Researchers launch pivotal alfimeprase trial

Bayer and Nuvelo of San Carlos, CA have launched a closely-watched Phase III trial of alfimeprase, a blood clot dissolver for central venous catheter occlusion. About 800 patients will participate in the study. Bayer agreed to pay a $50 million upfront fee and an additional $385 million in milestones when it licensed the drug last month.

"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 Steven R. Deitcher, M.D., vice president of medical sciences for Nuvelo and former principal investigator of the Phase 2 trial. "We look forward to completing the first trial in this program, SONOMA-2, later this year and expect the Phase 3 trial results to confirm the ability of alfimeprase to restore function to occluded catheters in 15 minutes or less, as demonstrated in our Phase II trial."

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