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Ischemix Faces Moment of Truth with Mid-Stage Heart Drug Trial

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safe and effective for patients to succeed in the trial. (To date, the effectiveness of the drug has only been shown in rodents.) The CEO says the results should be in by the end of 2010.

Heart surgeries can actually result in more tissue damage. This is because of the body’s natural response when blood flow is restored to oxygen-starved cells after a blockage is removed. Restoring blood flow all at once unleashes reactive oxygen molecules that can damage heart tissue. Such ischemic-reperfusion injuries are a major cause of heart damage and deaths after surgeries, DuFresne says. (Yet exact statistics on such injuries are hard to come by.)

The biggest need for Ischemix’s drug is in coronary artery bypass surgeries, of which there are about half a million done in the U.S. every year. However, the health status of patients who receive these bypass procedures can vary considerably, DuFresne says, so the company’s latest clinical trial will include patients undergoing catheter-based cardiac surgeries such as angioplasties, whose conditions are more uniform. If the clinical trial shows that the drug is effective, the plan is to later test the treatment in patients undergoing the bypass surgeries.

While there are no approved treatments for ischemic-reperfusion injuries, DuFresne says, heart surgeons typically use blood-thinners during procedures to prevent clotting in arteries. But those treatments don’t address reperfusion injuries. On the other hand, Ischemix’s lead drug … Next Page »

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