On 27 September 2017 Noxopharm announced approval of a company-sponsored dose-escalation trial of NOX66 with palliative radiation, targeting prostate cancer in 24 patients. Details of the study were made available on clinicaltrials.gov on 12 October 2017: See https://clinicaltrials.gov/show/NCT03307629.
As originally announced by Noxopharm, 4 patients will each receive either 400mg, 800mg or 1200mg of NOX66 daily, together with low-dose radiation, to at least one lesion (but not all lesions) in order to determine whether there is a direct response to radiated lesions; and an indirect response by non-radiated lesions (an ABSCOPAL effect).
Following a review of accumulated safety and efficacy data for the first 12 patients, a further 12 patients will receive combination treatment at the dose found to be most effective in the first 12 patients.
There is a slight change from the original description on 27 September, and that which was listed on 12 October. It is a significant variation, in my opinion.
Noxopharm stated that "Patients will be scanned at 3 and 6 months to determine the extent of any response in both irradiated and non-irradiated tumours, and the durability of any response". The clinicaltrials.gov entry says "NOX66 [Cohort 4] dose will be either one of 3 doses 400mg, 800mg and 1200 mg based on interim analyses of safety data and tumour response at WEEK 6 of 3 dose cohorts of 12 total patients".
I cannot imagine this is a typo, because the scan at 6 weeks is repeated elsewhere. It means that Noxopharm expects to be able to tell whether a two-week treatment regime of NOX66 plus low dose radiation is having a significant effect on tumour size after just 6 weeks.
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