Australian clinical-stage drug development company Noxopharm (ASX:NOX) has announced that the US FDA has granted Investigational New Drug (IND) approval to the DARRT-2 study.
The company said DARRT-2 is a multinational clinical study being conducted in up to 15 sites across Australia, France, Hungary and the US
DARRT combines Noxopharm's Veyonda with low-dose external beam radiotherapy (EBRT) delivered to an isolated tumour to trigger a whole-of-body anti-cancer outcome known as an abscopal response.
The company said the rationale is that low-dose EBRT activates a local immune response within the irradiated tumour that is amplified by Veyonda, converting a local anti-cancer response into a systemic response.
Ethics review currently is underway in Australia. The company said those sites and the timing of patient recruitment are expected to be announced very shortly.
DARRT-2 will involve approximately 100 patients with progressive, metastatic cancers whose cancers have failed standard treatment options and who are eligible for low-dose, palliative external beam radiotherapy. The cancers will be mainly prostate cancer, with a smaller cohort of breast or lung cancer. The international clinical research organisation, Parexel, is facilitating the study.
Dr Gisela Mautner, Noxopharm chief medical officer, 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”.
Dr Chad Tang, assistant professor and radiation oncologist at the MD Anderson Cancer Center, 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.”