ion arthritis drug shows mixed trial results

January 29, 2004

Wednesday January 28, 5:43 pm ET

NEW YORK, Jan 28 (Reuters) - ion Pharmaceuticals, Inc. (NasdaqNM:ALXN -

News) on Wednesday said its experimental treatment for rheumatoid arthritis

showed mixed results in a mid-stage trial, matching findings seen in an

earlier patient study.

The Cheshire, Connecticut-based drugmaker said the Phase IIb trial involved

350 patients who were already taking the standard arthritis treatments

methotrexate or leflunomide. Over a six-month period, they were also given

either a placebo or the ion drug, called eculizumab.

ion said preliminary results of the trial showed that patients given its

drug on a monthly basis showed statistically significant benefit, while

those taking it every two weeks failed to benefit. The company said the

trial results confirm positive and negative results seen in an earlier trial

announced in 2001.

The company said its treatment appeared to be safe and well tolerated, with

similar side effects to placebos.

ion Chief Executive Leonard Bell said it will take the company several

months to complete its analysis of the latest trial, at which time it will

decide how to proceed with U.S. regulators.

Bell said at first glance it seemed " counter-intuitive " that the drug was

successful in relieving symptoms for patients getting it only once a month,

but not statistically significant for those getting it twice a month. But he

said the same trend was seen in both Phase II trials.

" We have to finish our analysis so we can understand it, " Bell said, adding

that the earlier study suggested that certain types of patients showed

greater benefit than others regardless of whether they took it once or twice

a month.

He said different studies suggested the medicine was effective in treating a

rare disease called paroxysmal nocturnal hemoglobinuria, which destroys

blood cells.

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