Noxopharm (ASX:NOX) has received approval to begin recruitment for the first Phase 1a/1b clinical study of NOX66 from the Georgian Ministry of Health.
NOX66 is an innovative dosage formulation of the experimental anti-cancer drug, idronoxil.
The dosage formulation has been developed specifically to protect idronoxil from being inactivated in the human body by phase 2 metabolism.
This first-in-human formal study will involve patients with late-stage cancer (breast, ovary, prostate, lung, head and neck) who have failed standard therapies.
Importantly, NOX66 is being assessed for its ability to overturn the drug resistance mechanisms developed by cancer cells that enable them to resist all chemotherapy drugs including carboplatin.
Apart from seeking to make carboplatin chemotherapy generally more effective, the ultimate objective is to lower chemotherapies such as carboplatin dosages to safer but highly effective levels.
Noxopharm’s aim is to provide an effective treatment option for patients considered too frail or elderly to undergo chemotherapy, or for patients who chose not to undergo further chemotherapy.
This study is an amended version of the study originally meant to start in late-2016.
The amendment came about because of data suggesting that it was not necessary to test a third, high-dose of NOX66 as originally proposed.
The recruitment for the study is planned for the last week of February following shipment of the drug.
Noxopharm’s share price has increased about 21% since the start of this year, last trading at $0.51.