https://stockhound.com.au/argenicas-milestone-commencing-phase-2-stroke-trial-in-q12024/?wtp=argenica-therapeutics-limited-asx-agn-946206&fbclid=IwAR2WREiYjtovau7svmaNDxHGI6kU3UhGDSPAzLxVBbAPlrwRkf9Nz0O92bMArgenica’s Milestone: Commencing Phase 2 Stroke Trial in Q12024
- December 14, 2023
- Healthcare & Biotech News
- Stock Hound
Key Takeaway: Argenica Therapeutics Limited (ASX: AGN) has made a significant stride in stroke treatment innovation. The company successfully completed the manufacturing of ARG-007, a promising neuroprotective peptide, marking a pivotal moment for its upcoming Phase 2 clinical trial in acute ischaemic stroke patients. This development brings the medical community a step closer to potentially groundbreaking treatment options for stroke victims.
In a landmark update that could reshape stroke treatment paradigms, Argenica Therapeutics Limited has announced the completion of ARG-007 drug substance manufacturing, setting the stage for Phase 2 clinical trials to commence in Q1 CY2024. This achievement is a beacon of hope for acute ischaemic stroke (AIS) patients worldwide, as it brings us closer to understanding and potentially revolutionizing stroke treatment.
The process involved Melbourne-based Auspep Clinical Peptides successfully manufacturing the ARG-007 drug substance. Subsequently, CordenPharma, based in Europe, has taken charge of the final stage – transforming this substance into sterilized vials ready for patient administration under Good Manufacturing Practices (GMP). The completion of the saline placebo vials, a crucial control component in the trial, has also been reported.
Acute ischaemic stroke involves a sudden loss of blood circulation to an area of the brain, resulting in a corresponding loss of neurologic function. This condition demands immediate medical intervention, and Argenica’s ARG-007 could potentially be a game-changer in its treatment.
In a highly coordinated effort, Argenica has been setting up multiple hospital sites across Australia for the Phase 2 clinical trial. With the Royal Melbourne Hospital already approved for patient recruitment and dosing, and several other hospitals in the pipeline, the company is diligently ensuring that all ethical and safety measures are rigorously adhered to.
Dr. Liz Dallimore, Managing Director of Argenica, emphasized the significance of this milestone,“Proving the scale-up manufacturing of the clinical grade ARG-007 drug product is a significant milestone for the Company, and we are delighted manufacturing timelines remain on track. Further, we are pleased with the progress of research governance at each hospital, there is a lot of work going on behind the scenes in the Company to prepare for our upcoming Phase 2 trial. We look forward to keeping shareholders updated as further milestones are achieved.”
The establishment of an independent Data Safety Monitoring Board (DSMB) adds another layer of integrity and safety to the trial. Comprised of independent neurologists and a biostatistician, the DSMB will diligently monitor safety data, providing an essential check and balance throughout the trial’s progression.
The Phase 2 trial, a Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study, isn’t just about establishing the safety of ARG-007. It’s also poised to provide preliminary efficacy data and is crucial for paving the way to a pivotal Phase 3 trial and potential partnerships with global pharmaceutical companies.If successful, ARG-007 could herald a new era in neuroprotective treatments, potentially offering new hope to millions of stroke patients globally.
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