DMX-200 Phase II Clinical Trials
Our research team is led by clinical investigator Professor David Power and is currently enrolling chronic kidney disease patients (with proteinuria) into a Phase II study in Melbourne, Australia.
Up to thirty patients will be enrolled in the dose escalation study to find the optimum therapeutic dose of DMX-200.
Each patient will be stable on a fixed oral dose of irbesartan and then receive escalating doses of propagermanium every four weeks (30mg, 60mg, 90mg, 150mg, 240mg per day) until the primary safety endpoint is confirmed and improvement in proteinuria is observed, as a secondary endpoint.
The research team expects to carry out an initial interim analysis of the Phase II data to confirm the safety of the therapy and observe any changes. It is anticipated that this interim data will be available by mid-2016.
The dose escalation phase will be followed by an 84-day dose expansion phase using the established optimum dose. This phase will be conducted following consultation with the US Food and Drug Administration (FDA) with the intention of ensuring that future US registration is supported.
Clinical Trial Highlights
– In April we received TGA Special Access Scheme Approval to supply propagermanium to kidney patients after our DMX-200 Phase II trial; giving patients the opportunity to stay on the treatment.
This indicates that the Investigators involved do not have any safety concerns and consider there is potential benefit for patients to continue on the treatment.
– In May we reached our 10 patient milestone and are on track to report interim Phase II Trial Data of DMX-200, confirming we are meeting recruitment targets and timelines.