NUVELO ANNOUNCES PUBLICATION OF ALFIMEPRASE TRIAL RESULTS
Nuvelo has announced the publication of clinical data from the Phase I trial of its lead product candidate, alfimeprase, in the August issue of the Journal of Vascular and Interventional Radiology.
The study of patients with chronic peripheral arterial occlusion (PAO) showed that alfimeprase was generally well-tolerated with no bleeding complications.
The Phase I multicenter, open-label, dose-escalating study evaluated the safety and pharmacokinetic profile of alfimeprase in patients with chronic lower extremity PAO. Each of the study's 20 patients was given one of five escalating doses of intra-arterial alfimeprase. Results showed that no drug-related serious adverse events were observed. Plasminogen and fibrinogen levels remained unchanged, further evidence that alfimeprase acts directly, independent of the plasminogen-plasmin system.
There was a dose-dependent consumption of alpha-2 macroglobulin, the protein that rapidly inactivates alfimeprase once it enters the systemic circulation. Alpha-2 macroglobulin levels returned to baseline within 14 days of receiving drug. In addition, no anti-alfimeprase antibodies were detected within three months after drug exposure. Since this Phase I study was conducted in chronic PAO patients, thrombolytic efficacy was not an objective of the study, however, lysis of blood clots and restoration of blood flow were observed in 40 percent of cases.