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Tigecycline - Candidate antibiotic produces 74 percent cure rate in cSSSI patients

Results in Treatment of Hospital Patients with Complicated Skin Infections Reported in Clinical Therapeutics

Oklahoma City, OK An antibiotic, currently being tested in clinical trials, produced a 74 percent cure rate for hospitalized patients with possibly life-threatening, complicated skin and skin structure infections (cSSSI). Tigecycline, a candidate antibiotic drug, produced these promising results in a study led by Russell G. Postier, M.D., OU Physicians Chairman of Surgery and John A. Schilling Professor of Surgery at the University of Oklahoma College of Medicine.

"Tigecycline displayed promising efficacy against a wide spectrum bacteria commonly related to complicated skin infections, with an acceptable safety profile. These data warrant further investigation in blinded comparator clinical trials, said Postier, John A. Schilling Professor and chairman of surgery, OU Physicians and the study's principle investigator. Results of the multicenter, phase 2 will be published in the May 2004, issue of Clinical Therapeutics.

In the study, 85 percent of patients who received 50-milligram (mg) doses of tigecycline were cured at the end of their seven- to 14-day treatment, and 74 percent were cured at the test-of-cure visit (the study's primary outcome measure), about 21 days after their initial dose of tigecycline. Similarly, 78 percent of patients on the 25-mg doses were cured at the end of treatment, and 67 percent at the test-of-cure visit. The decline in rates directly resulted from patients receiving either additional antibiotics or surgery between the end of their treatments and their test-of-cure visits.

The 50 mg group also had a higher overall bacterial eradication rate at the end of therapy, 74 percent, than the 62 percent rate of the 25 mg group. At the test-of-cure visit, the rates were 70 and 56, respectively. Additionally, the trial used laboratory tests to document tigecycline activity against
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Contact: Jennifer Petra
jpetra@porternovelli.com
212-601-8110
Porter Novelli
23-May-2004


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