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Biotech / Medical : AutoImmune-AIMM
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To: kathleen who wrote (55)4/9/1997 2:37:00 PM
From: Dr. John M. de Castro   of 298
 
Well one potential Myloral competitor bites the dust. The majority of new drugs wash out of clinical trials, not because of efficacy problems, but due to toxicity issues. The fact that Myloral has not is a major positive.

John de C

Pharmacia & Upjohn Inc. Discontinue Linomide Multiple Sclerosis Clinical Trials

LONDON, April 9 /PRNewswire/ -- Pharmacia & Upjohn Inc. reported today that it will discontinue clinical studies with Linomide Tablets (roquinimex) for treatment of multiple sclerosis (MS) due to an unexpected incidence of cardiovascular events. The company has determined that the occurrence of these events produces an unacceptable benefit-risk profile for Linomide in this particular indication.
Eight cases of myocardial infarction were reported in two Phase
III clinical studies evaluating the safety and efficacy of Linomide in the treatment of MS. A third trial had no reports of myocardial infarctions.
The two studies in which those reports were involved began enrolling patients in April 1996 and included about 1,200 patients with relapsing- remitting and secondary progressive forms of MS. The studies were coducted in North America, Europe and Australia. The design of both studies was double-blind, placebo controlled.
Treatment with Linomide will be stopped for patients in all three studies. Patients will be medically evaluated according to termination visit procedures in the study protocols.
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