RE: Quote from ALLEGED TG meeting with Avacta.30 Oct 2023 17:26
There a few reasons why Avacta release data prior to the conclusion of the 1a trial.
If one thinks that the FDA and MHRA required a full data disclosure of C1-C4 (an end of term report, if you like) for approval to continue up to C7 and 400mg/mΒ², then the same would surely be the case for a continuation of Phase 1a as fortnightly dosing.
Also, as there have been patients responding clinically in this safety and tolerability study, then now, after C6, might be a good time to publicise the trial, particularly if a case study could be included.
Another reason might be to provide tasty data morsels to the many pharma companies showing interest but needing convincing with hard, verified data.
I've got to say that no one should now be surprised to see tumour shrinkage after administration of AVA6000 as it was known that doxorubicin has been shown to be present in tumours at therapeutic levels and it is known that doxorubicin shrinks tumours - it is used in some treatments as a neoadjuvant therapy before the main treatment (surgery, radiotherapy or other chemo), an example being in breast cancer before surgery. What may be surprising is shrinkage of tumours that doxorubicin hasn't been seen to shrink before or continuing shrinkage after the time that doxorubicin resistance might be expected to kick in. We, here, haven't been given the information needed to determine whether these are the case.