The company has high hopes that alfimeprase will work more quickly and with fewer side effects than current industry standards, known as plasminogen activators, which can take several hours or even days to work and can cause significant side effects including bleeding and intracerebral hemorrhage.
The phase I 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 the drug. Results showed that no drug-related serious adverse events were observed, and although efficacy was not an objective of the study, breakdown of blood clots and restoration of blood flow were observed in 40% of cases.
“The safety findings in this phase I trial have since been confirmed in a phase II study, and our phase III program is now underway to evaluate the efficacy of alfimeprase in patients with acute PAO,” said Dr Michael Levy, senior vice president, R&D for Nuvelo. “Clinical trials to date have demonstrated that alfimeprase is well tolerated and has shown potential as a rapid-acting clot dissolver with a favorable safety profile and attractive dosing schedule.”
PAO affects more than 100,000 people in the US per year, it is the result of underlying peripheral arterial disease, in which chronic fatty plaque buildup restricts blood flow and is then complicated by the formation of an acute clot. If blood flow is not restored quickly, leg attack can lead to permanent nerve and muscle damage, gangrene, and in the most severe cases, amputation and death.