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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (10765)	7/13/1999 9:36:00 AM
From: RCMac	Read Replies (1) \| Respond to of 17367

TDude, Here is the AMGN release: biz.yahoo.com The aimed-at indication is rheumatoid arthritis: >>. . . based on the strength of the results of two large phase 2 randomized and controlled studies in rheumatoid arthritis and discussions with the Food and Drug Administration, the Company plans to file a BLA with the agency by the end of the year for approval of IL-1ra. An additional phase 3 efficacy trial will not be needed for filing. >>The second of these two studies, in which IL-1ra was combined with methotrexate, produced a statistically significant dose response relationship and demonstrated an added benefit over the use of methotrexate alone. The potential of IL-1ra to reduce both inflammation and bone and cartilage destruction suggests that this molecule may provide a meaningful benefit to patients suffering from rheumatoid arthritis. Additional studies are planned to supplement the safety database, support the regulatory submission and explore in more detail the effect of IL-1ra on disease progression.<< But off-label use for sepsis is apparently a lively possibility. Note this commentary on the AMGN announcement by Rick Harmon: >>Amgen has revived the old Synergen project and plans to file for RA. The combination of TNF antagonism (Celltech, Chiron, Bayer, and the major players, IMNX and CNTO) and IL-1ra could then be used off-label for sepsis. If BPI21 gets the nod, then there is the possibility that an effective cocktail, albeit a disgustingly expensive one, will be available for Gram-negatives. Throw in some work from Merck and a complement inhibitor or two, and you too, for only $40K, can have a cure for acute inflammation......<< Message 10476700 --RCM