Nuvelo and Bayer HealthCare have started enrolling patients in the second Phase III trial of a drug to treat "leg attack," caused when a blood clot blocks an artery in the leg. Another Phase III trial of the drug is already underway. Between them, the two tests will enroll 600 patients.
The main goal of both clinical trials is that the patients not need open vascular surgery to clear the blockage within 30 days of treatment with the drug. The trials will also test several secondary goals.
Alfimeprase, an enzyme made by recombinant DNA technology, dissolves fibrin, the protein that binds blood clots together. In other trials, the drug has been shown to dissolve leg clots in four hours.