SIMPLIFI to Examine Single-Dose and Infrequent-Dosing Regimens in cSSSI
CAMBRIDGE, Mass., Sept. 13 /PRNewswire/ -- Targanta Therapeutics Corporation today announced the initiation of its Phase 2 trial investigating the safety and efficacy of oritavancin at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (cSSSI), or SIMPLIFI. Oritavancin is Targanta's lead antibiotic candidate targeting gram- positive infections.
This Phase 2 study is an international, multi-center, randomized, double- blind, controlled study in patients with cSSSI presumed or proven to be caused by gram-positive pathogen(s). The study consists of three treatment arms in which patients will receive either:
-- 200 mg oritavancin IV daily for a minimum of 3 days and up to a maximum
of 7 days (the dosing regimen used in the larger of the two completed
Phase 3 studies of oritavancin in cSSSI);
-- A single dose of 1200 mg oritavancin IV; or
-- A single dose of 800 mg oritavancin IV, with a further dose of 400 mg
IV on Day 5 if needed.
As its primary endpoint, SIMPLIFI will measure clinical response (either cure or improvement versus failure) in clinically evaluable patients. As a secondary endpoint, this study will examine safety data in all intent-to-treat patients. Targanta expects to enroll a total of 300 patients in this study.
"Based on extensive pharmacokinetic and pharmacodynamic modeling, we
believe there is a high likelihood of success with the less frequent
oritavancin dosing regimens being studied here," said Pierre E. G. Etienne,
M.D. Chief Development Officer of Targanta. "We currently expect to
complete collection of clinical trial data from SIMPLIFI in the second half
of 2008, at which time we will assess the outcomes and determine whether to
pursue Phase 3 registration trials. In the meantime, we are working on the
preparation of our first U.S. and European regulatory s
|SOURCE Targanta Therapeutics Corporation|
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