Argenica Therapeutics (AGN) has received approval from the safety review committee (SRC) to progress to the second escalated dose cohort of its ARG-007 stroke treatment drug.
ARG-007, the company’s lead neuroprotective peptide candidate, has been previously proven to improve outcomes in pre-clinical stroke models.
Last week, Argenica reported no serious safety issues after dosing its first cohort of patients in the phase one clinical trial, confirming each of the healthy participants indicated good safety and tolerability of the treatment.
Following an extensive review of data from the first cohort of participants, the SRC determined there was no clinically relevant abnormal results, and therefore the trial can progress to the next dose escalated cohort.
Of the eight participants dosed with six receiving ARG-007 and two receiving a placebo, no serious adverse events were observed following dosing.
However, the company and the SRC have received further information from research organisation, Linear Clinical Research that one participant in the first cohort experienced a headache and dizziness which was “resolved quickly”.
The company said the events were possibly related to the drug administration and Linear confirmed these are common phase one trial participant symptoms, including in placebo groups.
Shares in Argenica were up 2.8 per cent, trading at 55 cents as of 2:26 pm AEDT.
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