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news.Nuvelo and Bayer HealthCare have begun patient enrollment in a second pivotal phase III clinical trial of lead product candidate, alfimeprase, for the treatment of central venous catheter occlusion.
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The trial is the second of two overlapping, multi-national trials in the phase III alfimeprase program for catheter occlusion. The trial will evaluate the safety and efficacy of 3mg of alfimeprase in 800 patients with occluded central venous catheters.
“We believe that alfimeprase has the potential to quickly dissolve clots and rapidly restore the ability to infuse critical therapy such as chemotherapy or antibiotics through once occluded catheters,” said Dr Steven Deitcher, vice president of medical sciences for Nuvelo and former principal investigator of the phase II trial.
Previously announced results from a previous phase II study in 55 patients with occluded central venous catheters demonstrated that alfimeprase restored flow to 40% and 50% of occluded catheters five and 15 minutes after the first dose, respectively. By comparison, CathfloActivase (alteplase) did not restore flow at either time point.