Synergen Inc. said it has begun enrolling patients for a Phase II clinicaltrial of its drug, Antril, in the treatment of rheumatoid arthritis.The trial will involve a total of 500 patients at more than 30 Europeancenters. The patients will receive one of three daily doses of Antril or aplacebo for six months.Boulder, Colo.-based Synergen's Susan Eustis said the dosages will besimilar to those administered in the company's first Phase II trial lastyear involving 175 patients.In that study, nine patient groups received subcutaneous injections of20, 70 or 200 milligrams at intervals of one, three or seven times aweek. The results, according to Synergen, showed that Antril reducedthe number of swollen joints and that daily injections had the mostsignificant effect.Synergen said the second phase two trial will attempt to better definethe effects of the drug and the most appropriate daily dosage.INDEC Pharmaceuticals Corp., of San Diego, also is involved inresearch for treatment of rheumatoid arthritis. INDEC is testing aprimatized antibody, called IDEC-CE9.1. The company Friday releasedPhase I trial results showing that 13 of 25 patients, taking escalatingdoses, experienced a reduction of rheumatoid arthritis symptoms. Thetests also revealed no infusion-related adverse reactions and there wasno quantifiable evidence of immune system rejection of the antibody.David Ludvigson, IDEC's senior vice president and chief financialofficer, said the patients each received a single dose at levels rangingfrom .03 milligrams per kilogram of body weight to 4.0 milligrams perkilogram of body weight. The antibody was jointly developed by IDECand SmithKline Beecham.IDEC has begun enrolling patients for a Phase I/II trial involvingmultiple doses of IDEC-CE9.1 and different dosing schedules. Clinicalend points include safety and tolerance, rate of antibody clearance fromthe blood, patients' immune response and clinical activity. n
-- Charles Craig
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