Has anyone heard anything about this ???
John
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Investigational Antibiotic Ceftobiprole Shows Promise Against
Potentially Life-Threatening MRSA Infections
Main Category: MRSA / Drug Resistance News
Article Date: 30 Sep 2006 - 0:00am (PDT)
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* Clinical Trials / Drug Trials
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Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
today announced that ceftobiprole, a novel cephalosporin(1) antibiotic
in Phase III clinical trials, was found to be active against
complicated skin infections caused by common, potentially deadly
bacteria, including MRSA. These data were from two poster
presentations given at the 46th Annual Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC). These data also were
highlighted by ICAAC. Ceftobiprole is being co-developed with Basilea
Pharmaceutica, Ltd. through an exclusive worldwide collaboration.
MRSA, which is the abbreviation for methicillin-resistant
Staphylococcus aureus, is a growing public health threat both in
hospital and community settings. While historically a cause of serious
infections in hospitalized patients, it has become an increasingly
common source of life-threatening infections in otherwise healthy people.
In the first presentation(2), ceftobiprole demonstrated high clinical
cure rates comparable to a commonly used antibiotic, vancomycin, in
treating patients with complicated skin and skin structure infections
(cSSSI) due to Gram-positive bacteria, including MRSA. The primary
objective of the study was to compare clinical cure rates 7-14 days
after completion of therapy in patients given ceftobiprole (500 mg IV
q 12hr) or vancomycin (1gm q IV 12hr).
In the second presentation(3) describing the baseline pathogens
(bacteria) seen in the cSSSI study, ceftobiprole was microbiologically
active against a wide range of both Gram-positive(4) and
Gram-negative(5) bacteria, including many bacteria associated with
common, serious skin infections.
"These trial data suggest that as an investigational broad-spectrum
antibiotic, ceftobiprole is effective in treating patients with skin
infections, including MRSA infections, a growing public health problem
both inside and outside hospital settings," said Gary J. Noel, M.D.,
Senior Director of Clinical Research and Development, Johnson &
Johnson Pharmaceutical Research and Development, L.L.C., who presented
the findings.
Study Results
The first presentation described a large, multi-center, randomized,
double-blind clinical trial involving 784 patients with cSSSI in whom
Gram-positive pathogens were documented and/or suspected based on
microscopic examination. Forty-eight percent of the patients had
abscesses and 33% had wound infections. Enrollment was stratified by
patient type.
Cure rates in the ceftobiprole-treated (n=61) and vancomycin-treated
(n=60) subjects in the clinically evaluable population with MRSA
infections were 91.8% and 90.0% respectively. Overall cure rates in
the ceftobiprole- treated (n=282) and vancomycin-treated (n=277)
subjects in the clinically evaluable population were 93.3% and 93.5%
respectively.
Serious treatment-related adverse events were 1% in the ceftobiprole-
treated population and 3% in the vancomycin-treated population. The
overall number of non-serious, treatment-emergent adverse events were
similar. Adverse events associated with rashes (e.g. pruritis,
erythema) occurred in 14% of vancomycin-treated subjects and in 9% of
ceftobiprole-treated subjects. Nausea was reported by 14% of
ceftobiprole-treated and 8% of vancomycin-treated patients. Taste
disturbance was reported by 8% of ceftobiprole-treated and 1% of
vancomycin-treated patients. Of the subjects who had normal serum
creatinine levels at baseline, 4% of vancomycin-treated subjects had
abnormal serum creatinine values during the study compared with 2% of
ceftobiprole- treated subjects.
Discontinuation of therapy due to treatment-related adverse events was
comparable in both groups (with 3% in ceftobiprole-treated subjects
and 4% in vancomycin-treated subjects).
In the second presentation, baseline pathogens from the cSSSI study
were examined for their susceptibility to ceftobiprole and selected
antimicrobial agents. The predominant pathogen was S. aureus, and, of
these staphylococcal isolates, 37% were methicillin-resistant. The
Gram-negative isolates were identified as Enterobacteriaceae,
Pseudomonas spp. and Acinetobacter baumannii. Among the baseline
pathogens, ceftobiprole inhibited all staphylococcal and streptococcal
isolates at clinically achievable concentrations.
In addition to these Phase III study results, data from multiple
surveillance studies(6) are being presented demonstrating the
broad-spectrum antibacterial activity of ceftobiprole against
potentially life-threatening Gram-positive and Gram-negative isolates,
including Enterobacteriaceae and Pseudomonas aeruginosa.
About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
(J&JPRD) is part of Johnson & Johnson, the world's most broad-based
producer of healthcare products. J&JPRD is headquartered in Raritan,
New Jersey (USA), and has facilities throughout Europe and the United
States. J&JPRD is leveraging drug discovery and drug development in a
variety of therapeutic areas to address unmet medical needs worldwide.
Footnotes:
(1) Cephalosporins are a sub-class of antibacterial agents within the
Beta-lactam class. Beta-lactam antibiotics are used to treat many
different kinds of bacterial infections, including abdominal, ear,
respiratory (including pneumonia), urinary tract, and skin infections.
(2) "Successful Treatment of Complicated Skin Infections (cSSSI) Due
to Staphylococci, Including Methicillin-Resistant Staphylococcus
aureus (MRSA) with Ceftobiprole" (Poster L-1212)
(3) "Ceftobiprole Activity against Baseline Pathogens from a
Complicated Skin and Skin Structure Infection Clinical Trial" (Poster
E-0116)
(4) Gram-positive indicates a group of bacteria that become
violet-colored when the bacterial cells are treated with the Gram
stain. This response is based on the chemical composition of their
cell walls and is used to identify the type of bacteria. Some
Gram-positive bacteria may cause serious infections.
(5) Gram-negative indicates a group of bacteria that become red when
the bacterial cells are treated using the Gram stain method. This
response is based on the chemical composition of their cell walls and
is used to identify the type of bacteria. Some Gram-negative bacteria
may cause serious infections.
(6) "Baseline Surveillance Profiles of Ceftobiprole (BPR) Activity
Against Enterobacteriaceae and P. Aeruginosa (PA)" (Poster E-0122);
"In vitro Activity of Ceftobiprole Tested Against a Recent Collection
of North American Pseudomonas aeruginosa (PSA)" (Poster E-0115);
"Susceptibilities of Most Prevalent Enterobacteriaceae-species to
Ceftobiprole: Results of The Antimicrobial Resistance Surveillance
Study of the Paul Ehrlich Society for Chemotherapy, 2004" (Poster E-0117).
Johnson & Johnson Pharmaceutical Research and Development
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