- Noxopharm (NOX) receives the green light from the US Food and Drug Administration (FDA) to begin its DARRT-2 study
- NOX explained the FDA assigned the study an investigational new drug approval, meaning work can get underway in the US
- The clinical study is being conducted in up to 15 sites across the US, Australia, France, and Hungary involving around 100 patients
- The DARRT-2 study combines NOX’s drug candidate with radiotherapy to test the drug’s efficacy as a companion cancer treatment
- NOX shares are up 1.55 per cent at 65.5 cents each
Noxopharm (NOX) has received the green light from the US Food and Drug Administration (FDA) to begin its DARRT-2 study.
The drug development company announced on Thursday that the FDA had assigned the study an investigational new drug (IND) approval.
The approval would allow NOX to begin the clinical study in the US, with sites selected in Los Angeles and Texas.
The study will also be carried out in Australia, France, and Hungary, with a total of 15 sites to be utilised across the globe.
At the heart of NOX’s DARRT-2 study is the company’s drug candidate Veyonda, which will be combined with radiotherapy to test its efficacy as a companion cancer treatment.
Approximately 100 patients with late-stage cancers that have failed to respond to treatment will take part in NOX’s study.
Noxopharm Chief Medical Officer Gisela Mautner said this was the second FDA approval granted to Veyonda.
“This is the second IND granted by the FDA for Veyonda and is an endorsement of our concept of seeing Veyonda become a companion treatment for other standard cancer treatments,” Dr Mautner said.
“FDA approval for the DARRT-2 study is a major step forward in our endeavour to expand access of American cancer patients to Veyonda.”
Meanwhile, earlier this week, NOX also secured approval for another EU patent allowance for Veyonda.
Company shares ended Thursday’s trading session up 1.55 per cent at 65.5 cents each.