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news.Faron Pharmaceuticals has recruited its first patient to a phase II clinical trial of its lead drug, Traumakine, in the treatment of organ failure after a ruptured abdominal aorta aneurysm (RAAA).
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The phase II INFORAAA clinical trial will target the second indication for Traumakine.
Traumakine is based on a patent-protected use of interferon beta to prevent leakage of vascular beds in acute lung injuries. The recombinant human IFN beta-1a is the active pharmaceutical ingredient in Traumakine.
Currently, Traumakine (FP-1201-lyo) is being assessed in a European phase III clinical study for the treatment of acute respiratory distress syndrome (ARDS).
The phase II study (EudraCT 014-000899-025) will assess the efficacy and safety of FP-1201-lyo compared against placebo to prevent MOF following open surgery for RAAA.
It is a double-blind, randomised (2:1) and parallel group study with same dosing as in the on-going INTEREST Phase III trial for the treatment of ARDS patients with MOF.
According to the company, the INFORAAA study’s primary end point is to assess mortality after 30 days of the first dose administration. It also has various secondary and explorative end points that are related to the nature of these patients.
The company has started the trial in eight sites of Finland, and plans are underway to expand it to Baltic States and UK.
Faron Pharmaceuticals CEO Markku Jalkanen said: “We believe that Traumakine shows significant efficacy for the recovery of operated RAAA patients.
“Furthermore, there is a possibility that a positive outcome of both the INFORAAA and INTEREST trials could result in the INFORAAA trial fulfilling Phase III trial requirements.
“The clinical data of RAAA patients treated with FP-1201-lyo during the INFORAAA trial could also provide us with valuable information on the recovery of ischemic single organ injuries and planning further trials to treat these injuries.”
Image: Faron has started new study to target the second indication for Traumakine. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.