Rifalazil Trial (PROVIDENCE-1) Fails to Provide Significant Clinical Benefit in Patients With Peripheral Arterial Disease
LEXINGTON, Mass., November 07, 2007 /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 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.
Safe Harbor Statement
This press release may contain or incorporate by reference certain statements that are not historical facts, including statements preceded by, followed by or that include the words "may," "believes," "will", "expects," "anticipates" or the negation thereof, or similar expressions, which constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Reform Act"). All statements that address events, transactions or developments that are expected or anticipated to occur in the future are forward-looking statements within the meaning of the Reform Act. Such forward-looking statements involve risks, uncertainties and other factors that may cause the actual performance or achievements of ActivBiotics, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward- looking statements. For those statements, ActivBiotics, Inc. claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. ActivBiotics, Inc. will not undertake and specifically declines any obligation to publicly release the result of any revisions that may be made to any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
CONTACT: Glenn Kazo, Chief Business Officer, +1-781-372-4864,, or Christina DiCarlo, Manager, CorporateCommunications, +1-781-372-4807, , both ofActivBiotics, Inc. email@example.com firstname.lastname@example.org
Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted: November 2007