Nuvelo Inc announced positive Phase I results with its lead product candidate, alfimeprase, for the treatment of peripheral arterial occlusion (PAO).
Enrollment in the multi-center, open-label, dose-escalation study to evaluate the safety and pharmacokinetics of alfimeprase, was completed in twenty patients across seven centers in the United States. The results show that alfimeprase was safe and well-tolerated. There were no drug related adverse events.
Based on the positive results from this Phase I trial, Nuvelo plans to rapidly initiate a Phase II trial in acute PAO patients. In addition, Nuvelo filed an investigational new drug (IND) application for a second indication, catheter occlusion. This IND was accepted by the Food and Drug Administration (FDA) and Nuvelo plans to initiate a Phase II program in this indication as well. Both trials are expected to begin enrollment in the first half of this year.
"The Phase I study is an important step in establishing the safety of alfimeprase," stated Dr. Ted W. Love, president and chief executive officer of Nuvelo. "We are extremely pleased with the results and are ready to initiate both of our Phase II programs. In these trials we should begin to see clear patient benefit in the safe and rapid dissolution of clots in both PAO and catheter occlusion and we expect to complete at least one of these Phase II 'proof-of-concept' programs by the end of 2003."
Dr. Kenneth Ouriel, chairman of the department of vascular surgery at the Cleveland Clinic and principal investigator of the Phase I study, and Dr. Timothy Murphy, associate professor of diagnostic imaging at Brown University Medical School, will both discuss alfimeprase at the Society for Interventional Radiology (SIR) Annual Meeting March 27-April 1, 2003. Nuvelo expects to present the clinical trial data in either a journal publication or at a medical conference later this year.