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Published on 4/13/2006 in the Prospect News Biotech Daily.

MedImmune begins dosing of lupus patients in phase 1 trial

By Elaine Rigoli

Tampa, Fla., April 13 - MedImmune, Inc. has begun dosing lupus patients in a phase 1 clinical trial to evaluate the safety and tolerability of MEDI-545, its monoclonal antibody targeting interferon-alpha.

The monoclonal antibody is being developed for the potential treatment of patients with systemic lupus erythematosus (SLE or lupus), the company said in a news release.

"Moving forward with our clinical program for MEDI-545 in lupus patients is an exciting next step in our plan to develop new treatments for patients suffering from inflammatory diseases," senior director of clinical development Stanley Pillemer said in the release.

"With this phase 1 program, we look to further increase our knowledge about the role of interferons in lupus disease activity, with the hope of developing a new medical option for patients suffering from this debilitating disease."

MedImmune's lupus interferon skin activity study is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study involving a single intravenous dose of the anti-interferon-alpha antibody in 45 patients who have mild SLE with lupus rash or skin lesions.

MedImmune's development of monoclonal antibodies targeting interferon-alpha stems from a 2004 collaboration agreement with Medarex, Inc. to focus on two specific antibodies, one of which was MDX-1103 (now known as MEDI-545), the release said.

Under the terms of the agreement, MedImmune is responsible for all ongoing clinical development activities.

MedImmune, headquartered in Gaithersburg, Md., is focused on the areas of infectious diseases, cancer and inflammatory diseases.


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