(Nasdaq: RDYN) announced that in preclinical studies, its
antibacterial candidate REP3123 is shown to inhibit growth and prevent
spore-forming of the Gram-positive Clostridium difficile (C. difficile)
bacterium without inhibiting other key organisms that are essential for
normal intestinal functioning. C. difficile-associated disease (CDAD), a
major cause of morbidity among the elderly and hospitalized patients, is
acquired by ingesting spores present in the environment that then grow and
multiply in the gut. In preclinical studies, REP3123 was superior to two
agents widely used to treat C. difficile infections, vancomycin and
metronidazole, in preventing the organism from forming spores. The study
results suggest that REP3123 has the potential to reduce the presence of
spores in the intestine, subsequently preventing dissemination into the
environment, thereby potentially reducing outbreak and relapse rates.
These results will be presented on Thursday, September 20, 2007 at
10:00 AM in Room E253D by Ian A. Critchley, Ph.D., Executive Director,
Microbiology at Replidyne during poster session 229 titled, "New Agents
Active Against Clostridium difficile" at the 47th Annual Interscience
Conference on Antimicrobial Agents and Chemotherapy held at the McCormick
Place conference center in Chicago.
REP3123 is a new narrow spectrum antibacterial agent that in vitro
prevents the growth of C. difficile by inhibiting an essential enzyme in
the bacterial cell called methionyl tRNA synthetase, which blocks the
organism from synthesizing proteins. Methionyl tRNA synthetase is a novel
target that has not been previously exploited by antibiotics and REP3123
shows no cross-resistance to currently marketed antibacterial agents. To
determine the ability of REP3123 to prevent sporulation of C. difficile,
four clinical isolates were studied including two epidemic BI/NAP1/027
strains identified in recent outbreaks in Quebec, Canada. The BI/NAP1/027
outbreak strains produce greater amounts of toxins A and B, have increased
sporulation capacity, and cause more severe disease and increased morbidity
and mortality. All bacterial strains were grown in the presence of low
concentrations (sub-minimum inhibitory concentrations or MICs) of either
REP3123, vancomycin or metronidazole. Spores were quantified after 96 hours
of drug exposure. All four strains of C. difficile varied in their ability
to produce spores under the conditions evaluated in this study. At 0.5
times the MIC, REP3123 was the most effective agent at preventing the
production of spores in all strains (equal to or less than 1% of spores
after 96 hours of treatment). In contrast, sub-MICs of metronidazole
promoted spore formation in three strains and vancomycin promoted
sporulation in two strains. The ability of REP3123 to inhibit sporulation
was concentration-dependent, with no spores detected at concentrations of
0.5 times the MIC. The FDA has not approved REP3123 for marketing in this
or any other indication.
"CDAD is a challenging disease for many reasons, including the
difficulty associated with eradication of Clostridium difficile and its
spores from the environment," explained Stuart Johnson, M.D., Associate
Professor of Medicine, Stritch School of Medicine, Loyola University and
the Hines VA Medical Center in Chicago. "These results demonstrating that
REP3123 has a direct impact on inhibiting spore-formation of C. difficile
bacteria are highly promising and clinically relevant."
"Through a novel mechanism of action that inhibits growth and targets
both sporulation and toxin production, REP3123 could be a future treatment
option that tackles the main challenges associated with treating CDAD: high
rates of relapse and new outbreaks," stated Kenneth J. Collins, Replidyne's
President & CEO. "We are excited by the potential of REP3123 and look
forward to its further development."
About Clostridium difficile
C. difficile is a Gram-positive anaerobic bacterium that causes C.
difficile-associated disease (CDAD). According to the Centers for Disease
Control and Prevention, CDAD is on the rise worldwide, both in terms of
number of cases and severity of the disease. Most cases of CDAD occur in a
hospital setting due to increased use of antibiotics and other
chemotherapeutics that disrupt normal intestinal flora, an ageing
population, and difficulty of eradicating C. difficile spores. However,
more recently, CDAD has been acquired in the community setting where
several outbreaks with increased mortality have occurred. The emergence of
an epidemic, hypervirulent C. difficile strain (BI/NAP1, 027) that produces
high levels of toxins poses a real threat to public health and demands
improved infection control as well as novel treatment options.
About Replidyne, Inc.
Replidyne is a biopharmaceutical company focused on discovering,
developing, in-licensing and commercializing innovative anti-infective
products. Replidyne's lead product, faropenem medoxomil, is a novel oral,
community antibiotic, expected to be appropriate for use as a first-line
antibiotic for treatment of respiratory and skin infections in adult and
pediatric patients. Replidyne's second drug candidate, REP8839, is a
topical anti-infective product candidate in development for the treatment
of skin and wound infections, including methicillin-resistant S. aureus
(MRSA) infections. Replidyne's investigational antibacterial agent REP3123
targets Gram-positive C. difficile bacteria and related diseases. In
preclinical studies, REP3123 has been show to inhibit growth, toxin
production and spore-forming in C. difficile bacteria. Replidyne is also
pursuing the development of other novel anti-infective programs based on
its in-house discovery research.
Safe Harbor
This press release contains plans, intentions, objectives, estimates
and expectations that constitute forward-looking statements about
Replidyne, Inc. that involve significant risks and uncertainties. Actual
results could differ materially from those discussed due to a number of
factors including, the success and timing of pre-clinical studies and
clinical trials; the Company's ability to obtain a new partner for
faropenem on acceptable terms; the Company's ability to obtain and maintain
regulatory approval of product candidates and the labeling under any
approval that may be obtained; plans to develop and commercialize product
candidates; the loss of key scientific or management personnel; the size
and growth of the potential markets for the Company's product candidates
and the Company's ability to serve those markets; regulatory developments
in the U.S. and foreign countries; the rate and degree of market acceptance
of any future products; the accuracy of Company estimates regarding
expenses, future revenues and capital requirements; the Company's ability
to obtain and maintain intellectual property protection for our product
candidates; the successful development of the Company's sales and marketing
capabilities; the success of competing drugs that are or become available;
and the performance of third party manufacturers. These and additional
risks and uncertainties are described more fully in the Company's most
recent Form 10-Q filed with the SEC under the Securities Exchange Act of
1934. Copies of filings made with the SEC are available through the SEC's
electronic data gather analysis and retrieval system (EDGAR) at
sec. All forward-looking statements made in the press
release are made as of the date hereof and the Company assumes no
obligation to update the forward-looking statements in the document.
Replidyne, Inc.
replidyne
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