ProMetic Life Sciences Inc. (PLI) 2016年年度报告「TSX」.pdf

1、2016 Therapeutic Highlights.12016 Operational Highlights .3Message to Shareholders .4MD&A.7Financial statements.39ContentsPrometic Life Sciences Inc.2016 Therapeutic Highlights1Plasma-Derived Therapeutics Highlights:Prometics intravenous Plasminogen was the first PPPSTM generated plasma derived ther

2、apeutic to enter clinical trial stages.In August 2016,the Corporation completed enrolment of the congenital plasminogen deficient patients in its pivotal phase 2/3 clinical trial required for the accelerated regulatory approval pathway with the FDA.In October 2016,it was concluded that the phase 2/3

3、 trial had 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,Prometics plasminogen treatment achieved a 100%success rate of its primary end point,namely,a targeted increase i

4、n 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-Biologics Lic

5、ense Application(“Pre-BLA”)meeting held in October 2016 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 patient

6、s that have completed 12 weeks of treatment.Moreover,it was agreed that Prometic would not have to conduct additional clinical studies to demonstrate the clinical efficacy of its plasminogen,and that it would continue to monitor the patients currently enrolled in the study for an additional 36 weeks