The first radiotherapy trial using NOX66 is recruiting patients. Noxopharm has no control over this investigator-initiated trial, but must surely be relieved to see that RNSH has finally achieved clearance from the TGA to proceed. See: https://clinicaltrials.gov/ct2/show/NCT03041285?term=idronoxil&rank=1
In essence, patients receive low dose palliative radiotherapy directed at one or two lesions on days 1-5, then have a week of rest. On day 14 they start taking NOX66 suppositories for two weeks; and on days 15-19 they again receive palliative radiation, this time on lesions that were not irradiated in the first week. The first group of 6 patients take one 400 mg suppository a day; the second group of 6 patients take two suppositories per day but do not start until the first group have safely used NOX66. PSMA-PET CT scans will be done before and three months after treatment.
The initial irradiation of one or two lesions will presumably tell whether radiotherapy-alone at a low dose has any effect on those lesions. The second part of treatment holds the key to this trial.
Patients will have low-dose irradiation of up to three remaining lesions on days 15-19, with NOX66 starting one day earlier and ending one week later. Starting NOX66 treatment on day 14 appears designed to allow it to circulate throughout the body and weaken cancer cells before radiation starts; while the continuation of NOX66 for one week after radiation is designed to prevent cancer calls repairing DNA damage after radiation.
Graham Kelly was treated in a similar fashion and is now free of cancer. This will be our first chance to see whether his experience can be replicated in a clinical trial.
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