RE: Off to sleep9 May 2018 22:17
So much happening here..
-- Japanese partner Maruishi continued to progress their pivotal Phase III ARDS trial in Japan and has received two IDMC recommendations to continue the trial as planned. Maruishi anticipates completion of recruitment of this 120-patient study in mid 2018.
-- Faron received the first recommendation from the Independent Data Monitoring Committee (IDMC) in the Traumakine Phase II INFORAAA study for the treatment of Multi-Organ Failure (MOF) and mortality prevention of surgically operated Ruptured Abdominal Aorta Aneurysm (RAAA), to continue the trial as planned. Study currently on pause until INTEREST study analysis completes and Japanese Phase III ARDS trial is reported.
-- US Food and Drug Administration (FDA) proposed that Faron proceed directly to BLA submission for Traumakine in the US upon successful completion of the European and Japanese Phase III trials. FDA Fast Track Designation was granted in January. Initiation of a collaboration with Syneos Health for Traumakine - a global biopharmaceutical solutions organization with end-to-end clinical development and commercialization capabilities.
-- Second independent manufacturing facility established for Traumakine.
-- Patent estate for Traumakine strengthened with a formulation patent granted in Finland and filed in the US and PCT for Faron's IV dose form of interferon-beta, in addition to allowed patents in Europe and Japan for the use of certain biomarkers to measure the severity and treatment efficacy of patients with ARDS.
Clevegen(R)
-- Preclinical toxicity studies completed with no sign of serious adverse events indicated.
-- Successful production of technical batches of Clevegen by manufacturing partner Abzena.
-- Agreement signed with the University of Birmingham Medical School, UK, to initiate a liver cancer clinical trial program, focused on the protocol design for a Phase I/II trial, MATINS. Clinical trial application expected to be filed in H2 2018.
-- Filed advice package to the UK Regulatory Agency MHRA on the adaptive protocol design for the MATINS trial to include dose escalation and efficacy measures in four solid tumour cancers (liver, melanoma, pancreas and ovarian).
-- Patent granted by the European Patent Office for the use of Clever-1 antibodies, the mechanism behind Clevegen, for the treatment of cancer.
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