Phase II/III clinical trial in patients with plasminogen deficiency has met its primary and secondary endpoints with the intravenous plasminogen treatment from ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc.has announced that its pivotal Phase II/III clinical trial in patients with plasminogen deficiency has met its primary and secondary endpoints with the intravenous plasminogen treatment. In addition to being safe, well tolerated and without any drug related serious adverse events, ProMetic�s plasminogen treatment achieved a 100% success rate of its primary end point, namely, a targeted increase in the blood plasma concentration level of plasminogen as a surrogate target. 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% response rate for this secondary end point.

Following the pre-BLA meeting recently held with the FDA, it was agreed that ProMetic would continue along the Accelerated Approval Regulatory Pathway and file the 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.