Argenica Therapeutics (AGN) has reported no serious safety issues after dosing its first cohort of patients in a phase one clinical trial of its ARG-007 stroke treatment drug.
The biotech company reported the healthy participants in the phase one trial were all successfully dosed, with each indicating good safety and tolerability of the treatment.
Argenica said it would present follow-up data to the Scientific Review Committee in the coming days to seek approval to progress to the second cohort.
ARG-007, the company’s lead neuroprotective peptide candidate, has been previously proven to improve outcomes in pre-clinical stroke models. It is currently in the process of being verified for safety and toxicity before Argenica commences clinical trials in humans.
Should the committee approve Argenica to progress to the second phase, a sentinel dosing will begin immediately.
The sentinel participant is a single volunteer who will receive the investigational drug at least 24 hours prior to the remaining subjects in the dose cohort.
A second volunteer will receive a placebo injection of saline at the same time as the sentinel subject, with the aim of identifying any unpredicted serious safety issues related to drug dosing in a single subject ahead of exposing a larger group of subjects.
Argenica said its goal is for the drug to be administered by first responders to protect brain tissue against damage during a stroke while offering further potential to enhance recovery once a stroke has taken place.
Argenica Therapeutics is up one per cent and trading at 50.5 cents at 12:54 pm AEDT.
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