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FDA clears ProMetic’s IND for plasminogen to treat hypoplasminogenemia

The US Food and Drug Administration (FDA) has reviewed and cleared the investigational new drug (IND) application for Canada-based ProMetic Life Sciences' IV plasminogen to treat hypoplasminogenemia, or type I plasminogen deficiency.

Following approval, this product will serve as replacement therapy for patients who suffer from a congenital lack of the normal plasminogen protein and/or its functional activity.

The FDA has also accepted that the company’s proposed Phase II / III clinical program for the IV plasminogen provides an adequate surrogate endpoint for licensure using the accelerated approval pathway.

ProMetic president and chief executive officer Pierre Laurin said: "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.

"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," Laurin said.

The open label, single ascending dose Phase I trial will investigate the safety, tolerability and pharmacokinetics of its plasma purified human plasminogen in six patients suffering from hypoplasminogenemia.

The company expects enrollment to start this quarter and progress to Phase II / III in the first half of 2015. A total of 15 to 18 patients are expected to be enrolled.