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Replidyne Announces Positive Phase I Results For Topical Antibiotic REP8839
Replidyne, Inc.
(Nasdaq: RDYN) today announced results from three Phase I trials studying
REP8839, a novel topical antibiotic that has shown potent in vitro activity
against major skin pathogens including methicillin-resistant S. aureus
(MRSA). The results of the Phase I trials show that topically applied
REP8839 appears safe, well-tolerated and associated with low systemic
exposure, or drug absorption into the bloodstream, which is desirable for a
topical antibiotic treatment. Based on these results, Replidyne plans to
initiate Phase II trials in children with impetigo, the most common
bacterial skin infection, by the end of the year.
"REP8839 is a promising development candidate and has the potential to
be an important treatment option for physicians in the ongoing fight
against drug-resistant infections including MRSA, a growing public health
concern," said Kenneth J. Collins, Replidyne's President and Chief
Executive Officer. "With these safety data, we intend to move forward into
Phase II trials to study the safety and efficacy of REP8839 in patients
with impetigo and other skin and wound infections."
REP8839 was tested in three Phase I trials which collectively enrolled
over 400 subjects. In the first Phase I trial, safety, tolerability and
skin irritancy were tested following repeated daily application of REP8839,
at three drug concentrations (1%, 2% and 4%), on intact and abraded skin.
Irritancy scores comparable to placebo were recorded for all REP8839
exposed test subjects. In the second study, in addition to safety,
tolerability and dermal irritancy, systemic exposure was examined following
repeated daily application of REP8839 on a larger surface area of intact
and abraded skin. In all subjects, REP8839 was associated with low systemic
exposure and low skin irritancy. In the third study, a 2% formulation of
REP8839 was tested for its ability to cause long-term sensitization and
irritancy. No sensitization reactions were recorded in any of the subjects,
and low irritancy potential was confirmed. Additionally, in all Phase I
studies no serious adverse events were observed in any study subject.
About REP8839
REP8839 is a novel topical antibacterial ointment that targets the
bacterial methionyl tRNA (MetRS) enzyme. MetRS is an unexploited target in
clinically-important Gram-positive bacteria and represents a promising
platform for the development of new antibacterial agents with no
cross-resistance to currently marketed antibiotics. In vitro, REP8839 is
highly active against major skin pathogens such as Streptococcus pyogenes
and Staphylococcus aureus (S. aureus), including drug-resistant strains
such as MRSA, mupirocin-resistant and vancomycin-resistant S. aureus.
About Impetigo
Impetigo is a contagious skin disorder caused by bacterial infection
and characterized by crusting, red skin lesions, most frequently affecting
children. It is the third most common skin disease in children, causing
peak incidence among those aged two to five years. Since 2004, the
incidence of impetigo has increased 21 percent. In 2006, topical antibioti c
prescriptions accounted for 48 percent of all impetigo treatments.
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 is also pursuing the development of other
novel anti-infective products 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 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 Form 10-K 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 http://www.sec.gov. 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.
http://www.replidyne.com
Replidyne anunta pozitiv de fazã I Rezultate pentru antibiotic topic REP8839 - Replidyne Announces Positive Phase I Results For Topical Antibiotic REP8839 - articole medicale engleza - startsanatate