RE: New Dox Max Cumulative Dose?25 Jan 2023 08:28
From the RNS:
"On the basis of the very favourable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has recommended continuation to higher dose cohorts with the aim of identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the phase 1b and future studies."
If it were solely up to the SDMC, they would have selected a new dose level when taking the decision to continue Phase 1a. As it was, they "recommended" continuation. I'm sure they'll have decided what options they want for future dosing, e.g. increase by 60 but by 40 is OK. I can only see the delay being because some authority needs to be consulted for approval. For example the Ethics Committee need time to go through the data and no doubt will want classification and more details about certain aspects. That will all take time and is beyond Avacta's control. Or it could possibly be the regulatory authority, the MHRA, even the FDA if doxorubicin-breaking changes are being asked for in studies in the US, need to be consulted or to give permission.