Noxopharm Limited announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval to the DARRT-2 study, allowing the study to start in the U.S. DARRT-2 is a multi-national clinical study being conducted in up to 15 sites across Australia, France, Hungary and the U.S. DARRT combines 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 rationale is that low-dose EBRT activates a local immune/inflammatory 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. 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.