LAVAL, QUEBEC, CANADA – August 11, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today that it has 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 Food and Drug Administration (“FDA”).
The FDA has agreed to an accelerated regulatory approval pathway, given the rarity of the condition and the related unmet medical need. To secure an accelerated pathway approval, a drug must treat a serious condition, provide a meaningful advantage over available therapies and demonstrate an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.
“We are very pleased with the timely completion of patients’ enrolment in our pivotal plasminogen phase 2/3 trial”, said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “The achievement of this important milestone allows us to confidently proceed with the last phase of the plasminogen congenital deficiency clinical program as we get ready to start filing the required BLA modules necessary to secure licensure from the FDA”.
Dr John Moran, Chief Medical Officer of ProMetic commented: “The ongoing clinical trial has enabled us to meet the primary end-point of achieving the targeted increase in plasma concentration of plasminogen and to define the optimal treatment regimen. We have also observed major clinical benefit in patients with long-standing lesions related to their plasminogen deficiency. As in the patients who have been treated outside the trial on an emergency basis, both the rapidity and the magnitude of the improvement has been remarkable, knowing that in many cases the lesions have been present for years”.
Read more: http://www.prometic.com/prometic-completes-patients-enrolment-in-pivotal-plasminogen-phase-23-clinical-trial/