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

3/16/10

Ischemix is facing the biggest hurdle in its 11-year history. The Maynard, MA-based biotech firm is launching the first human study to test the effectiveness of its drug that’s supposed to protect heart tissue from injuries that often occur when blood flow is restored in cardiac surgeries.

The drug, called CMX-2043, is the only contender the company has that’s ready for clinical trials, says CEO Duffy DuFresne. Without backup clinical candidates, the success of the firm’s Phase IIa trial in treating ischemic-reperfusion injury is hugely important to the future of the company.

Success would be a major leap forward for both Ischemix and the treatment of ischemic-reperfusion injuries, for which there are no FDA-approved therapies despite many previous attempts. The closely held company—funded primarily by its chairman, and its medical director—has enough money to pay for the mid-stage clinical and not much else beyond that, according to DuFresne.

“The good news is that we’ve raised enough money to carry us to the end of this trial,” DuFresne says, “the bad news is that we’re not funded beyond that and additional funding is going to have to be determined by how encouraging our results are.”

The clinical trial is expected enroll 200 to 220 patients, many of whom are undergoing surgeries to unblock their arteries and implant stents to restore blood flow, according to DuFresne. The firm’s drug, which was previously tested for safety in healthy people, will need to prove that it’s both … Next Page »

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