Argenica Therapeutics Limited announced that the first subjects in the third cohort of its Phase 1 clinical trial of ARG-007 have been dosed. The subjects in the third cohort will receive a higher dose of ARG-007 than the second cohort. Importantly, the dosed subjects in the sentinel group showed no serious safety issues 24 hours after dosing and therefore dosing of the remaining participants in cohort three will now be completed over the next few days.

Following the dosing of these participants, all follow up data will be presented to the Safety Review Committee who will then confirm the progress of the trial to the fourth and final cohort. CLINICAL TRIAL UPDATE FROM FIRST TWO COHORTS: The Company is pleased to advise that data analysed from the first two cohorts of participants in the Phase 1 clinical trial showed no clinically relevant changes across all assessments performed in both Cohorts 1 and 2. Of the possibly related AEs previously announced the safety review committee determined that they were not clinically significant and therefore the doses of ARG-007 appeared to be safe and well tolerated, and dose escalation could proceed. The Phase 1 clinical trial, conducted at Linear Clinical Research facility in Perth, Western Australia, is designed to assess the safety and tolerability of ARG-007 across four cohorts of healthy adult volunteers, with each cohort receiving an ascending dose of ARG-007.

The first volunteer dosed in each cohort is a sentinel subject, meaning this single volunteer receives the investigational drug at least 24 hours prior to the remaining subjects in the dose cohort. A second volunteer receives a placebo injection of saline at the same time as the sentinel subject. The intention of the sentinel is to identify any unpredicted serious safety issues related to drug dosing in a single subject prior to exposing a larger group of subjects.