�Targanta Therapeutics Corporation (Nasdaq: TARG) announced positive top-line results from a Phase 2 clinical trial investigating the efficacy and safety 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 prospect targeting gram-positive organisms, including methicillin-resistant Staphylococcus aureus, or MRSA. Oritavancin, administered in a single or in an infrequent dosing regime, demonstrated like efficacy and safety to a three-to-seven day line of oritavancin therapy, as administered in two antecedently conducted Phase 3 clinical trials for the treatment of cSSSI. Each of these Phase 3 clinical trials met their primary endpoint.
These top-line efficacy results from SIMPLIFI ar consistent with Targanta's antecedently published preclinical studies. The SIMPLIFI trial run was intentional based on oritavancin's unique pharmacokinetic profile and demonstrated concentration-dependent bactericidal activity.
Mark Leuchtenberger, President and CEO of Targanta, commented, "We believe the potential to cure cSSSI with simply a single or infrequent dosing regimen could make oritavancin the go-to drug of pick among physicians who ar seeking an effective and convenient weapon for their antibiotic armamentarium, and thereby lead to a dislodge in the treatment image for gram-positive infections. With the SIMPLIFI results in hand, we will set about to purpose a bigger confirmatory tribulation that could demonstrate oritavancin's potential as the market's first good single or infrequent endovenous (IV) treatment of cSSSI caused by gram-positive bacterium."
Results of the Phase 2 SIMPLIFI trial volition be victimized to designing a Phase 3 written report to appraise the benefits and risks of a single-dose regime for the treatment of cSSSI. Targanta expects full data from SIMPLIFI volition be presented prior to the final stage of the year.
About SIMPLIFI
The Phase 2 SIMPLIFI test was an international, multi-center, randomized, double blind, controlled subject area of some 300 patients with cSSSI, including MRSA. SIMPLIFI measured clinical response to oritavancin (either cure or improvement versus bankruptcy) at the first followup visit (Test of Cure) in clinically evaluable patients as its primary terminus. The survey examined the safety of oritavancin in all intent-to-treat patients as its junior-grade endpoint.
Additional details around the SIMPLIFI trial design can be found in a press release dated May 20, 2008, "Targanta Completes Enrollment in Phase 2 Oritavancin Infrequent Dosing Study," set up on the Investor Relations section of Targanta's site at world Wide Web.targanta.com/investors/newsrelease.html.
About Oritavancin
Oritavancin is a novel man-made lipoglycopeptide antibiotic drug candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. In its intravenous (IV) formulation, the production candidate has been tried and true in over 2,four hundred individuals and has realised two Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI) in which the primary endpoints were met. 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 recognised the NDA submission for standard review, establishing an action day of the month of December 8, 2008. Targanta's Marketing Authorization Application (MAA) for oritavancin was accepted for review by the European Medicines Agency (EMEA) in June 2008. Targanta is also development an oral version of oritavancin for the possible treatment of Clostridium difficile-related conditions.
About Targanta Therapeutics
Targanta Therapeutics Corporation (Nasdaq: TARG) is a biopharmaceutical company focussed on development and commercializing innovative antibiotics to do by serious infections in the hospital and other institutional settings. The Company's word of mouth includes an intravenous version of oritavancin, a semisynthetic lipoglycopeptide antibiotic currently awaiting U.S. and EU regulatory approval, and, a computer programme to develop an oral version of oritavancin for the handling of Clostridium difficile. The Company has operations in Cambridge, MA, Indianapolis, IN, and Montreal, Qu�bec, Canada. For more than information on Targanta, visit http://www.targanta.com.
Safe Harbor Statement
This press outlet contains "forward-looking statements" that are made pursuant to the safe harbor viands of the Private Securities Litigation Reform Act of 1995. These are statements that ar predictive in nature, that depend upon or refer to future events or conditions or that include words such as "potential," "may," "will," "expects," "projects," "anticipates," "estimates," "believes," "intends," "plans," "should," "seeks," "hope" and alike expressions. Such statements include, but are not limited to the potential to cure cSSSI with exactly a undivided or infrequent dosing regimen of oritavancin; oritavancin seemly the antibiotic drug of choice among physicians; and oritavancin's potency as the market's number one effective, single or infrequent intravenous (IV) infusion for treatment of cSSSI caused by gram-positive bacteria. Forward-looking statements involve known and unknown risks and uncertainties that crataegus oxycantha cause literal future results to differ materially from those sticking or contemplated in the forward-looking statements. Forward-looking statements may be significantly wedged by certain risks and uncertainties described in Targanta's filings with the Securities and Exchange Commission. The risks and uncertainties referred to higher up include, just are not limited to, delays in obtaining or a failure to obtain regulatory blessing for Targanta's product candidates; unfavorable clinical trial results; Targanta's potentiality inability to initiate and complete presymptomatic studies and clinical trials for its product candidates; the possibility that results of preclinical studies are not necessarily predictive of clinical trial results; and those other risk factors that are described more fully in the Company's filings with the Securities and Exchange Commission. Targanta does non undertake any obligation to update whatsoever of these forward-looking statements to reverberate a variety in its views or events or circumstances that occur after the date of this release.
Targanta Therapeutics
More information
