Nuvelo Inc announced successful completion of a planned interim analysis of its Phase II trial with lead product candidate, alfimeprase, for the potential treatment of acute peripheral arterial occlusion (PAO).
The interim analysis was conducted on data from the first 36 patients enrolled in the trial. Following review of the patient data, the Data Safety and Monitoring Board (DSMB) and the Trial Steering Committee have recommended that the company continue to move forward with the trial in all three doses of alfimeprase, 0.1 mg/kg, 0.3 mg/kg and 0.6 mg/kg.
"I am encouraged by the decision of the DSMB," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "This preliminary data suggests that all three doses are worthy of further investigation."
Phase I data on alfimeprase will be featured in a scientific session presented at the upcoming AIM (Advanced Interventional Management) Symposium, November 18, 2003 in New York City. The presentation will be given by one of Nuvelo's principal investigators, Dr. Jacob Cynamon, entitled, 'Alfimeprase: A Novel New Thrombolytic Agent That May Reduce Complications And Improve Efficacy.'
The multi-center, open-label, dose-escalation study evaluating the safety and efficacy of alfimeprase in acute PAO patients is being led by Dr. Kenneth Ouriel, chairman of the department of vascular surgery at the Cleveland Clinic, and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center. The study is comparing three different doses of alfimeprase, in over 100 patients across twenty centers in the United States, Europe and South Africa.
Nuvelo is also currently conducting a Phase II trial to evaluate the safety and efficacy of alfimeprase in a second indication, catheter occlusion. This multi-center, randomized, double-blind study began in June 2003 and is comparing three doses of alfimeprase against the approved dose of t-PA (alteplase). Dr. Steven Deitcher, head of hematology and coagulation medicine at the Cleveland Clinic, is the principal investigator of the study that is being conducted in approximately 100 patients across twenty centers in the United States.