Navigation Links
Rifalazil Trial (PROVIDENCE-1) Fails to Provide Significant Clinical Benefit in Patients With Peripheral Arterial Disease

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 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

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.

SOURCE ActivBiotics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
4. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
5. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
8. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
9. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
10. Iomai Trial Shows 100 Percent Immune Response in Elderly Subjects Vaccinated With Novel Travelers Diarrhea Patch Vaccine
11. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
Post Your Comments:
(Date:11/24/2015)... November 24, 2015 --> ... "Spine Biologics Market by Product Type (Bone Graft, Bine Graft ... and Fusion, Posterior Lumbar Interbody Fusion), End User, and Geography ... market was valued at $1.90 Billion in 2014 and is ... of 4.4% during the forecast period of 2015 to 2020. ...
(Date:11/24/2015)... , Nov. 24, 2015 Avery Biomedical Devices ... pleased to announce the appointment of Anders Jonzon ... Dr. Jonzon is ... at Children,s Hospital, Uppsala University, Uppsala and Children,s Hospital, ... he was a fellow at the Cardiovascular Institute (UCSF). ...
(Date:11/24/2015)... 2015 . ... adds Latest Guidebook for Chinese Medical Device GMP ... in November 2015 to the medical devices market ... at . China ... global economies with a fifth population in the ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 25, 2015 , ... In an ongoing Clinical Study conducted by an independent ... UV Angel is evaluating the efficacy of its product and its disinfection protocol. This ... beds) from May 2014 through October 2015 at a 360-bed, acute-care, academic medical center ...
(Date:11/25/2015)... ... November 25, 2015 , ... "When I underwent breast reconstruction ... incredibly uncomfortable," said an inventor from Bronx, N.Y. "In order to meet my ... RECOVERY BRA for added comfort and support. The bra is easier to put ...
(Date:11/25/2015)... ... ... Since its launch in 2012, the Regenestem brand ( ... to patients with chronic degenerative medical conditions. Now, the U.S. Patent and Trademark ... Organizations are required to hold a registered trademark in order to make licensing ...
(Date:11/24/2015)... ... ... Dr. Todd S. Afferica, a noted general dentist in Norcross, GA ... Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many of his dental procedures. ... traditional cutting tools, such as the scalpel and high-speed drill, which can both cause ...
(Date:11/24/2015)... ... , ... In an article published November 12th by Obesity News ... or are not eligible for bariatric surgery. The article explains that candidates for weight ... 100 pounds overweight, or have a BMI of 35 and over with at least ...
Breaking Medicine News(10 mins):