Study so far6 Aug 2022 09:28
We are a year now into the phase 1a study with two dose escalations being carried out. The statement from Neil bell on the second was:
"The recommendation from the Safety Data Monitoring Committee to initiate dosing in Cohort 3 with 160mg/m2 of AVA6000 is an endorsement of the emerging safety and tolerability profile in the patients enrolled in this study to date. We look forward to providing additional updates as the dose escalation phase of the trial progresses.”
I would say this alone (although there have heen lots of other positive indicators discussed here) proves that the study is going as planned. Worth remembering what the objectives are with this part of the study
PrimaryObjectives:
•To evaluate the safety and tolerability ofAVA6000.
•To determine the maximum-tolerated dose (MTD) (if one is reached) and/or the Recommended Phase 2 Dose (RP2D) for the dose expansionphase.
Secondary Objectives:
•To characterise the pharmacokinetics (PK) in plasma, urine and tumour of AVA6000, of the preCISION leaving group, and of active metabolites (doxorubicin and doxorubicinol) when given as monotherapy, after a single dose and after multiple dosing.
•To evaluate the initial anti-tumour activity of AVA6000 according to RECIST.1.1 criteria (overall response rate [ORR], duration of response [DoR], disease control rate [DCR] progression free survival [PFS] and overallsurvival).
*** We are fairly certain they have biopsies to help with this objective***
The data from this phase is due late Q3, and it will not only prove ava6k if good it proves the whole of the pre|CISION platform.
The point of this post is to give the uneasy, negative or just nervous posters an opportunity to tell us why with what we know to date that it's not going on track to deliver on these objectives?
I can't see anything that suggests that currently.
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