Biotech

Argenica Therapeutics publishes scientific paper on ARG-007 ahead of clinical trials

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By Danica Cullinane - 
Argenica Therapeutics ASX AGN Journal of Thrombosis and Thrombolysis stroke peer review

Argenica’s preclinical study of the stability of its lead drug has been published in the Journal of Thrombosis and Thrombolysis.

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Biotechnology company Argenica Therapeutics (ASX: AGN) has announced its chief scientific officer Professor Bruno Meloni has published a peer-reviewed paper on the company’s lead neuroprotective asset, ARG-007.

The paper, entitled Impact of poly-arginine peptides R18D and R18 on alteplase and Tenecteplase thrombolysis in vitro, and neuroprotective stability to proteolysis, is now published in the Journal of Thrombosis and Thrombolysis and confirms the “superior proteolytic stability” of the R18D peptide (ARG-007).

It was based on the findings of a study the company had reported to the ASX last July, which suggested that R18D (ARG-007), when co-administered with the thrombolytic inducing agents alteplase (tPA) and Tenecteplase (TNK), which can degrade peptides, do not degrade ARG-007 nor have a negative impact on ARG-007’s efficacy when used clinically during clot thrombolysis.

Argenica chief executive officer Dr Liz Dallimore said the recognition of the research by the peer-reviewed scientific journal is a “testament to the scientific rigour employed by Professor Meloni and his team of collaborators”.

On the path to clinical trials

Argenica is focused on developing novel therapeutics to reduce brain tissue death after stroke and improve patient outcomes.

Its aim is for its therapeutic to be administered by first responders to protect brain tissue against damage during a stroke, with further potential to enhance recovery once a stroke has taken place.

ARG-007 has previously demonstrated improved 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.

Last month, Argenica moved a step closer to clinical trials with the completion of final good laboratory practice (GLP) genotoxicity studies. According to the company, data from the in vitro studies showed ARG-007 “will not likely pose a genetic or carcinogenic risk” to patients.

In addition, the genotoxicity studies are required for the US Food and Drug Administration’s regulatory approval for ARG-007.

Stroke-induced brain damage

According to research presented in Argenica’s most recent investor presentation, 15 million people around the world have a stroke each year and only 10% will recover almost completely.

This low recovery rate is linked to brain cell damage as the reduction in blood flow leads to 1.9 million brain cells dying per minute and studies show the brain ages 3.6 years every hour that stroke treatment is delayed.

According to Argenica, there are currently no universally available drugs that protect brain cells following stroke.