths on this protocol, " Dr. Calabresi said.

" Clinically, the results recapitulate what has been seen in other,

aggressive bone marrow protocols, where patients with early, very

active disease do very well. Their EDSS goes down, they stabilize for

long periods of time, " he explained.

An advantage of the HiCy protocol, however, is that it does not

require bone marrow stem cell transplantation. " We have found that

the morbidity and mortality is much lower or non-existent with this

protocol, so it's extremely well tolerated and much cheaper because

you don't have to harvest stem cells and give them back to the

patient, " he said.

The results show reductions in lesions from baseline in all 8

patients. Additionally, 5 of the participants experienced sustained

decreases in their EDSS following HiCy therapy, while 3 patients had

similar or increased EDSS.

" The patients who went into this study with high EDSS do not do well;

they likely already had fixed damage " Dr. Calabresi said.

" There were two patients that started out at 6.25 [EDSS] that

continued to slowly progress, which tells us that if the disease is

relatively advanced then this treatment is not worth the risk. If,

however, it's relatively early stage disease, and worsening quickly,

then this may be a therapeutic strategy, " he said.

Adverse events (AEs) and side effects related to treatment reported

during the protocol include nausea, alopecia, anemia,

thrombocytopenia, leucopenia, loss of immunization, febrile

neutropenia, and amenorrhea. No serious AEs have been reported to

date; however, one patient has been hospitalized due to a suspected

exacerbation.

With respect to future plans for the protocol, Dr. Calabresi said,

" We're now following the participants for 1 year, and we want to see

what happens at 2 years. "

[Presentation title: High-Dose Cyclophosphamide in the Treatment of

Aggressive Multiple Sclerosis. Poster PO1.072]

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