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Biotech / Medical : MEDX ... anybody following?
MEDX 31.84+0.8%Nov 10 3:26 PM EST

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To: Icebrg who wrote (646)1/29/2003 7:53:16 AM
From: Icebrg  Read Replies (1) of 2240
 
US FDA APPROVES GENMAB’S IND TO INVESTIGATE HUMAX-IL15 TO TREAT RHEUMATOID ARTHRITIS

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; January 29, 2003 – Genmab A/S (CSE: GEN) 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.
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