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Drug combination fuels hope for MS fight

By MARIA CHENG, AP Medical WriterFri Jul 21, 4:54 PM

ET

Four years ago, 28-year-old multiple sclerosis patient

Ayres was wheelchair-bound and paralyzed. " I was

trapped in a body that wouldn't do anything, " she

says. Now, following an experimental drug treatment,

she has regained mobility and is studying for a

doctoral degree.

Ayres was one of 27 patients with aggressive MS who

was treated in an open trial with a course of

cancer-drug mitoxantrone and copaxone, which is used

to treat relapsing MS.

Like Ayres, many of the other patients in the study

experienced results so remarkable that some MS

experts, while expressing caution, are now taking a

second look at the preliminary experiment.

A three-year controlled study is being launched at 10

centers across the United Kingdom to further

investigate the potential of the drug combination. The

results of the initial trial, led by Dr Mike Boggild

at the Walton Centre in Liverpool, will be published

next month in the Journal of Neurology.

Mitoxantrone is an anti-cancer drug so powerful that

it is potentially toxic and can only be used safely in

the short term. So, Boggild and his colleagues

combined its use with copaxone — a notoriously

slow-acting drug.

" We decided to overlap the treatments because we

wanted to give some time to copaxone to build up its

effect, " says Boggild.

What happened next was dramatic. " Patients who were

just the worst of the worst did remarkably well, "

Boggild said.

" We think we've tapped into an unexpected synergy

between the two drugs that gives you more than the sum

of the parts, " he says. With a few exceptions, Boggild

says most of the patients treated with the drug

combination are now essentially " trouble-free. "

Though one patient developed acute leukemia — a known

side effect to mitoxantrone treatment — Boggild says

the majority of patients haven't had disease relapses.

Patients were first given a limited course of

mitoxantrone, before being started on copaxone,

usually a few months later. In Ayres' case, recovery

was rapid. " From barely being able to wave my hand to

walking out of the rehabilitation center took a few

weeks, " she says.

While the study has clearly generated some impressive

results, many experts say more time is needed.

" It's a small study with no control group, " says Dr

Robyn Wolintz, co-director of the MS Center at

Maimonedes Medical Center in New York. " They also gave

different people different doses of mitoxantrone, and

that's not standard, " says Wolintz, explaining that

changing the dosages and the frequency of the

treatment makes it difficult to reproduce these

results to verify the drugs' efficacy.

" We're talking about an early, small study, " says

on, of the MS Society in the United

Kingdom. Though on characterized the results as

" encouraging, " he believes it is necessary to conduct

a large-scale comparative investigation to establish

how the mitoxantrone-copaxone combination ranks

against other known and potential drug cocktails.

Still, some experts believe Boggild and his colleagues

have stumbled upon a valid hypothesis. " Single drugs

are not what gets the job done, " says Dr Richert,

vice-president of research department in the United

States' National MS Society. " It really is likely that

more and more combination therapies will be used. "

For patients with particularly aggressive MS, the

proposed treatment may provide some hope. " The people

who could benefit from this have nothing else at their

disposal, " says Wolintz.

And unfortunately, medicine is far from an exact

science. " Many physicians make their decisions based

on incomplete data, " says Richert. " Even though

there's not sufficient data to make any kind of formal

recommendation, there is enough data to say that it is

reasonable to make this option available to physicians

and their patients when they've weighed all the pros

and cons of the situation. "

For patients like Ayres, who still takes daily

injections of copaxone, life without the treatment is

unimaginable. " When I was lying in my hospital bed,

not even able to twitch my toes, I was jealous of

anyone who could walk, " she told The Associated Press.

Despite the potential side effects, which include

leukemia and cardiac problems, Ayres says the

treatment was worth the risk. " I didn't have a lot of

options, " she says, " and to be completely normal now

was worth everything that I went through. "

Copyright © 2006 The Associated Press.

Copyright © 2006

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