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Targanta Initiates Phase 2 Oritavancin Infrequent Dosing Study |
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14 Sep 2007 |
SIMPLIFI to Examine Single-Dose and Infrequent-Dosing Regimens in cSSSI
CAMBRIDGE, MA | September 13, 2007 | 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 submissions for oritavancin based on the two Phase 3 cSSSI studies completed to date.”
Mark Leuchtenberger, President and Chief Executive Officer of Targanta, commented on the study: “If successful, we believe a less frequent dosing regimen for oritavancin could confer pharmacoeconomic benefits through shorter hospital stays and reduced use of hospital resources. In addition, our market research has indicated that simplified dosing regimens such as those tested here, if proven equally effective, could become invaluable to the infectious disease community by providing flexibility to optimize dosing to suit specific patient needs.”
About Oritavancin
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. The product candidate has been tested in over 1500 patients and has completed two Phase 3 studies for the treatment of complicated skin and skin structure infection (cSSSI) in which the primary endpoints were met. Targanta believes oritavancin's properties may give it distinct advantages over currently marketed therapies and expects to submit a New Drug Application to the U.S. Food and Drug Administration in the first quarter of 2008 seeking to commercialize oritavancin for the treatment of cSSSI.
About Targanta Therapeutics
Targanta Therapeutics Corporation is a privately held biopharmaceutical company focused on developing and commercializing innovative antibiotics to treat serious infections in the hospital and other institutional settings. The Company’s pipeline includes oritavancin, a semi-synthetic lipoglycopeptide antibiotic, for which Targanta intends to seek U.S. regulatory approval in early 2008, as well as a number of antibacterial agents in pre-clinical development. The company has operations in Cambridge, MA, Indianapolis, IN, Montreal, Québec, Canada and Toronto, Ontario, Canada. For further information about Targanta, visit the company’s website at www.targanta.com .
SOURCE: TARGANTA THERAPEUTICS |
