Targanta Completes Enrollment in Phase 2 Oritavancin Infrequent Dosing Study
Tuesday May 20, 7:58 am ET
SIMPLIFI Examining Single- and Infrequent-Dosing Regimens in cSSSI
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Targanta Therapeutics Corporation (Nasdaq: TARG - News) today announced that enrollment has been completed in 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.
Mark Leuchtenberger, President and Chief Executive Officer of Targanta, commented on the event: “We are very pleased to have completed enrollment in SIMPLIFI on schedule and are looking forward to locking the database and analyzing the results over the next few months. We are optimistic that we will have data ready to submit to one of the major infectious disease meetings this fall and will be using these data to determine whether to pursue Phase 3 registration trials for infrequent dosing of oritavancin in the treatment of cSSSI.”
“As discussed previously,” Mr. Leuchtenberger continued, “we believe that, if demonstrated effective in pivotal, controlled trials and subsequently approved by regulatory authorities, a less frequent dosing regimen for oritavancin could be a major advantage to the infectious disease community by providing flexible patient treatment options and could also confer pharmacoeconomic benefits through shorter hospital stays and reduced use of hospital resources.”
Targanta submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in February 2008 seeking to commercialize oritavancin for the treatment of cSSSI; the FDA has accepted the NDA submission for standard review, establishing an action date of December 8, 2008.
About SIMPLIFI
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 consisted of three treatment arms in which patients received either:
* 200 mg oritavancin delivered by intravenous (IV) administration 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 and currently under review by U.S. regulatory authorities);
* 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 is measuring clinical response (either cure or improvement versus failure) in clinically evaluable patients. As a secondary endpoint, this study is examining safety data in all intent-to-treat patients. Over 300 patients were enrolled in the study.
surf's up......crikey
