The RNSH trial is an Investigator-controlled trial. Noxopharm has no control at all.
Clinicaltrials.gov shows that the initial protocol involved radiation alone, followed after 13 days by radiation plus NOX66, in a (presumed) attempt to establish whether any abscopal responses might have been caused by radiation alone. RNSH would now know that abscopal responses can take six weeks to become evident, so initial treatment with radiation alone would be a waste of time and potentially harmful to the patient.
The other change that caught my eye was a reduction in the radiation dose from 25 Gray to 20 Gray, which suggests that NOX results have convinced RNSH that abscopal responses are possible with ultra-low radiation doses that can be directed close to vital organs.
The RNSH trial partially duplicates the NOX trial, but my guess is that it is intended as a proof-of-concept trial that would justify expansion to other forms of cancer. For instance, if there were no safety issues, clinicians might ask patients who were about to receive palliative radiation whether they would like to take NOX66 as well.
Thanks for bringing this to out attention, Harvett, even though you own no shares.
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