- Argenica Therapeutics (AGN) reports no initial safety issues in the sentinel group of subjects for the third cohort of its ARG-007 brain tissue treatment trial
- Argenica can now progress to dosing the rest of the cohort in the trial, which is being conducted in Perth, Western Australia
- The company is testing the safety and tolerability of the drug, incrementally increasing the dose across four groups of adult volunteers
- Data from the third cohort will be presented to a Safety Review Committee, which will determine if Argenica can progress to the fourth and final round of dosing
- AGN shares are up 7.4 per cent and trading at 58 cents at 3:10 pm AEDT
Biotech Argenica Therapeutics (AGN) has reported no initial safety issues in the sentinel group subject for the third cohort of its ARG-007 brain tissue treatment trial.
This means the company can start dosing the rest of this cohort over the next few days.
This phase one clinical trial, being conducted in Perth, Western Australia, is assessing the safety and tolerability of ARG-007 by incrementally increasing the dose of the drug over four groups of healthy adults. The drug is designed to reduce brain tissue death after strokes.
The first two trial patient groups have so far reported no serious safety issues.
Ahead of dosing the third cohort in the trial, Argenica administered the treatment to one sentinel volunteer, at least 24 hours before the other subjects, to identify any serious safety issues.
Argenica CEO and Managing Director Liz Dallimore said safe dosing of the sentinel subject was “good news”.
“The data from these first two cohorts, as well as the 24-hour sentinel data
from the third cohort, gives us the confidence to look forward to our phase two trial in stroke patients,” Dr Dallimore said.
“This is a really exciting stage for the company, and we look forward to continuing to
progress the clinical development of ARG-007.”
Once all dosing is complete, the data from this third group will be presented to a Safety Review Committee, which will determine whether Argenica can progress to the dosing of the fourth and final group of subjects, before the company begins the second phase of the trial.
AGN shares were up 7.4 per cent and trading at 58 cents at 3:10 pm AEDT.