Business
Faron update for 2017
Faron update for 2017.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 3869W Faron Pharmaceuticals Oy 09 February 2017 \n \n\n \nFaron Pharmaceuticals Oy\n(\"Faron\" or the \"Company\")\n \nFaron update for 2017\n \n \n \nTURKU - FINLAND, 09 February 2017 - Faron Pharmaceuticals Ltd (\"Faron\") (LON: FARN), the clinical stage biopharmaceutical company, is pleased to provide the following update for the year ahead, 2017. The Company's full year 2016 audited financial results will be announced on 29 March 2017.\n \nTargeted pipeline progress for 2017:\nTraumakine®:\n· The Company expects to obtain the read-out for the pan-European phase III trial (INTEREST) results (all-cause mortality at day 28) during H2 2017. \n· The Company has recently received the third recommendation from the trial IDMC (Independent Data Monitoring Committee) to continue the study without any modifications.\n· The Company has established a manufacturing plan to build its stocks of Traumakine®. Subject to a positive outcome of the INTEREST study, having manufacturing in place should facilitate the application process for market approval of Traumakine®. \n· The Company plans to commence a Phase II US safety study (INTRUST) with Traumakine® in H2 2017. It is expected that the full study will take 12 months to complete. Timing remains subject to regulatory approvals with a pre-IND FDA meeting targeted to occur in Q3 2017.\n· The Company currently expects the Japanese Phase III pivotal study recruitment for the treatment of ARDS with Traumakine®, run by its Japanese licensing partner Maruishi Pharmaceutical Co., to progress towards completion during 2017.\n· The first recruited patient for the Company's Traumakine® clinical study (INFORAAA) for the treatment of patients with rupture of acute abdominal aorta (RAAA) is expected in Q1 2017. The Company expects to get interim results from this 160-patient trial in 12 to 18 months. The aim of this trial is to reduce mortality in operated RAAA patients, which normally varies from 30 to 50% of all patients surgically operated on. The INFORAAA study will also assist in the design of Traumakine® trials for single organ failures.\n\n \nClevegen®:\n· &n...