ProMetic Completes First Dosing in Plasminogen Deficiency Patients

In its Phase I clinical trial, ProMetic Life Sciences successfully completed its first round of IV plasminogen dosing in plasminogen deficiency patients, which was found to be safe and very well tolerated with no drug-related adverse events. The company will now proceed with the administration of a higher dose in order to complete the pharmacokinetic profile of the drug before year-end as planned. The clinical program will then cross over to Phase II and III in which plasminogen patients will be administered multiple doses to define the optimal treatment regimen to achieve the primary end point. The U.S. Food and Drug Administration has agreed to an accelerated regulatory approval pathway given the rarity of the condition and the unmet medical need.

Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin, making it vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis. The most common condition associated with plasminogen deficiency is ligneous conjunctivitis, which is characterized by thick, woody growths on the conjunctiva of the eye, and if left untreated can lead to blindness.