LEXINGTON, Mass., Nov. 7 /CNW/ -- 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 accelerating the course of vascular disease
potentially by increasing inflammation in the arterial wall thus leading to
exacerbation of atherosclerosis, which could reduce blood supply to target
limbs and organs.
"The conclusive data obtained from this well-powered and well-executed
study provides a compelling argument that C. pneumoniae does not play a role
in PAD that is modifiable by anti-bacterial therapy. Walking impairment in PAD
patients remains a significant unmet medical need, but anti-chlamydial therapy
does not appear to be the solution," Dr. Jaff said.
About ActivBiotics, Inc.
ActivBiotics, Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of therapies for the treatment of
inflammatory diseases and bacterial infections. For more information on
ActivBiotics, Inc., please visit our web site www.activbiotics.com.
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