RE: U.K. investor Mag podcast1 Oct 2023 16:30
@Moneysponge, the 'short' 2 weekly dosing cycle study will still be a Phase 1a (dose escalation) study. The purpose of Phase 1, beyond proving safety and tolerability, is to define the recommended Phase 2 dose (RP2D). For this, Phase 1b (dose expansion) is not absolutely necessary. All that is necessary is to define a workable RP2D (and dosing interval) and the fact that AVA6000 has continued to be given to Phase 1a patients beyond the required 2 cycles means that a lot of dose expansion data will have been collected (for several dose levels) from those patients still being treated.
As an aside for those who think regulatory approval will be granted under Accelerated Approval during Phase 1a (as nth line treatment for heavily pretreated patients 😂), the questions have to be: what RP2D, what dosing cycle and what benefit over 1st line doxorubicin treatment for which STS subtypes?😂
As regards Touk's 1000 patients, very poor attempt at a deramp, the oncology Phases are:
Phase 1: a few patients (10s) to test for safety and tolerabilty (in vitro and animal studies will have already shown it is cytotoxic).
Phase 2: enough patients (low 100s) to decide whether there is efficacy and to gather statistical data on side effects (and their management).
Phase 3: lots of patients (100s to 1000s) to test whether there is an efficacy improvement over the standard of care and to identify rare side effects.
Phase 4: post marketing surveillance to look at long term efficacy and identify very rare side effects.
As AVA6000 is a targetted delivery system for doxorubicin, much of Phases 3 and 4 are irrelevant or could be dealt with under Accelerated Approval by a pivotal registrational Phase 2 study where dosage level and interval are defined for first line treatment of defined indications in doxorubicin naive patients.
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