The Sage Group

THE SAGE GROUP Finds a Significant Number of New Pharmaceuticals in Clinical Trials for Treatment of Peripheral Arterial Disease

ATLANTA, February 13, 2008 — (BUSINESS WIRE — According to a report published by THE SAGE GROUP, research activity has intensified on pharmaceutical treatments for peripheral arterial disease (PAD).

“Our analysis found a significant number of new oral therapies in human clinical trials for PAD,” stated Mary L. Yost, author of the report. “Agents are being investigated for the entire spectrum of disease severity including the debilitating walking symptoms of intermittent claudication (IC), limb-threatening critical limb ischemia (CLI) as well as for prevention of ischemic events,” she continued.

“Large Pharma may be awakening to the PAD market opportunity. This marks an important change from 2002, when we began specializing in lower limb disease,” declared Yost.

“Over the past five years, the expansion of the PAD treatment market has been driven almost entirely by the medical device industry with the introduction of innovative endovascular devices,” she explained. “The notable exceptions include Sanofi-Aventis, Bristol-Myers Squibb and several small biotechnology companies,” observed Yost.

According to the report, gene, protein and cell therapies to induce arteriogenesis (angiogenesis) are the hot new areas of research for both IC and CLI. Arteriogenesis, also known as bio-bypass, is the process in which the body grows collateral vessels to bypass an obstruction.

“Adult stem cell therapy represents the single most actively investigated new therapy for critical limb ischemia,” stated Ms. Yost. “We identified over twenty clinical trials worldwide. The majority of these employ autologous (taken from the patient) bone marrow or peripheral blood cells to stimulate growth of new vessels,” she elaborated.

“Several companies including Aldagen, Aastrom Biosciences and Harvest Technologies have developed promising new technologies to separate, concentrate or expand the number of therapeutic cells,” observed Yost.

According to Ms. Yost, “Pharmaceuticals to prevent ischemic events are another area of intense interest.” Anti-ischemic pharmaceuticals include oral anticoagulants, antiplatelets and new oral heparin formulations. For many of these the initial marketing indication is not specifically PAD, rather it is for prevention of ischemic events related to atrial fibrillation, prevention of venous thromboembolism or acute coronary syndrome.

One of the major challenges in clinical trials for intermittent claudication has been a significant placebo effect. “We were quite surprised at the number and variety of IC therapies that failed to reach efficacy endpoints in late stage trials,” commented Ms. Yost. Nevertheless, new therapies to treat walking symptoms continue to be actively investigated with eleven trials ongoing. Two of these are sponsored by Sanofi Aventis; the rest are sponsored primarily by small biotechnology or pharmaceutical companies.

About Peripheral Arterial Disease:

PAD, also known as peripheral vascular disease (PVD) or peripheral arterial occlusive disease (PAOD), is characterized by a reduction of blood flow to the lower limbs due to atherosclerosis. Atherosclerosis is a disease in which the walls of the arteries thicken and harden as a result of the build-up of fatty deposits (plaque) on their inner lining.
PAD patients are at high risk of ischemic events, primarily heart attack and stroke as well as vascular occlusion.

The most commonly recognized symptom, intermittent claudication (IC), is characterized by pain, cramping or fatigue in the legs when walking, which disappears at rest. Although considered a less severe form of PAD, IC can be a debilitating condition which can interfere with mobility and ability to accomplish the tasks of daily living. Significantly, over a five year period 50% of IC patients will experience a heart attack or stroke and 30% of these events will be fatal.

In the later stages of PAD (critical limb ischemia or CLI) blood flow is so inadequate that ulcerations and gangrene occur. Once PAD has progressed to CLI, the risks of limb loss and mortality increase. At six months approximately 20% of those with CLI will die; another 35% will experience amputation.

Peripheral Arterial Disease: New Pharmaceuticals to Treat Claudication Symptoms, Prevent Ischemic Events and to Induce Angiogenesis

The report focuses on oral therapies to treat peripheral arterial disease (PAD). Pharmaceuticals to treat the spectrum of disease severity include those for the walking symptoms of intermittent claudication (IC), medications to prevent ischemic events, as well as agents to induce angiogenesis and cell therapies to treat IC and critical limb ischemia (CLI).

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THE SAGE GROUP, a research and consulting company, specializes in vascular disease in the lower limbs.

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