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BIOGEN IMMUNERON GAMMA INTERFERON PHASE II TRIAL

Executive Summary

BIOGEN IMMUNERON GAMMA INTERFERON PHASE II TRIAL in rheumatoid arthritis showed improvement of symptoms in 23 of 30 patients, according to data presented at a June 9 meeting of the American Rheumatism Assn. in Boston. The study was conducted by Frederick Wolfe, MD, at the Arthritis Center in Wichita, Kansas. The trial randomized 33 rheumatoid arthritis patients to receive either 10 or 100 mcg of Immuneron by subcutaneous injection for five days each week during a blinded, four-week trial. For the 30 patients completing the study, improvement over baseline was noted in the number of tender joints, swollen joints, self-assessed pain severity as well as investigator assessment of pain severity, Wolfe, et al, reported. No differences were noted in morning stiffness, grip strength or sedimentation rate, and there were no significant differences in patients receiving 10 mcg and those receiving 100 mcg. "Gamma [interferon] may be an effective therapeutic agent," the study concluded. "Our data suggest that subcutaneous administration of gamma is practical and well tolerated in RA." The investigators noted, however, that side effects were common -- headache occurred in 27% of the patients, fever in 32% and chills in 27%. In a same-day press release, Biogen said that a similar West German trial showed 24 of 40 patients receiving the drug had improvements in rheumatoid arthritis symptoms, particularly increased mobility and reduced pain. Biogen and its West German subsidiary, Bioferon, have filed for regulatory approval in West Germany and currently anticipate approval "later this year," the company said. Biogen is also testing Immuneron in the U.S., Europe and Japan for a number of cancers. At a press conference last October, the company announced that it would seek its first U.S. approval for gamma interferon as a treatment for renal cell carcinoma. The product is in Phase III trials for that indication.
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PS010286

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