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INFORAAA trial receives recommendation from IDMC
INFORAAA trial receives recommendation from IDMC.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 7197Z Faron Pharmaceuticals Oy 19 December 2017 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nStudy update: Traumakine® Phase II/III INFORAAA trial for Multi-Organ Failure receives recommendation from IDMC\n \nFirst recommendation received from the IDMC to continue study as planned\n \nTURKU - FINLAND, 19 December 2017 - Faron Pharmaceuticals Ltd (\"Faron\") (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has received the first recommendation from the Independent Data Monitoring Committee (IDMC) of the INFORAAA study to continue the trial as planned using Faron's wholly owned lead product, Traumakine®. The study currently has six open sites in Finland, two in Lithuania and one in Estonia. The first sites in the UK will open in the beginning of 2018. The INFORAAA study aims to treat a total of 160 post-operative Ruptured Abdominal Aorta Aneurysm (RAAA) patients and the interim results are expected in H2 2018.\n \nThe Phase II/III INFORAAA clinical trial of Traumakine for the treatment of Multi-Organ Failure (MOF) and mortality prevention in surgically operated RAAA patients is based on a similar treatment regimen to the regimen used in patients in the Company's recently completed Phase III INTEREST trial for Acute Respiratory Distress Syndrome (ARDS). The high mortality rate of RAAA, which accounts for 4-5 deaths per 100,000 population (Karthikesalingam et al., 2014), requires new treatments to prevent post-operative reperfusion injury, the principal cause leading to the death of RAAA patients, who demonstrate a 30-50% mortality rate post-operatively. RAAA accounts for 13-14/100,000 hospital admissions annually (Anjum et al., 2012), and is Faron's second indication for Traumakine in clinical evaluation. \n \nPatients with RAAA frequently experience Systemic Inflammatory Response Syndrome (SIRS), despite successful open surgical repair, which can especially affect the heart, lungs, kidneys, and intestines. The death of approximately 80% of the operated RAAA patients is caused by MOF, similar to patients with Acute Respiratory Distress Syndrome (ARDS). The Directors of Faron consider that data seen to date support the rationale for extending the use of Traumakine in similar conditions to potentially treat single, and multip...