Targanta Presents Efficacy & Safety Data for Oritavancin for the Treatment of Gram-Positive Complicated Skin & Skin Structure...
26 Octubre 2008 - 10:15AM
Business Wire
Targanta Therapeutics Corporation (NASDAQ: TARG) today announced
the presentation of key clinical findings of its lead antibiotic
drug candidate, oritavancin, at the combined annual meetings of the
48th Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) and the 46th Infectious Disease Society of
America (IDSA), taking place in Washington, DC. The presentations
highlight the efficacy and safety results of two Phase 3 clinical
studies of oritavancin. Sunday, October 26, 2008 at 12:15 p.m. EDT
Oritavancin Demonstrated Efficacy with 3-7 Day Therapy in Two Phase
3 Trials for cSSSI Poster L-1514 is entitled, �Oritavancin in the
treatment of complicated skin and skin structure infections
(cSSSI): Combined results of two Phase 3 multinational trials.�
This presentation reviews the efficacy and safety results of two
randomized, double-blind, multicenter, Phase 3 trials designed to
test whether 3 to 7 days of oritavancin was non-inferior to 10 to
14�days of vancomycin/cephalexin in the treatment of gram-positive
cSSSI, including those caused by methicillin-resistant
Staphylococcus aureus (MRSA). Inclusion criteria allowed patients
with diabetes, renal or hepatic insufficiency, and HIV/AIDS to be
enrolled. In these studies, oritavancin demonstrated comparable
efficacy to vancomycin. Oritavancin had a favorable safety profile
compared to vancomycin with fewer patients experiencing adverse
events (AEs) or discontinuation from the study due to an AE.
Adverse events were generally mild to moderate in nature with
nausea, headache and pruritis being the most common drug-related
AEs in oritavancin patients, and pruritis and vomiting in
vancomycin patients. Oritavancin was Associated with Fewer
Histamine-like Infusion Reactions Compared to Vancomycin Poster
L-1515 is entitled, �Incidence of Histamine-like Infusion Reactions
(HLIR) in 2 Phase 3 studies comparing oritavancin with vancomycin
in the treatment of complicated skin and skin structure
infections.� Histamine-like infusion reactions are a
well-recognized adverse effect of glycopeptide administration. This
study assessed the frequency and nature of HLIRs in two randomized,
double-blind phase 3 studies comparing oritavancin with
vancomycin/cephalexin in the treatment of cSSSI. The study showed
that when compared with vancomycin in the treatment of patients
with cSSSI, oritavancin was associated with a lower incidence of
HLIRs. About Oritavancin Oritavancin is a novel semi-synthetic
lipoglycopeptide antibiotic candidate with potent bactericidal
(killing) activity against a broad spectrum of gram-positive
bacteria. In its intravenous (IV) formulation, the product
candidate has been tested in over 2,400 individuals and has
completed 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 accepted the NDA submission for standard review,
establishing an action date 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 developing an oral version of oritavancin
for the possible treatment of Clostridium difficile. About Targanta
Therapeutics Targanta Therapeutics Corporation (Nasdaq: TARG) is a
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
an intravenous version of oritavancin, a semi-synthetic
lipoglycopeptide antibiotic currently awaiting U.S. and EU
regulatory approval, and a program to develop an oral version of
oritavancin for the treatment of Clostridium difficile. The Company
has operations in Cambridge, MA, Indianapolis, IN, and Montreal,
Qu�bec, Canada. For more information on Targanta, visit
www.targanta.com. Safe Harbor Statement This press release contains
�forward-looking statements� that are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. These are statements that are 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 similar expressions. Forward-looking
statements involve known and unknown risks and uncertainties that
may cause actual future results to differ materially from those
projected or contemplated in the forward-looking statements.
Forward-looking statements may be significantly impacted by certain
risks and uncertainties described in Targanta�s filings with the
Securities and Exchange Commission. The risks and uncertainties
referred to above include, but are not limited to, delays in
obtaining or a failure to obtain regulatory approval for Targanta�s
product candidates; unfavorable clinical trial results; Targanta�s
potential inability to initiate and complete pre-clinical studies
and clinical trials for its product candidates; the possibility
that results of pre-clinical 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 not undertake any obligation
to update any of these forward-looking statements to reflect a
change in its views or events or circumstances that occur after the
date of this release.
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