­ Argenica Therapeutics Limited announced the approval by the Phase 1 Safety Review Committee (SRC) to progress to the fourth and final escalated
dose cohort. Following an extensive review of data from the third cohort of participants, including blood pressure, vital signs, neurological examinations, haematology, and adverse events, the SRC determined that there were no clinically relevant abnormal results due to administration of
ARG-007, and therefore the trial can progress to the next dose escalated cohort, which is the final cohort in the Phase 1 clinical trial. Of the eight participants dosed (six receiving ARG-007 and two receiving a placebo), no serious adverse events were observed following dosing. Further information on non-serious adverse events has now been provided to Argenica and the SRC by the trial Clinical Research Organisation, Linear Clinical Research (Linear). Two of the participants noted non-serious adverse events that were likely related to the administration of ARG-007. A summary of these
adverse events is outlined below: One participant experience symptomatic postural hypotension, which is light- headedness or dizziness when standing after sitting or lying down with a very brief feeling of faintness. The symptoms resolved rapidly. One participant experienced symptomatic postural hypotension, a headache and nausea, however symptoms resolved rapidly. This participant has experienced similar symptoms previously. As the study is currently blinded it is not known whether these participants received the placebo or ARG-007.