Preliminary Data Show MedImmune's Siplizumab Well-Tolerated

MedImmune has announced preliminary Phase I clinical trial results of siplizumab indicating the antibody was safe and well-tolerated in patients with certain T-cell lymphomas and leukemias.

Siplizumab is a development-stage monoclonal antibody being evaluated in adults with CD2-positive lymphoma or leukemia. The primary objectives of the study, titled "Phase 1 Trial of Siplizumab in CD2-Positive Lymphoproliferative Disease," are to determine the maximum-tolerated dose and safety and tolerability of siplizumab in patients with CD2-positive lymphoproliferative disorders, including CD2-postive peripheral T-cell lymphoma, adult T-cell leukemia/lymphoma, cutaneous T-cell lymphoma and large granular lymphocytic leukemia.

The trial is designed to include cohorts of three patients each who receive escalating doses of siplizumab intravenously every other week for 16 weeks or until unacceptable toxicity or disease progression.