Targanta Therapeutics Corp (MM) (NASDAQ:TARG)
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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, Québec,
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.