Noxopharm Announces Commencement of DARRT-1 Clinical Study

Noxopharm announced that the first cohort of 4 patients has commenced treatment in the Company’s key DARRT-1 clinical study.

The DARRT-1 study is being conducted at 11 centres in Australia, New Zealand and Georgia. It involves men with late-stage prostate cancer (metastatic, castrateresistant disease) receiving NOX66 in combination with a palliative (low) dose of radiotherapy. The first four patients have been recruited in Australia (1) and Georgia (3).

Patients with late-stage prostate cancer that have failed to respond to standard therapiestypically have multiple secondary tumours in their skeleton and soft tissues such as lymph nodes. Radiotherapy often is used in an attempt to achieve relief from symptoms such as pain or spinal compression by irradiating a small number (1-3) of the largest tumours. Such treatment is referred to as palliative treatment because it is intended to provide symptomatic relief and not to be curative.

The rationale behind the DARRT-1 study, and the development of NOX66 in combination with radiotherapy, is that NOX66 potentially will enhance the anticancer effect of the radiation in two ways: first, that those tumours exposed to direct radiation will respond better and for longer; second, that all remaining tumours not exposed to radiation also will shrink (so-called abscopal response). The abscopal response is a rare phenomenon and would not be expected in these patients.

DARRT-1 involves exposing between 1 and 3 individual tumours to external beam radiotherapy, daily for 5 days. NOX66 is given daily for up to 15 days. The treatment is completed within 2 weeks; tumour response is assessed by scans after 6, 12 and 24 weeks. Side effects of treatment will be monitored throughout.

The study involves 24 men divided into 4 cohorts. The protocol calls for the first cohort of 4 men to undergo treatment with the lowest daily dosage (400 mg) of NOX66 as a safety review. If that treatment is well tolerated, as the Company anticipates, then the study will recruit a further 4 patients to receive 800 mg NOX66 (Cohort 2) , followed by a further patients to receive 1200 mg NOX66 (Cohort 3). The dose for the remaining 12 patients (Cohort 4) will be decided based on the review of the first 12 patients after all have been assessed at 6 weeks. It is anticipated that this milestone will be met in July 2018, with the remaining patients recruited into the study by August 2018.


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