PAA 2022 , Human Trials , Covid , MND , Oncology , HVTL-1, K9 Phase III, page-50

Might be time for an EGM , Extraordinary General Meeting..

Time to discuss exact Timelines and the year that blew out

23 December 2020 ASX announcement
PharmAust Commences Manufacture of GMP-Grade
Monepantel for Human Clinical Trial
• Monepantel (MPL) to be used in a Phase 1/2 human trial in Motor Neurone Disease
(MND), as well as a human Phase 1/2 cancer trial
• The MND trial, co-funded with FightMND, is scheduled to commence in October 2021
• Subject to regulatory approvals the cancer trial in humans is scheduled to commence in
late CY 2021

• In-house small-scale manufactured MPL demonstrates greater than 2-year shelf-life
23 December 2020 – Perth, Australia: PharmAust Limited (ASXAA) is pleased to announce the
commencement of production of 10kg of GMP-grade monepantel (MPL) for research and development
(R&D) in two Phase 1/2 clinical trials in humans. These are a Phase 1/2 clinical trial examining the
effects of MPL in individuals with motor neurone disease (MND), as well as a Phase 1/2 clinical trial
examining the effects of MPL-tablets in humans with selected cancers. MPL will be manufactured in
collaboration with Syngene International Ltd., an integrated research, development and manufacturing
services company.
As previously announced on 29 October 2018, GMP (Good Manufacturing Practice) is a globally
recognised standard that requires rigorous, controlled and continually documented processes to
provide fully characterised drugs with very high levels of purity for safe and effective use when
administered to patients. This level of manufacture meets standards required for clinical trials in
Australia, the US and Europe.