ProMetic's Plasminogen Achieves Primary, Secondary Endpoints in Pivotal Phase II/III Trial
ProMetic said its pivotal Phase II/III clinical trial in patients with plasminogen deficiency met its primary and secondary endpoints with the intravenous plasminogen treatment.
ProMetic's plasminogen treatment achieved a 100 percent success rate of its primary end point, a targeted increase in the blood plasma concentration level of plasminogen.
Moreover, all patients who had active visible lesions when enrolled in the trial had complete healing of their lesions within weeks of treatment, a 100 percent response rate for this secondary end point.
The FDA agrees that ProMetic would continue along the accelerated approval pathway and file pharmacokinetic safety data on 10 plasminogen-deficient patients along with efficacy data available for each of these patients that have completed 12 weeks of treatment.