ActivBiotics Announces Expansion Of Phase-3 PROVIDENCE-1 Study Of Antibiotic Treatment Of Patients With Peripheral Arterial Disease During World’s Largest Gathering Of Cardiovascular Disease Researchers

DALLAS, Nov. 14 /PRNewswire/ -- The world’s largest assembly of cardiovascular disease experts serves as the backdrop for today’s announcement that ActivBiotics, Inc., has expanded the list of centers participating in its PROVIDENCE-1 study to include over twenty sites in the United States and Eastern Europe. These hospitals include some of the largest centers treating peripheral arterial disease.

“We are pleased with the number and quality of hospitals that are participating in our study,” said Steve Gilman, PhD, President and CEO. “Having this many centers recruited and involved in the study is an indication of the importance of this disease and the interest in developing new medical therapies for its treatment. Rifalazil is a well-studied drug and may prove to be an important treatment adjunct for these patients, most of whom have few alternatives beyond interventional therapy with surgery, atherectomy or angioplasty.”

The Phase 3 study involves peripheral arterial disease patients with intermittent claudication (lower extremity arterial atherosclerotic disease producing symptoms of buttock and leg discomfort after walking) who demonstrate positive antibody titers to Chlamydia pneumoniae at screening. The primary endpoint of the study involves treadmill measurements assessing peak walking time before and after treatment with rifalazil. The study is expected to enroll 160 patients and is designed as a randomized, double-blind, placebo- controlled study.

About Peripheral Arterial Disease and the Role of Chlamydia - Over 11 million Americans have peripheral arterial disease, the most common symptomatic presentation of which is intermittent claudication, defined as leg or buttock discomfort brought on with walking as a result of the limitation in blood supply to the musculature. Intermittent claudication affects 2.5 million Americans and current medical therapies are not widely used because of side effects and contraindications. Over 30 billion dollars is spent annually in the United States in the overall care and treatment of patients with peripheral arterial disease and the costs of annual care of patients with intermittent claudication is over $9000 per patient. Over 50% of patients with intermittent claudication have antibodies to Chlamydia pneumoniae, indicative of prior exposure to the bacterium. Presence of these antibodies has been correlated with increased progression of peripheral arterial disease and a higher frequency of clinical complications over time. A small trial previously conducted by independent investigators has demonstrated the utility of anti- chlamydial antibiotics in halting the progression of peripheral arterial disease in selective patients.

About the PROVIDENCE-1 Study - PROVIDENCE-1 (Prospective Evaluation of Rifalazil Effect on Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients) is a prospective, randomized, double-blind, placebo-controlled, multi-center study of peripheral arterial disease patients with intermittent claudication, in which assessments of symptoms, prognostic criteria, and functional capabilities will be made over a one year period. If successful, this Company intends to use this trial as a pivotal study in its comprehensive Phase 3 program.

About ActivBiotics - ActivBiotics, Inc. is a private biopharmaceutical company located in Lexington, Massachusetts, that is engaged in developing antibacterial therapies to improve the medical treatment of chronic illnesses with major pharmacoeconomic impact. The Company’s lead drug, rifalazil, has been studied in over 500 volunteers and patients in various Phase 1 and Phase 2 clinical trials. In addition, the Company has a library of over 1500 development candidates in the same antibacterial family as rifalazil, the rifamycin family. Rifamycins are bactericidal and have the ability to effectively penetrate target tissues and cells, making them ideal for use against intracellular pathogens such as Chlamydia. For more information on ActivBiotics, please visit our web site at: http://www.activbiotics.com.

ActivBiotics, Inc.

CONTACT: Media representative Josh Weinstein is on-site at the AmericanHeart Association Annual Scientific Session exhibitors’ newsroom, phone:+1-862-216-5674; Andrew Sternlicht, MD, VP, Medical Affairs and Corp.Development, +1-781-372-4854, asternlicht@activbiotics.com, or Steven C.Gilman, PhD, President and CEO, +1-781-372-4855, sgilman@activbiotics.com,both of ActivBiotics, Inc.

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