Noxopharm Ltd (ASX:NOX) has secured Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its DARRT-2 multi-national clinical study, paving the way for the trial to kick off in the United States.
The green light marks the second IND classification granted to cover the administration of Noxopharm’s anti-cancer drug candidate, Veyonda®, in US cancer patients.
So far, two prominent US cancer centres have volunteered to participate in the DARRT-2 study, which will take place over as many as 15 trial sites across Australia, France, Hungary and the United States and involve around 100 patients.
Specifically, the US’ largest and top-ranked comprehensive oncology institution, the Texas-based MD Anderson Cancer Center, and Los Angeles’ Beverly Hills Cancer Center sought to participate in the clinical trial and will serve as the study’s US sites.
“A major step forward”
Noxopharm chief medical officer (CMO) Dr Gisela Mautner said:” 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.
“FDA approval for the DARRT-2 study is a major step forward in our endeavour to expand access of American cancer patients to Veyonda.
“The interest of the MD Anderson Cancer Center, one of the top cancer centres in the US, is something we are very proud of. This will give our study a huge boost.
“Clearly, these achievements demonstrate that we have an excellent team in place that is highly competent and motivated to deliver results for patients, and for the company”.
MD Anderson Cancer Center assistant professor and radiation oncologist Dr Chad Tang echoed the CMO’s comments and said: “I am very excited to be the lead investigator at MD Anderson for this interesting trial.
"It will be an important study for patients with metastatic cancer who require low-dose radiation therapy.”
The DARRT-2 study
Noxopharm’s upcoming DARRT-2 trial 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.
Abscopal response is when 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.
Speaking to the phenomenon in an ASX announcement on the DARRT-2 study last month, Noxopharm CEO 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.”
An ethics review into the DARRT-2 study is currently underway in Australia, with Noxopharm expected to announce the sites and timing of patient recruitment for the trial down under very shortly.
International clinical research organisation Parexel will facilitate the study.