PROMETIC INITIATES ROLLING SUBMISSION OF ITS BIOLOGICS LICENSE APPLICATION (“BLA”) FOR PLASMINOGEN WITH U.S. FDA
' December 19, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMetic” or the “Corporation”) announced today that it has initiated the rolling submission of its Biologics License Application (“BLA”) for plasminogen with the U.S. FDA for treatment of patients with plasminogen congenital deficiency. ProMetic’s plasminogen was granted Orphan Drug and Fast Track Designations by the FDA. The Fast Track designation allows rolling submissions of portions of the regulatory application to be submitted and reviewed by the FDA on an ongoing basis.
“Our plasminogen replacement therapy holds promise for patients with congenital deficiency who now have limited treatment options. We look forward to effectively reaching out to all of the patients and to their healthcare professionals attending to their well-being with this first ever available therapeutic solution” stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “The BLA submission for plasminogen has commenced on schedule, and we are on target for an expected commercial launch of plasminogen in the USA in 2017.”
The BLA will include data from ProMetic's Phase 2/3 clinical trial of plasminogen which met both its primary and secondary endpoints, with both endpoints achieving a 100% success rate. The primary endpoint successfully achieved a targeted increase in the blood plasma concentration level of plasminogen as a surrogate endpoint. Moreover, all patients who had active visible lesions when enrolled in the trial had complete healing of their lesions within weeks of treatment, which achieved a 100% response rate for this secondary endpoint.
Mr. Bruce Pritchard, ProMetic’s Chief Operating Officer, stated: “We are already prepared to accommodate the existing plasminogen product needs of the congenitally deficient patients with our current manufacturing capacity” who added, “We are also prepared for the expected product requirements arising from additional clinical indications treated with plasminogen that will follow the initial commercial launch”.
About Plasminogen
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. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
About Plasminogen Deficiency
The most common condition associated with plasminogen deficiency is ligneous conjunctivitis, which is characterized by thick, woody (ligneous) growths on the conjunctiva of the eye, and if left untreated, can lead to blindness. The growths tend to recur after surgical excision, thereby requiring multiple surgeries.
While ligneous conjunctivitis is the best characterized lesion of plasminogen deficiency, hypoplasminogenemia is a multi-organ disease that can also affect the ears, sinuses, tracheobronchial tree, genitourinary tract, and gingiva. Tracheobronchial lesions including hyper viscous secretions can result in respiratory failure. Hydrocephalus has also been reported in children with severe hypoplasminogenemia, apparently related to the deposition of fibrin in the cerebral ventricular system.'
Jim |
