Biotech Values

[DewDiligence]

Infection as a cause of PAD? It may not be crazy, but as far as I know it’s novel…

http://biz.yahoo.com/prnews/051006/nyth028.html?.v=26

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ActivBiotics to Conduct Phase 3 Clinical Trial in Peripheral Arterial Disease


New Clinical Initiative Announced at Adams Harkness Trends in Peripheral Vascular Disease Company Showcase & Panel Discussion

LEXINGTON, Mass., Oct. 6 /PRNewswire/ -- ActivBiotics, Inc., a privately held biopharmaceutical company, today announced plans to pursue clinical development of its lead product, rifalazil, as a novel medical treatment for Peripheral Arterial Disease ("PAD"). PAD, also known as Peripheral Arterial Occlusive Disease and Peripheral Vascular Disease, is a serious complication of atherosclerosis that affects over 11 million Americans and severely limits their ability to carry on normal physical activity. It is well recognized that new therapies are needed to treat this debilitating condition, and the mode of action of rifalazil provides a promising new approach. The 160 patient trial has been named PROVIDENCE-1.

In his comments at the Trends in Peripheral Vascular Disease Company Showcase & Panel Discussion, Andrew Sternlicht, M.D., Vice President of Medical Affairs and Corporate Development at ActivBiotics, stated: "Our clinical development strategy is based on the clear association between vascular disease and evidence of bacterial infection in patients, which we believe can be treated successfully by our novel anti-Chlamydia investigational drug, rifalazil."

Prior antibiotic studies in atherosclerosis focused largely on disease in the coronary arteries and studied the impact of therapy on clinical events, including myocardial infarctions, recurrent angina, hospitalization, stroke and death. ActivBiotics is taking a very different approach by focusing on symptomatic relief in patients with lower extremity PAD, directly related to blood flow, rather than life-threatening events. The clinical and quality of life impact of symptom improvement in these patients is well documented.

"Our double-blind, randomized, placebo controlled trial will evaluate the ability of rifalazil to improve symptoms of PAD by assessing improvements in peak walking time. If successful, we plan to use this study as the first pivotal, registration-supporting trial in a comprehensive Phase 3 program," Sternlicht added.

Steve Gilman, Ph.D., President and CEO of ActivBiotics also commented: "ActivBiotics is committed to optimizing the potential of rifalazil and our pipeline of anti-infective agents in large market indications like peripheral arterial disease as well as other chronic conditions in which bacteria, particularly Chlamydia, may aggravate or incite disease." Most of these indications are not currently treated with antibacterials.
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