Noxopharm Limited (ASX:NOX) Receives Approval for HERACLES Clinical Trial
Noxopharm Limited (ASX:NOX) has received approval from the Human Research Ethics Committee for its HERACLES clinical trial, marking a significant advancement in its pipeline for chronic inflammatory diseases.
Trial Details
The HERACLES trial is the first-in-human study of SOF-SKN™, a novel drug candidate aimed at treating chronic inflammatory conditions. The study will assess the safety profile of SOF-SKN™ across four different concentrations in Australia, leveraging the country’s expertise in inflammatory disease research and early-phase clinical trials. Additionally, Noxopharm will benefit from federal R&D tax incentives by conducting the trial locally.
Operational Progress
Following the approval, Noxopharm will collaborate with the Doherty Clinical Trials team in Melbourne to expedite the trial’s operational setup. This collaboration includes site initiation, preparation and distribution of SOF-SKN™ batches, and the recruitment and screening of participants. The Doherty team is renowned for its expertise in early-phase studies, particularly in immunology and infectious diseases.
Executive Comments
Noxopharm CEO Dr Gisela Mautner stated, “The granting of ethics approval for the first ever clinical trial from our Sofra™ technology platform is an important milestone. The quick approval is testament to the thorough preparation of the dossier by our team and also a very efficient review process by the committee, for which we are very grateful.
“Our team has rapidly developed this drug, successfully navigated its way through extensive preclinical testing, and prepared a robust data package that has now culminated in the trial. We have a lot of work in front of us, but we have planned everything in great detail and will be able to start the trial very quickly. It’s an exciting time, and we will of course keep shareholders updated as these activities progress.”
Motley Fool contributor Lianne Eastty has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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