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Biotech / Medical : Biotransplant(BTRN) -- Ignore unavailable to you. Want to Upgrade?

To: seminole who wrote (1171)	12/27/2001 2:27:55 PM
From: tnsaf	Read Replies (1) \| Respond to of 1475

Thursday December 27, 2:00 pm Eastern Time Press Release SOURCE: MedImmune, Inc. MedImmune Completes Enrollment in Clinical Trials For Synagis(R) and Siplizumab GAITHERSBURG, Md., Dec. 27 /PRNewswire/ -- MedImmune, Inc. (Nasdaq: MEDI - news) announced today the completion of enrollment in two previously announced clinical trials for Synagis (palivizumab), a product that prevents serious respiratory syncytial virus (RSV) disease in certain high-risk infants, and siplizumab, a drug being developed as a potential psoriasis treatment. For Synagis, 1,287 infants under 24 months of age with congenital heart disease (CHD) have been enrolled in a Phase III study, dosing for which should complete in the second quarter of 2002. For siplizumab, 420 psoriasis patients have been enrolled in a Phase II study. Dosing is projected to be complete during the first quarter of 2002. ``We are very pleased with the continued progress of our pipeline,'' said Dr. Franklin Top, MedImmune's executive vice president and medical director. ``We remain focused on both expanding the label of our current products and bringing new and important products to market. As such, we hope that the data from the Synagis cardiac trial may provide support for the use of the drug in children throughout the world suffering with CHD who are at an increased risk of hospitalization due to RSV infection. Additionally, we continue to accumulate an increasing amount of data on the safety and efficacy of siplizumab in psoriasis as we target the initiation of Phase III clinical testing in 2002.'' [snip] The Phase II siplizumab study is a randomized, double-blind, placebo- controlled trial involving patients with plaque psoriasis on at least 10 percent of their body surface area and a minimum PASI (Psoriasis Area and Severity Index) score of eight. In this study, eligible patients are randomized to receive one of three regimens of siplizumab or placebo. The study, initiated in September 2001, is being conducted at 44 centers in North America and is designed to compare the safety and disease activity (PASI) in each of the groups. [snip] About Siplizumab Siplizumab is a humanized monoclonal antibody that binds to the CD2 receptor found on the surface of T-cells and natural killer (NK) cells. By binding to CD2, siplizumab selectively suppresses the function of T-cells and NK cells. T-cells are an essential part of the pathophysiology of psoriasis, and it is believed that modulation of T-cell activities may be therapeutically advantageous in the treatment of psoriasis. Psoriasis is a chronic illness affecting as many as six million Americans. Annual outpatient costs in the U.S. for psoriasis management have been estimated to be more than $1 billion. MedImmune has a comprehensive development program underway with siplizumab. Currently, the company has three Phase II trials underway, all now fully enrolled: a randomized, double-blind, placebo-controlled, subcutaneous administration trial involving 420 patients at 44 sites in North America; a randomized, double-blind, placebo-controlled, intravenous administration trial involving 124 patients at approximately 25 sites in North America; and a randomized, double-blind, subcutaneous administration trial involving 121 patients at approximately 20 sites in Europe. Data from MedImmune's Phase I program was presented in September at the European Society of Dermatology Research meeting held in Stockholm, Sweden, which built upon the preliminary data presented in San Francisco in June at the International Psoriasis Symposium and European Congress on Psoriasis. The updated data provided longer-term safety analysis for two trials using intravenous administration, as well as clinical data from a subcutaneously administered trial. Overall in these studies, siplizumab was found to be generally well tolerated, and was shown to improve psoriatic disease as measured by PASI score given either intravenous or subcutaneous administration. The follow-up of patients in the Phase I program was consistent with the preliminary safety and clinical results, and showed that improvement in patients' psoriasis appears to be durable after completion of treatment at least through the initial three month follow-up period in these trials. [snip] Emphasis mine. Jason