Navigation Links
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 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 http://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.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... 2017   Spotlight Innovation Inc. (OTCQB: ... in the second quarter of 2017, to launch ... to provide relief from chronic pain, is a ... was developed under a licensing agreement with Dr. ... from snake venom. Additionally, Caretta Therapeutics has signed ...
(Date:1/18/2017)... , Jan 18, 2017 Research and Markets ... Vomiting Drugs Market 2017-2021" report to their offering. ... The global CINV drugs ... 2017-2021. Global Thoracic Surgery Market 2017-2021, has been ... experts. The report covers the market landscape and its growth prospects ...
(Date:1/18/2017)... -- In China , we say Health ... of China,s Healthy Strategy originates. 2016 ... Economic and Social Development of the People,s Republic ... state council of the People,s Republic of China ... development plan, identifying medical devices as one of the main ...
Breaking Medicine Technology:
(Date:1/18/2017)... ... 2017 , ... At Hallmark Nameplate, their commitment to quality is what sets ... ISO 13485. This certification is another way they are making constant strides to provide ... they need. , The ISO 13485 Certification is a major accomplishment for Hallmark Nameplate ...
(Date:1/18/2017)... ... January 18, 2017 , ... Michael ... new website for its Center for Biosimilars, announced Michael J. Hennessy Associates, Inc. ... in the field of biosimilars through thought leader interaction in, live video and ...
(Date:1/18/2017)... (PRWEB) , ... January 18, 2017 , ... ... problems ranging from gum disease to enamel erosion, and those dental problems can ... Department of Public Health, many pregnant women are failing to get the dental ...
(Date:1/17/2017)... ... January 17, 2017 , ... Anesthesia Progress – Everyone ... choose the best drug option for each patient. Dentists have several general anesthesia alternatives ... outcomes. , Researchers from the Tokyo Dental College in Tokyo, Japan wanted to find ...
(Date:1/17/2017)... ... January 17, 2017 , ... For breast cancer clinicians and researchers ... those who desire a more intimate review and analysis of its highlights, a novel ... Bedside—is being offered by Imedex on February 4, 2017 in Chicago. Chaired by Kathy ...
Breaking Medicine News(10 mins):