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Large Phase II Study Of Monoclonal Antibody Initiated in U.S.(MedImmune Inc. starts psoriasis treatment research)
2001 OCT 10 - (NewsRx.com & NewsRx.net) --
MedImmune, Inc. announced September 17, 2001, that it has begun treating psoriasis patients with siplizumab (MEDI-507) in a large Phase II clinical trial.
This trial, which is to enroll approximately 400 patients at 50 sites in the United States and Canada, is a part of MedImmune's planned, comprehensive development program for siplizumab. By the end of 2001, MedImmune expects to have enrolled approximately 750 patients in seven clinical studies with siplizumab.
"We are pleased to initiate this study as a part of our broad development program for siplizumab," said Dr. Christine Dingivan, MedImmune. "From the clinical trials currently underway, we are collecting data related to the drug's safety, efficacy, dosing, and durability of response. Should these trials continue to produce positive results, we expect to initiate our Phase III program in the early part of 2002."
The new Phase II study is a randomized, double-blind, placebo-controlled trial in which approximately 400 patients with plaque psoriasis on at least 10% of their body surface area and a minimum PASI (Psoriasis Area and Severity Index) score of eight will receive subcutaneous injections of siplizumab. The study will compare the potential efficacy of different dosing regimens of MEDI-507, as measured by PASI score, as well as assess the drug's ...
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