RE:ProMetic's IND for treatment of hypoplasminogenemia receivesIgnition...lol.
ProMetic's IND for treatment of hypoplasminogenemia receives FDA clearance 11/10/2014 05:27 AM ET
Nov 10, 2014 (MarketLine via COMTEX News Network) -- ProMetic Life Sciences Inc., a biopharmaceutical company, has received the FDA clearance for the investigational new drug, or IND, application of the company's IV plasminogen for the treatment of hypoplasminogenemia, or type I plasminogen deficiency.
When approved, this product will provide replacement therapy for patients with this condition, who suffer from a congenital lack of the normal plasminogen protein and/or its functional activity, and are subject to life-long medical problems which currently have no effective treatment.
The FDA has also accepted that ProMetic's proposed Phase II / III clinical program for the IV Plasminogen provides an adequate surrogate endpoint for licensure using the accelerated approval pathway. 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 FDA's decision and welcome their support to bring an innovative and tangible medical solution for patients affected by this severe condition that has no adequate treatment", declared Mr Pierre Laurin, President and CEO of ProMetic. "Seeing our first PPPS plasma-derived therapeutic enter the clinical trial stages also represents an important milestone achievement for ProMetic as we get ready to proceed with additional plasma-derived products targeting other orphan indications", added Mr Laurin.
The Phase I clinical trial is an open label, single ascending dose study that will investigate the safety, tolerability and pharmacokinetics of ProMetic's plasma purified human plasminogen in 6 patients suffering from hypoplasminogenemia. The Corporation expects enrollment to commence this quarter and to progress to Phase II / III in H1 2015, and to enroll a total of 15 to 18 patients. Under the current program the Corporation expects to be in a position to be ready to file a Biological License Application (BLA) for plasminogen commercialization in Q4 2015.
Dr John Moran, Chief medical Officer of Prometic commented: "This is a significant gain for the patients and their families as it will make available for the first time an effective replacement therapy. We are committed to aggressively progressing our clinical program for the benefit of all stakeholders."
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