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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (329)	1/22/2003 8:23:49 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 631

From label: Drug Interactions MTX reduced adalimumab apparent clearance after single and multiple dosing by 29% and 44% respectively. Immunogenicity Patients in Studies I, II, and III were tested at multiple time points for antibodies to adalimumab during the 6 to 12 month period. Approximately 5% (58 of 1,062) of adult rheumatoid arthritis patients receiving HUMIRA developed low-titer antibodies to adalimumab at least once during treatment, which were neutralizing in vitro. Patients treated with concomitant MTX had a lower rate of antibody development than patients on HUMIRA monotherapy (1% versus 12%). No apparent correlation of antibody development to adverse events was observed. With monotherapy, patients receiving every other week dosing may develop antibodies more frequently than those receiving weekly dosing. In patients receiving the recommended dosage of 40 mg every other week as monotherapy, the ACR 20 response was lower among antibody-positive patients than among antibody-negative patients. The long-term immunogenicity of HUMIRA is unknown. The data reflect the percentage of patients whose test results were considered positive for antibodies to adalimumab in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to adalimumab with the incidence of antibodies to other products may be misleading.

To: Icebrg who wrote (329)	1/30/2003 7:50:39 AM
From: Icebrg	Read Replies (1) \| Respond to of 631

Alexion Completes Enrollment in Phase IIb Trial of Eculizumab in Rheumatoid Arthritis Patients Thursday January 30, 7:31 am ET CHESHIRE, Conn., Jan. 30 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals Inc. (Nasdaq: ALXN - News) announced today that it has completed enrollment in its Phase IIb trial of eculizumab, a humanized monoclonal antibody C5 complement inhibitor, in rheumatoid arthritis patients. The trial is designed to assess the safety and efficacy of eculizumab and to confirm the drug's most efficacious dosing regimen. The trial enrolled approximately 350 patients at 69 centers in the U.S. and Canada who are being treated concomitantly with disease-modifying anti-rheumatic drugs. "Completing enrollment of this eculizumab Phase IIb rheumatoid arthritis trial is an important step in the development of eculizumab in this disease," stated Leonard Bell, M.D., Chief Executive Officer of Alexion. "In this larger patient study, we are treating patients for a six month period, and seek to confirm the promising clinical data obtained in our earlier eculizumab Phase IIa rheumatoid arthritis study. Importantly, we hope to obtain further information on the durability of response. Once the six month treatment period, all follow-up patient visits, and data collection are completed, we expect to analyze the data and report the results of this Phase IIb trial." This double-blind, randomized, placebo-controlled Phase IIb trial has enrolled approximately 350 patients with mild to moderate disease undergoing treatment with moderate doses of methotrexate or leflunomide. The trial consists of three treatment arms. Patients are treated with placebo; eculizumab intravenous injection once per week for four weeks and then once every month; or eculizumab intravenous injection once per week for four weeks and then once every two weeks. The patients will be evaluated after a six month treatment period for safety and efficacy, and the primary efficacy endpoint will be improvement in the ACR20 score.