Clinical Trials

The Noxopharm team has extensive clinical trial experience across Australia, the US and Europe, and has conducted multiple clinical trials in leading hospitals across these jurisdictions.  

Noxopharm holds expertise in clinical trial protocol development, the securing of prestigious hospital study sites and investigators, and the implementation and analysis of clinical trials in both oncology and inflammation.

To date, Noxopharm has managed clinical trials in 33 sites globally, and has secured three orphan drug designations (ODDs) in the US and Europe.

Orphan drug status is granted by the US FDA or the European Medicines Agency (EMA) to drugs that show promise in treating less common diseases.

An ODD confers the following benefits:

• Orphan Drug Exclusivity (ODE) provides seven to 10 years of market exclusivity
• Waiver of New Drug Application fees (in the US this was valued at approximately $2.9 million in 2021)
• Opportunities for grant funding
• Regulatory guidance and assistance from the FDA / EMA with the drug development process

IONIC

A Phase-1 investigator initiated study combining Veyonda^® (idronoxil) with the Bristol Myers Squibb checkpoint inhibitor (CI) Opdivo^® (nivolumab) for the treatment of a range of solid tumour types.

The study is intended to explore whether:

• Veyonda combined with Opdivocan stop the development of resistance in cancers already known to respond to checkpoint inhibitors that are becoming resistant during the course of treatment, thereby decreasing the proportion of patients with disease progression
• And, if Veyonda will increase the susceptibility to Opdivo in cancer types that don’t typically respond to this CI.

Checkpoint inhibitors (CI’s) are increasingly being used in cancer treatment. CI’s help the body’s immune cells to recognise cancer cells as foreign and attack these cells, while leaving healthy cells alone.

Current CI’s have been found to be lifesaving for some patients, however, they have applications in just a limited range of cancer types (e.g., melanoma and lung, kidney and bladder cancers). 

It is hypothesised that combining Veyonda with a CI could help to overcome some of the resistance mechanisms of the CI’s and improve the response in patients.

Under the supervision of Professor Paul de Souza, this trial commenced in March 2021 and is ongoing across several Australian sites.