To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: IDSA: Experimental Quinolone Cures Almost all Patients with Acute Bacterial Maxillary Sinusitis URL: http://www.pslgroup.com/dg/20C0B2.htm Doctor's Guide October 29, 2001
By Ed Susman Special to DG News
SAN FRANCISCO, CA -- October 29, 2001 -- The once daily treatment of bacterial maxillary sinusitis with the experimental quinolone, BMS-284756, appears to eradicate pathogens in more than 90 percent of patients during the 10-day course of therapy.
"We believe we achieved proof of principle that this drug is effective against sinusitis and is well tolerated by patients," said Dr.Paul Hale, PhD, a medical research director for Bristol-Myers Squibb, in Princeton, New Jersey, United States.
"We saw nothing unusual in the adverse clinical event profile with BMS-284756, and that is a good thing," he said at the 39th annual meeting of the Infectious Diseases Society of America (IDSA).
In the study, sponsored by Bristol-Myers Squibb, researchers in Mexico and Slovakia administered the new drug, a novel des-F(6)-quinolone, to 281 subjects in an open-label, multicenter, noncomparative trial.
The patients had an average age 40 years; 58 percent were women; three-fourths of the subjects were Caucasian, and 20 percent were Hispanic. They all presented with clinical signs and symptoms as well as radiologic signs of acute bacterial maxillary sinusitis. They received 400 mg of BMS-284756 once a day.
Of the 266 evaluable subjects, the researchers said that 91 percent were cured.
When analyzed by type of pathogen, 93 percent of patients (39 of 42 subject) infected with Streptococcus pneumoniae were cured; 26 of 28 patients (93 percent) with Haemophilus influenzae achieved a cure; 12 of 14 patients (86 percent) with Moraxella catarrhalis were cleared of the infection; 31 of 34 people (91 percent) with Staphylococcus aureus were cleared; all 17 patients (100 percent) infected with Haemophilus parainfluenzae had the infection eradicated.
The drug also proved effective in patients who were infected with penicillin resistant pathogens and against beta-lactamase producing strains of H influenzae and M catarrhalis.
Dr. Hale said the drug is now in Phase III studies, and the company expects to seek regulatory approval next year.
About 21 percent of patients-a total of 59-reported some adverse clinical events, the major ones being nausea in 11 subjects. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.