Ramoplanin Demonstrates High Activity Against Wide Array of Isolates of C. difficile, Including Emerging Strains; Data presented at 45th Interscience Conference on Antimicrobial Agents and Chemotherapy
WASHINGTON (Business Wire) -- Researchers at the 45th Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) have presented new data
today on the in vitro activity of several products and product
candidates against strains of Clostridium difficile (C. difficile),
including recently described epidemic strains that have shown
increased virulence. The data are among the first to report the in
vitro activity of these agents against the strains of C. difficile
suspected of causing recent cases of severe C. difficile-associated
disease (CDAD).
Oscient Pharmaceuticals' (Nasdaq: OSCI) lead product candidate,
Ramoplanin, a novel glycolipodepsipeptide antibiotic under development
for the treatment of CDAD, was among the agents tested. The posters
showed that Ramoplanin was highly active in vitro against all strains
tested at concentrations below those clinically achievable in human
trials and no resistance was observed.
"Several recent studies have documented the emergence of severe
CDAD cases across North America and in Europe, demonstrating the
urgent need for novel therapeutics for this epidemic," stated Dale
Gerding, M.D., Professor, Department of Medicine, Loyola University of
Chicago Stritch School of Medicine, lead author on one of the posters
and senior author of a recent New England Journal of Medicine article
examining isolates from the virulent outbreaks of CDAD. "Our research
examined C. difficile isolates from a broad international collection
assembled during the past two decades. In our study, Ramoplanin was
highly active against all of the isolates tested and holds potential
as a promising treatment for CDAD."
Dr. Gerding and colleagues tested over 100 distinct, clinical C.
difficile isolates from varying geographies collected over 20 years
and presented their findings in the poster, "In Vitro Activity of
Ramoplanin, Rifalazil, Rifaximin, Metronidazole, and Vancomycin
against 110 Unique Toxigenic Clostridium difficile Clinical Isolates"
(Poster E-1439/164). Rifalazil and rifaximin were the most potent
agents against the strains tested, but resistance to both agents in
some isolates was observed. At an MIC90 of 0.5 mcg/ml, Ramoplanin was
active against all isolates tested, including those strains associated
with the recent outbreak of C. difficile and the isolates resistant to
other agents.
In a separate poster entitled, "In Vitro Activities of 11
Antibiotics against Clostridium difficile Isolates Recovered in a
Montreal Hospital During Two Different Periods" (Poster E-1436/161),
Dr. A.C. Labbe and colleagues tested strains of C. difficile
associated with a recent outbreak in Canada and demonstrated that
Ramoplanin and rifampin exhibited the highest in vitro activity
against the bacteria. Importantly, Ramoplanin maintained high activity
(MIC90 0.25 mg/L) against all the strains collected both prior to and
during the epidemic in Canada.
"Based on Ramoplanin's excellent in vitro activity against C.
difficile, in conjunction with the favorable clinical response rates
observed in our Phase II trial of Ramoplanin versus vancomycin, we
believe that Ramoplanin may offer clinicians a much needed therapeutic
alternative for this increasingly frequent and virulent disease,"
stated Steven M. Rauscher, President and CEO of Oscient
Pharmaceuticals.
Taking place in Washington, D.C. from December 16-19, ICAAC is a
major scientific conference sponsored by the American Society for
Microbiology bringing together more than 12,000 scientists and
researchers from around the globe to address the impact of infectious
diseases.
About C. difficile-Associated Disease
[snip]
About Ramoplanin
Oscient Pharmaceuticals' Ramoplanin is an investigational new drug
being studied for the treatment of Clostridium difficile-associated
disease (CDAD). Existing preclinical data suggest Ramoplanin may have
potential in controlling several antibiotic-resistant, Gram-positive
bacteria such as vancomycin-resistant enterococci (VRE),
methicillin-resistant Staphylococcus aureus and vancomycin-resistant
Staphylococcus aureus. The antibiotic has also been shown to be
bactericidal in vitro against Clostridium difficile. Because it is not
absorbed systemically from the gastrointestinal (GI) tract following
oral dosing and exerts its bactericidal activity in the GI tract,
Ramoplanin represents a potential new method for managing certain
pathogens commonly found in the hospital.
About Oscient Pharmaceuticals
[snip] |
