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Biotech / Medical : Biogen -- Ignore unavailable to you. Want to Upgrade?


To: Beltropolis Boy who wrote (1089)7/20/1999 9:16:00 AM
From: Harold Engstrom  Read Replies (1) | Respond to of 1686
 
Chris, clearly Avonex is the revenue-driver now and for the next few quarters. The Lehman estimates look as good as any. Estimates from here on out will be only incrementally off - until Amevive launches. Then the company will be harder to predict because of the more diverse base of sales. When Antova, VLA4, and others launch then the analysts will have to start earning their money!



To: Beltropolis Boy who wrote (1089)7/25/1999 3:45:00 PM
From: JEB  Read Replies (1) | Respond to of 1686
 
Hey, is this us?

clinicalstudies.info.nih.gov@cd40

Protocol Number: 99-AR-0133



Title: An Open-Label, Multiple-Dose Study to Evaluate the Efficacy, Safety and Pharmokinetics of BG9588 (Anti-cd40L Antibody) in Subjects with Proliferative Lupus Glomerulonephritis (SLE-GN)

Number: 99-AR-0133

Summary: Studies in animals and humans with lupus nephritis have demonstrated that essential role of cd40 ligand/cd40 interaction in the production of pathogenic autoantibodies. Anti-cd40L antibody treatment of mice with lupus nephritis ameliorates disease and improves survival. BG9588 is a recombinant humanized monoclonal antibody that specifically binds to cd40 ligand (cd40L) expressed on the surface of activated T lymphocytes and thereby blocks the cd40L/cd40 interaction between T and B cells that is required for the initiation for certain antibody responses. Available preclinical data indicates that BG9588 does not cause a global blockage of the immune response to pathogens and that its effects are reversible upon clearance from the systemic circulation. In this Phase I/II open-label, multiple-dose, multicenter study, 30 subjects with active proliferative lupus nephritis will receive 20 mg/kg BG9588 by IV infusion once every 14 days for three doses, and then once every 28 days for four doses for a total of 7 doses. The primary objective is to determine if BG9588 can decrease proteinuria by greater than or equal to 50 percent from baseline without worsening renal function. The secondary objectives are to determine the safety and pharmacokinetics of BG9588, as well as the effects of BG9588 on renal flares; cellular casts; C(3) levels and anti-cyclone titer; requirement for prednisone; general lupus activity; and quality of life.

Sponsoring Institute:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

...etc.