Targanta Presents Preclinical In Vivo Data Demonstrating Activity of Oritavancin against Clostridium Difficile Infection
25 Octubre 2008 - 11:15AM
Business Wire
Targanta Therapeutics Corporation (NASDAQ: TARG) today released the
in vivo data from a preclinical study comparing the activity of its
antibiotic drug candidate, oritavancin, to vancomycin in a hamster
model of Clostridium difficile infection. Results are being
presented in a poster (B-067) today at 12:15 pm EDT entitled,
�Efficacy of Oritavancin against Clostridium difficile (CD)
infection in the Hamster Model of CD infection (CDI)� 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. In the study, oritavancin activity at 10, 50 and
100 mg/kg/day and a pegylated (PEG400) formulation of oritavancin
at 100 mg/kg/day were compared to vancomycin activity at 50
mg/kg/day against clindamycin-induced C. difficile infection in
Golden Syrian hamsters. The Golden Syrian hamster model is widely
recognized as the gold standard for C. difficile infection. The
hamsters were treated orally for 5 days and their progress measured
for a total of 20 days. Results showed that all doses of
oritavancin were highly effective in prolonging survival compared
to untreated controls, and prevented relapse longer than treatment
with vancomycin at equivalent dose. Oritavancin at 100 mg/kg
exhibited superior efficacy to vancomycin at day 12: 100% survival
was observed for animals treated with oritavancin compared to 0%
survival with vancomycin. The PEG400 formulation of oritavancin
protected all hamsters from relapsing, yielding 100% survival out
to day 20, compared to vancomycin (0% survival). These data are
consistent with previously presented results from in vitro gut
model studies demonstrating that, while both oritavancin and
vancomycin were effective in treating clindamycin-induced C.
difficile infection, only oritavancin appeared active against the
spore forms of the bacteria, suggesting that oritavancin may
prevent recurrence of disease. Targanta plans to continue advancing
this program and initiating additional studies that would possibly
enable the testing of orally-administered oritavancin for the
treatment of C. difficile in the first half of 2009. About C.
difficile C. difficile are anaerobic, gram-positive, spore-forming
bacteria that are a major cause of morbidity in the hospitalized
elderly. Recent studies estimate that currently there may be as
many as 500,000 cases of C. difficile infection occurring annually
in the United States, contributing to between 15,000 and 30,000
deaths.1 C. difficile infection is associated with production of
toxins in the colon, resulting in disease ranging from
uncomplicated diarrhea to severe pseudomembranous colitis. The
later more severe disease can be complicated by toxic megacolon,
requiring removal of the colon, and sometimes results in death. It
is postulated that after the normal gut flora balance is
compromised or eradicated by the use of antibiotics, C. difficile
spores refractory to current antimicrobial therapies persist,
causing recurrent infections. 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. 1 CDC Congressional Testimony, United States
Senate Committee on Health, Education, Labor and Pensions, Tuesday,
June 24, 2008 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. Such statements
include, but are not limited to the suggestion that oritavancin may
prevent recurrence of C. difficile infection, and the possible
testing of orally-administered oritavancin for the treatment of C.
difficile infection in the first half of 2009. 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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