The decision (last year?) to prioritise sarcoma over DARRT was a strategic mistake, in my opinion, and it looks like Noxopharm agrees. DARRT-2 is again the clear priority, as it provides the most assured path to FDA approval.
DARRT-2 as we know will be an adaptive Phase II/III trial.
Oncology and radiation experts from major treatment centres in the USA were so excited by DARRT-1 results that they recommended Noxopharm bypass the typical Phase II trial.
A Phase II/III adaptive trial will have a randomised Control Arm which gets one session of palliative radiation alone, plus inert suppositories
The Treatment Arm will get one session of palliative radiation PLUS up to six sessions of NOX66
Neither the Control nor Treatment arms will receive radiation after the initial 5-day session
Once patients suffer disease progression they are immediately withdrawn from the trial for statistical purposes, but it looks like they will be given the option to switch to radiation plus NOX66
The trial design should be attractive to both physicians and patients.
No time has been lost, as the preparatory work for the Sarcoma IND application can be used for the DARRT application
NOX started with a single 2-week session of NOX66 because hospital committees first needed to be convinced that NOX66 was safe to use. Now that safety has been established, additional session of NOX66 monotherapy will easily gain approval.
This is a key development, in my opinion. A terminally-ill patient might be reluctant to sign up for a one-off treatment that takes just two weeks, but the addition of up to six sessions of NOX66 will surely provide a psychological boost for the patient and his physician, and there is a reasonable hope that these sessions will boost the initial immune response. I like it.
NOX Price at posting:
35.5¢ Sentiment: None Disclosure: Held
