RE: RNS for val401 peer review surely10 Jan 2019 07:49
It seems the peer review is saying we need more ph 2 trials and possibly dose escalation studies and is not ready to move on to ph 3 yet.
"Subsequent studies to explore the pharmacokinetics after multiple and difering doses of VAL401 would provide further information, although it should be noted that both the parent risperidone and metabolite 9-hydroxyrisperidone
should be analysed throughout. Further analyses were not possible during this study due to the ethical limitations of
performing multiple blood draws from end-stage cancer patients.
The absolute Cmax value for the active moiety supports our supposition that 2 mg daily dosage would be sufcient
to assess the potential anticancer activity of VAL401, as this would allow the desired level of 20 ng/mL (as tested in the previously reported in vitro model system [9]) to be attained."