Navigation Links
Targanta Initiates Phase 2 Oritavancin Infrequent Dosing Study
Date:9/13/2007

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 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, Quebec, Canada and Toronto, Ontario, Canada. For further information about Targanta, visit the company's website at http://www.targanta.com.

Disclaimer

All forward-looking statements and other information included in this press release are based on information available to Targanta as of the date hereof, and Targanta assumes no obligation to update any such forward-looking statements or information. Targanta's actual results could differ materially from those described in Targanta's forward-looking statements.


'/>"/>
SOURCE Targanta Therapeutics Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Targanta Study Shows Oritavancin Treatment Effective in a Mouse Model of Anthrax
2. Targanta Reports Improved Ability of Oritavancin to Stop Bacteria Growth In Vitro Compared With Other Glycopeptide Antibiotics
3. Malvern initiates European user group meetings for chemical imaging
4. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
5. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
6. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/26/2017)... PROVIDENCE, N.J. , April 26, 2017 Phoenix ... announce its fifteenth year of fulfilling its mission of transforming ... industry is highly scrutinized, Phoenix,s innovative ... the healthcare community about the latest advances in science and ... Phoenix was founded in 2002 by ...
(Date:4/21/2017)... 21, 2017 Halo Labs announces the launch ... analysis system called the Horizon at PEGS 2017 in ... new system analyzes sub visible particulate matter in biopharmaceutical ... screening as early as candidate selection and pre-formulation. ... contract research organization Elion Labs for system ...
(Date:4/20/2017)... DUBLIN , April 20, 2017 ... the "Global Biosimilar Pipeline and Market Prospects: Addressing ... report to their offering. ... "Global Biosimilar Pipeline and Market ... by Design" provides an in-depth assessment of the current ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... April 28, 2017 , ... GlycoMark, Inc. announced ... test throughout the Northeast U.S. , GlycoMark is the only clinically available ... test provides a clinically proven one- to two-week measure of hyperglycemic excursions, often ...
(Date:4/28/2017)... ... 28, 2017 , ... Children and adolescents who enter the ... children in the general population. That’s because foster care is designed to protect ... While no fault of their own, youth who have experienced trauma often have ...
(Date:4/28/2017)... ... April 28, 2017 , ... Bill Howe started his sewer and drain ... After Tina Howe joined the team, the Bill Howe brand was born and they ... rates, and giving back to the San Diego community in which they worked, lived ...
(Date:4/28/2017)... ... April 28, 2017 , ... Woolsy Corporation ... supplements, through its Nova Skin Sciences division, recently announced the launch of Allumière ... with the power of an anti-aging concentrate. , Anogeissus Leiocarpa Bark ...
(Date:4/27/2017)... ... 27, 2017 , ... Today, Jefferson Health in Philadelphia and ... an agreement to create the Jane and Leonard Korman Respiratory Institute in Philadelphia. ... Korman Family Foundation. The collaboration leverages the strengths of each organization and will ...
Breaking Medicine News(10 mins):