Indications -- Psoriasis/Chronic Inflammation Message Board

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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation

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To: keokalani'nui who wrote (332)	1/29/2003 9:23:07 AM
From: scaram(o)uche	Read Replies (1) of 631

US FDA Approves Genmab's IND to Investigate Humax-IL15 to Treat Rheumatoid Arthritis Wednesday January 29, 8:07 am ET Resume: The US Food and Drug Administration (FDA) has approved Genmab's Investigational New Drug (IND) application for a Phase II clinical study using HuMax-IL15 to treat Rheumatoid Arthritis (RA). COPENHAGEN, Denmark, Jan. 29 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN - News) announced today that the US FDA has approved its IND to initiate US sites in an ongoing Phase II study using HuMax-IL15 to treat RA. At the end of 2002 Genmab initiated this Phase II study in Europe using HuMax-IL15 to treat RA. About the study The study will be a multiple dose, double-blind, placebo-controlled trial in patients with active RA who have previously failed one or more disease modifying anti-rheumatic drugs (DMARDs). Patients will receive doses of 40 mg, 80 mg, 160 mg or 280 mg of HuMax-IL15 or placebo once every two weeks for 12 weeks and will be followed for 12 weeks after the final dose. The objective of the study is to demonstrate efficacy as measured by the industry recognized ACR score as well as safety. About Genmab A/S Genmab A/S is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, rheumatoid arthritis and other inflammatory conditions, and intends to assemble a broad portfolio of new therapeutic products arising from research into the human genome. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche and Amgen. A broad alliance provides Genmab with access to Medarex Inc.'s array of proprietary technologies, including the UltiMAb(TM) platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab is headquartered in Denmark and has operations in Utrecht, The Netherlands and Princeton, New Jersey in the US. For more information about Genmab, visit www.genmab.com. (snip)

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