There are some interesting aspects to IONIC that shareholders might like.
Opdivo is approved by the FDA to be dosed either every 2 weeks (240 mg) or every 4 weeks (480 mg), with no apparent difference in efficacy at either dose. If patients require frequent clinical support, it appears that the 2-weekly dose is preferred.
Because IONIC is a clinical trial, and all patients in Cohort 1 will have just failed Opdivo, I expect IONIC patients in Cohort 1 to be treated every 2 weeks with Opdivo so that they can be have maximum clinical support. It makes sense to use the same treatment regime with Cohort 2, which consists of patients with cancers that until now have been unsuitable for Opdivo.
If Opdivo treatment is 240 mg every 2 weeks, it is almost certain that NOX66 will be administered for 7 days on followed by 7 days off. Dosage levels of NOX66 will probably start at 1200 mg, which has already proven safe, and increase in steps.
For the first time, this would result in administration of NOX66 every 2 weeks at high dose levels. The first week will probably be NOX66 alone, to confirm safety, but after that Trial Investigators will be able to monitor the progress of combination treatment every two weeks.
Interesting times.
The IONIC trial has started to screen patients
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