Bayer HealthCare (BHC) and Nuvelo Inc. have begun patient enrolment in a second pivotal phase III clinical trial of lead product candidate, alfimeprase, for the treatment of central venous catheter occlusion (CO). Alfimeprase is a novel thrombolytic or blood clot dissolver.
The phase III trial, known as SONOMA-3 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-3), is the second of two overlapping, multi-national trials in the phase III alfimeprase program for CO. This open-label, single-arm trial will evaluate the safety and efficacy of 3 mg of alfimeprase in 800 patients with occluded central venous catheters, states the company release.
In January 2006 Bayer HealthCare AG (BHC) and Nuvelo Inc. entered into a collaboration agreement for the global development and commercialisation of alfimeprase. Under the terms of the agreement, Bayer will commercialise alfimeprase in all territories outside the United States.
"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, vice president of medical sciences for Nuvelo and former principal investigator of the phase II trial.
"We look forward to completing the first trial in this program, SONOMA-2, later this year and expect the phase III 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," he added.
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry.