Enrollment completed in separate Phase II study in Carotid Atherosclerosis
LEXINGTON, Mass., Oct. 24 /CNW/ -- ActivBiotics, Inc. today announced
that the results of its pivotal clinical trial (PROVIDENCE-1) studying the
effect of rifalazil in the treatment of intermittent claudication associated
with peripheral arterial disease (PAD) will be presented on November 7, 2007
at 11:45 a.m. EST at a late breaker Scientific Session at the American Heart
Association's 2007 annual meeting being held 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, will be presenting.
PROVIDENCE-1 (Prospective Evaluation of Rifalazil Effect on Vascular
Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia
Seropositive Patients) is the first of two planned Phase III clinical trials
to study the ability of rifalazil to improve symptoms in patients suffering
from intermittent claudication, an often debilitating and under diagnosed
manifestation of PAD. The prospective, double-blind, randomized, placebo-
controlled trial evaluated the efficacy and safety of rifalazil in 297
patients from the United States, Russia and Brazil. The FDA has granted
rifalazil Fast Track designation for development in this indication.
In addition to the PROVIDENCE-1 Phase III clinical trial, a Phase II
study to evaluate the effect of rifalazil on the progression of carotid artery
atherosclerosis has completed its target enrollment of 72 patients. The
RESTORE-IT trial (Randomized Evaluation of Short-Term Rifalazil Treatment on
Carotid Atherosclerosis and Intima Media Thickness) is a prospective,
randomized, double-blind, placebo-controlled, multi-center study of patients
with a clinical history of atherosclerosis and image-detectable carotid
disease. This study will use the non-invasive imaging techniques of combined
high-resolution magnetic resonance imaging and ultrasound to assess the degree
of architectural changes in the carotid artery brought about by rifalazil
treatment. The presence and progression of carotid disease are strongly
correlated with an increased incidence of cardiovascular and stroke events.
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.
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 at: http://www.activbiotics.com.
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