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Rifalazil Trial (PROVIDENCE-1) Fails to Provide Significant Clinical Benefit in Patients With Peripheral Arterial Disease
Date:11/7/2007

LEXINGTON, Mass., Nov. 7 /PRNewswire/ -- ActivBiotics, Inc. today announced the results of its PROVIDENCE-1 clinical trial, which evaluated the effect of rifalazil in the treatment of intermittent claudication, associated with peripheral arterial disease (PAD). The results demonstrated that treatment for two months with the experimental antibiotic rifalazil did not result in a significant improvement in walking distance, claudication onset times, or other clinically-relevant parameters of PAD.

The results were presented earlier today at the late breaker Scientific Session at the American Heart Association's 2007 annual meeting in Orlando, Florida. Michael R. Jaff, DO, FACP, FACC, Assistant Professor of Medicine, Harvard Medical School and Medical Director, Massachusetts General Hospital Vascular Center, Boston, Massachusetts, Chair of the trial's Steering Committee, presented the data.

The prospective, randomized, double-blinded international study was done on an outpatient basis with the primary endpoint being a change in baseline peak walking time, comparing those given rifalazil against those given a placebo. The study enrolled 297 consenting men and women (40-80 years old) with diagnosis of intermittent claudication due to PAD who also had high levels of antibodies to C. pneumoniae. Researchers used treadmills and quality of life questionnaires to chart patients' progress at various times throughout the one-year study.

"We are clearly disappointed with the low efficacy signal seen in rifalazil-treated patients which was only 4% greater than placebo, a difference which was not statistically significant. On the other hand, we are pleased that the population demographics, low placebo response and overall low variability in this study provided a very clear cut answer," said Steven C. Gilman, Ph.D., Chairman and CEO of ActivBiotics.

Chlamydia pneumoniae infection of the vascular system has long been thought to play a role in acceleratin
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SOURCE ActivBiotics, Inc.
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