DARRT-2 will involve around 100 patients with progressive, metastatic prostate, breast or lung cancers that have failed standard treatment options and are eligible for low-dose, palliative external beam radiotherapy (RT) to a single lesion.
The clinical-stage drug development company will utilise a higher dose of its Veyonda® drug candidate to generate the phenomenon of the abscopal response in cancer patients.
They will take part In the study across Australia, the US, France and Hungary at around 15 trial sites.
Building on past results
Noxopharm chief medical officer Dr Gisela Mautner said: ”The DARRT-2 study is an important study for us as it builds on the successful results of DARRT-1.
“The difference between the two studies is that DARRT-2 will be a much bigger study and will explore a more intensive treatment with Veyonda®.
“To increase the value of the study, we have added a second trial arm to include a small number of breast and lung cancer patients.
“This will ensure that, apart from the main focus of the study in prostate cancer, we also will generate results in two additional cancer types.”
The abscopal response in cancer patients is a phenomenon where an immune/inflammatory response within a single lesion following low-dose radiotherapy, in turn triggers a whole of body immune response that results in shrinkage of non-irradiated lesions elsewhere in the body.
Noxopharm chief executive officer and managing director Dr Graham Kelly said: “The abscopal response is a highly attractive cancer treatment goal because it provides the opportunity for a major anti-cancer outcome from a generally safe and minimally invasive treatment.
“The challenge is that it is a very rare phenomenon that to date has proven difficult to reproduce on a consistent basis.
“Recent research has pointed to a reason for this being the need to block a certain type of repair process called autophagy of mitochondrial DNA damaged by the radiation.
“Other research points to idronoxil, the active ingredient in Veyonda®, blocking autophagy.
“It is the combination of that effect and the drug’s known immuno-stimulatory effects, together with the earlier DARRT-1 trial data, that provides the confidence that we might have the ability to achieve consistently higher response rates to make DARRT a practical treatment option.”
Veyonda® is an immune-oncology drug that works with the body’s defence mechanisms to fight cancer cells. It moderates and inhibits cancer cell signalling and complements existing therapies like radiation treatment and chemotherapy, enhancing the efficacy of these treatments.