Member Info for CTSFO

Timster;

https://en.wikipedia.org/wiki/Luciano_Pavarotti

Looking at the P1aA2 design, Avacta wants this to maximise data prior to P2. Think of it as a brand new drug. If a small study shows safety and suggests improved efficacy, then this is the trial to replicate in the big P2 trial.

If their evidence to date suggests fortnightly dosing will markedly improve efficacy AND massively reduce toxicity, it will get prescribed to more patients than plain doxorubicin is at present. Both as a first treatment and a proposed maintenance therapy. This is huge, and well financially massive. It’s honestly worth the wait. This is more than icing on the cake.

May I suggest this: Avacta has lab based research showing a marked improvement in efficacy with a fortnightly dosing regime? Or their data analysis thus far indicates improved cell death with a fortnightly dosage regime.

P2 will be the licensing trial for AVA6000. It’s honestly best they get this one, the first one, right. Getting approval for a three weekly regimen, then seeking PL alteration for fortnightly dosing will take another expensive, in time and money, trial. Honestly best to get the first P2 to be definitive trial.

Playing Devil’s Advocate, maybe the FDA or ‘interested parties’ suggested the two week trial? Obviously we don’t know all of P1a data, but I’d be surprised if it was enough to go straight to market. A hybrid P2&3, for a designated orphan drug, would make sense. I honestly don’t think they’d be doing the P1aA2 without very good reason. Because of exactly what we all want, P2/3 to get approval and start enrolling.

GLA

Ice, I’m going to respectfully disagree about the two week trial. My reason: plain doxorubicin has had to be given every three weeks because of its side effect profile. The present P1a for AVA6000 has proven its safety in a like for like dosing timescale. But it’s a distinct possibility doxorubicin is more effective if given more frequently. Unfortunately this needs its own P1a safety data to be taken forward. Depending on the P1aA2 (fortnightly) results, the P2 trial for AVA6000 may well be a fortnightly trial. That’s potentially world changing.

GLA.

Thorn, nature and AIM abhor a vacuum! And we’re sure as hell in a vacuum of news at present. It’s so frustrating.

GLA.

Let me clarify:

Reading the posts today has been more depressing than normal. The lack of understanding about the route to market for AVA6000 vs a brand new molecule staggers me. The failure of people to research the Orphan Drugs get trialed. Yes this takes funding, but I honestly think AVA6000 is closer to market than people realise. A combined phase 2&3 trial for STS is relatively quick. The funding can come from a variety of options.

I respect a cautious approach to investing, but a well researched one as well.

GLA.

Couldn’t agree more. Looking at people’s lack of understanding about Pharmacology and Pharmaceuticals makes me feel so sorry for them. In the meantime something is happening in the background. Possibly a placing. Drugs cost money to develop and trial. The only question is how much, and which options will Avacta have to make it happen?

GLA

CLINICAL TRIAL DESIGN FOR ORPHAN DRUGS / RARE DISEASES:

Worth a read. AVA6000 can have a more bespoke trial to get it to market.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7613711/

Reporting of price sensitive information

AIM Rule 11 requires notification without delay of any new developments which are not public knowledge which, if made public, would cause a significant movement in its share price. The Guidance Notes in part 2 of the AIM Rules make clear that this means information a reasonable investor would be likely to use as part of an investment decision. There is an exemption set out in the guidance relating to transactions which are in the course of negotiation where disclosure might prejudice those negotiations, provided that those who are aware of the information (e.g. the other party to a negotiation and professional advisers) keep that information confidential and do not trade in the company’s shares. The Guidance Notes for Rule 11 also allow companies not to notify information about impending developments in certain circumstances, provided that this information is kept confidential. Companies choosing not to make such information public must have effective procedures and controls in place to ensure confidentiality and minimise the risks of a leak.

Ensure confidentiality??!

Same here. Night, sleep well.

GLA

Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7613711/

A useful retrospective analysis of the use of plain doxorubicin against Soft Tissue Sarcoma. Interesting to see the continued use of doxorubicin suggested as a maintenance therapy. At least there is a robust dataset to compare AVA6000 against.

https://clinicalsarcomaresearch.biomedcentral.com/articles/10.1186/s13569-020-00137-5

The 10 points seemed very reasonable to me.

Answering the point about fortnightly dosing,

Agree limited data released so far. I’d like to see the data for each case. Doxorubicin levels in the tumour cells and its FAP status is essential to know.

Fortnightly dosing: my take is the evidence so far suggests this is safe and will improve efficacy. AVA6000 should allow a higher peak and sustained higher intratumour levels of free doxorubicin. Growing evidence it’s not just DNA replication damage that causes tumour cell death. Fingers crossed we see enhanced killing with higher drug levels.

Not sure if a higher dose - peak and total delivered to the tumour - might help reduce Multi Drug Resistance.

Yes. That’s the last reply. ✊🏻

Good advice. I don’t normally filter posts. But when it’s a blatant FUD agenda, pandering to 🍕💩🦷W⚓️’s paymasters, it’s time to ignore them.

Thrushius Vicarius, You’ve reached the bottom of the barrel. I’ve heard some nescient conspiracy theories in my life, but that one is the best.

Why appoint a world renowned scientist as a consultant and not use her front of camera? Why choose a name which means deputy or vice, as in inferior to the full person?

1) Thrush : a bird.

2) Thrush: a fungal infection of, in particular, female genitalia. Causing inflammation and severe irritation.

3) Thush: a highly annoying person, ‘an irritating c@@t’.

Certainly here in force today.