Biotechnology company Argenica Therapeutics (ASX: AGN) has announced positive findings from an international peer-reviewed study assessing the safety of its lead drug ARG-007 to reduce brain tissue death after stroke.
The study was published in the online Journal of Biochemistry and Biophysics Reports by Argenica chief scientific officer Professor Bruno Meloni, in partnership with research collaborators at the Perron Institute for Neurological and Translational Sciences, the University of Western Australia and the University of South Australia.
The findings indicate that, when used in concentrations from 0.125 microns to 16 microns, novel peptide R18D (ARG-007) will not cause any significant degranulation of ex vivo-derived, in vitro-cultured naïve or immunoglobulin E (IgE)-sensitised human mast cells.
It means the drug is unlikely to induce a mast cell anaphylactoid-mediated (or allergic) reaction if administered to patients.
The study also assessed the impact of R18D on hemolysis, which is the breakdown or destruction of red blood cells.
Similar to other cationic arginine-rich peptides possessing intrinsic neuroprotective properties, R18D was found to induce only low levels of hemolysis and only when exposed to cells without plasma at the highest concentration of 16 microns.
Argenica chief executive officer Dr Liz Dallimore said the findings are a positive step in the development of ARG-007.
“We are delighted that this pre-clinical research into the important safety aspects of this drug has been recognised by [our peers],” she said.
“It is a testament to the scientific rigour employed by Professor Meloni and his team of collaborators.”
Pre-clinical stroke models
ARG-007 has been demonstrated to improve outcomes in pre-clinical stroke models and is in the process of being verified for its safety and toxicity before commencing phase one clinical trials in humans.
Argenica hopes the drug will be administered by first responders to protect brain tissue against damage during a stroke, with further potential to enhance recovery post-stroke.