Australia-based Noxopharm has initiated a Phase Ib clinical trial of NOX66 in metastatic castrate-resistant prostate cancer patients who do not have remaining standard therapeutic options.
NOX66 is being developed for sensitising the cancer cells to radiation to an extent that will allow even a low radiotherapy dose to achieve improved tumour responses and patient survival.
The firm intends to study the ability of the radio-sensitiser to elicit more potent responses in direct radiation exposed-tumours and in other tumours that did not undergo exposure.
Planned to be conducted at five radiation oncology clinics in Queensland and New South Wales, the Phase Ib trial will enrol 24 subjects with multiple tumours.
Some tumours will be radiated with normal dose intended to obtain only partial shrinkage for short-term symptomatic relief of pain, while others will not be radiated, purposefully, to assess their response to treatment.
Patients will be administered with 400mg, 800mg or 1200mg NOX66 daily for around two weeks from the time of the radiotherapy, which will be carried out over a duration of seven days.
Noxopharm CEO Dr Graham Kelly said: "The first question we are asking in this study is whether NOX66 can make those tumours exposed to radiotherapy go from a typical partial response of short-term shrinkage, to a more significant response involving longer-term complete remission.”
It is expected that treatment in the trial will commence next month and the enrolment of initial 12 subjects will be completed by December this year.
The remaining 12 patients will be recruited by the end of the first quarter of next year, after a safety review is performed.
Safety of the combined treatment is a primary objective of the trial, and patients will be scanned at three and six months to investigate the durability of response and its extent in irradiated and non-irradiated tumours.