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:10/10/2017)... EXTON, Pa. , Oct. 10, 2017   ... leader in innovative solutions for injectable drug administration, today ... of West,s ID Adapter for improving the intradermal administration ... the Fourth Skin Vaccination Summit in May 2017 by ... Team Lead, Polio Department, World Health Organization (WHO), and ...
(Date:10/4/2017)... , Oct. 4, 2017  South Korean-based healthcare ... CPR training aide "cprCUBE" on Kickstarter. The device will ... during cardiac arrests with better efficiency compared to the ... offers real-time feedback on efficacy of the compression for ... campaign has a goal to raise $5,000. ...
(Date:10/2/2017)... Diplomat Pharmacy, Inc. (NYSE: DPLO ... LLC , and named its founder as Diplomat,s chief ... Tennessee , will operate under Diplomat subsidiary ... offerings for health care partners to include IT outsourcing, ... "In an interoperable world, technology delivers comprehensive insight ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... “The Journey: From the Mountains to the Mission Field”: ... souls in the Philippines. “The Journey: From the Mountains to the Mission Field” is ... Bible. She has taught all ages and currently teaches a class of ladies at ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest ... its plans to open a flagship location in Covington, LA at 401 N. U.S. ... Go store next to Office Depot in the Holiday Square shopping center. Its location ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... a leader in post-acute health care, have expanded their existing home health joint ... Health. , AccentCare has been operating a joint venture home health company with ...
(Date:10/12/2017)... D.C. (PRWEB) , ... October 12, 2017 , ... Leading ... their peers in Washington, D.C., for the 49th Congress of the International Society ... ., Vice President of the Center for Cancer and Blood Disorders at ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... $3,296 in property taxes a year. In some states—like New York, New Jersey, ... By contrast, many overseas retirement havens have extremely low property-tax rates, which contributes ...
Breaking Medicine News(10 mins):