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@Dollyg, and anyone else, have a listen to this podcast interview with Avatca CEO Christina Coughlin:

https://www.youtube.com/watch?v=HWkh3OEFSds&t=1333s

The hypothesis explaining why faridox does not have the cardiotoxicity of straight doxorubicin was given last year:

"FIGURE 10. The First Pass Effect of AVA6000 Versus Conventional Doxorubicin Leads to Different Tissue Distribution

• The lower organ extraction [chemotherapy-induced organ toxicity] of doxorubicin observed with the PDC (AVA6000) compared to direct administration can be explained by its tumor-activated mechanism of action.

• Following AVA6000 dosing, doxorubicin is enzymatically released in the tumor microenvironment, and only a fraction of the active drug subsequently enters the systemic circulation, reaching other organs—including the heart—at delayed and lower concentrations.

• In contrast, conventional intravenous administration delivers high concentrations of doxorubicin systemically from the outset, resulting in immediate exposure of the heart."

From poster 'Comparative Pharmacokinetics and Tumor Activation of Fibroblast Activation Protein (FAP)-enabled pre|CISION® Peptide Drug Conjugates' presented at AACR 2025, April 2025, Chicago. The poster includes with some nice descriptive images.

https://avacta.com/wp-content/uploads/2025/04/Abstract-CT15.pdf

In other words Bella, do we now have a Phase 1/2 trial with the possibility of becoming effectively a registrational trial for SGC [no chemo SoC] and STS [doxorubicin SoC]? Would likely need more patients to prove statistical significance and still need a confirmatory Phase 3 of course.

Fed up with seeing Avacta described as being based in Wetherby, I sent an email...

https://www.lse.co.uk/news/AVCT/correct-avacta-reports-progress-in-faridoxorubicin-clinical-programme-2zvaz513gqisvyz.html

Safety - ✔️ sorted

Tolerbility - ✔️ sorted

Efficacy - ❔ well, when in place, doxorubicin will do what doxorubicin does but no one has ever before been able to discover just exactly what doxorubicin can do when delivered to the tumour microenvironment in very high concentration, multiple times, and for a great length of time because longterm use has been curtailed up to now by its cardiotoxicity. That changed today. We shall now see in due course how much of a cancer controller or killer doxorubicin is, but for me AVA6000 it's looking like a definite ✔️ sorted

Two storey high piles of bagels for sure!

The following have been the changes to the eligibility part of the trial protocol between 12 Decemner 2024 and 11 December 2025.

https://clinicaltrials.gov/study/NCT04969835?tab=history&a=8&b=11#version-content-panel

*SGC*

Original: 0 or 1 prior lines of therapy in the locally advanced or metastatic setting.

Became: 0 or 2 prior lines of therapy in the locally advanced or metastatic setting.

- - -

Original: Adenoid cystic carcinoma subtype to be capped at 15 patients (assuming cohort of approximately 30 patients).

Became: Adenoid cystic carcinoma subtype may be capped at 15 patients (assuming cohort of approximately 30 patients).

- - - - - - - - -

*TNBC*

Original: Up to 2 lines of prior therapy in the locally advanced or metastatic setting.

Became: Any prior therapy in the locally advanced or metastatic setting.

- - -

Original: BRCA with PD-L1 negative.

Became: Patients must be BRCA wild type.

- - - - - - - - -

*Additionally*

Original: Patients must not have previously received an anthracycline-based therapy.

Became: Patients with high grade soft tissue sarcoma or salivary gland cancer must not have previously received an anthracycline-based therapy.

New: Patients with TNBC may receive up to 250mg/m2 of prior doxorubicin (or an equivalent anthracycline). Prior anthracycline based therapy must have been completed at least 6 months before the planned Cycle 1 Day 1 AVA6000 infusion. Prior anthracycline use must have been in the adjuvant or neoadjuvant setting only.

- - - - - - - - -

Here is the link to see the changes announced today. As the US is in another government shutdown, this link will become active only when the clinicaltrials.gov database has been updated.

https://clinicaltrials.gov/study/NCT04969835?tab=history&a=11&b=12#version-content-panel

Great news but not as simple as that WF as not all uses of doxorubicin necessarily involve the presence of FAP as FAP is not necessary for doxorubicin to work. Set against that there will be many more patients who will be eligible (the elderly, and potentially those with heart conditions) and for longer.

However it will take many trials and a lot of time to get use in additional indications approved, mainly due to combination therapies needing to be rejigged to optimise them, but increased potential market, yes definitely!

Filtered. You're just a fool.

Just a reminder that Thornogson/NDN/Eggy is not invested and always posts in bad faith - meaning he misrepresents and outright lies - and so has no credibility.

Just a reminder that Thornogson/NDN/Eggy is not invested and always posts in bad faith - meaning he misrepresents and outright lies - to provoke argument and try to adversely affect sentiment.

There is absolutely no point engaging in his spurious arguments.

@IFA90, yes, that's because the topic of the webinar was 'Phase 1b Faridoxorubicin (AVA6000) Salivary Gland Cancer Data Release' and the Q&A's are as per the video recording.

Good to see that the text has been tidied up compared to previous webinar transcripts - faridox and not ferry docks!

B2HS2L wrote: "[I know of no other company that would : ] start AVA 6103 ph1a in four indications "

And in two dosing regimens 2-weekly (Q2W) and 3-weekly (Q3W).

Do Not Use Conventional Logical Proofs

• Do not expect facts to work: Fascists often prioritize "black-and-white thinking" and emotional narratives over evidence. They may dismiss reputable information as "fake news" or "liberal propaganda."

Or in this case, "Avacta aren't telling the truth".

1. DO NOT ENGAGE

2. DO NOT ASK IT A QUESTION

3. DO NOT ANSWER ITS QUESTIONS

4. DO NOT MOAN ABOUT ITS POSTS

5. DO NOT ARGUE WITH IT

6. If you must do something. Mock it with reference only to its stupidity and nothing else.

The Chinese have recently become prolific authors in both preclinical and clinical pharmacology.

With the appointment of Strand Hanson in place of Peel Hunt, which does not have a presence in China or SE Asia, maybe Avacta is looking to the Far East for funding?

https://www.strandhanson.co.uk/emerging-markets/singapore

"Strand Hanson is proud to work in collaboration with PrimePartners Group, one of Singapore’s leading investment advisory firms, to leverage business connections and maximise value creation.

"PPG holds a Capital Markets Services license from the monetary authority of Singapore and undertakes advisory and capital-raising activities for clients around the globe, with an emphasis on South East Asia and Greater China."

HC, why are you playing whack-a-mole with Thornogson/NDN/Eggy?

No sooner has one talking point been discussed to death than it's on to the next talking point, then the next, then back to the first, then the third again, and so it goes on, endlessly, AS LONG AS THERE IS A FOOL WILLING TO ARGUE WITH HIM. At the moment you are very much that fool.

Surely by now you've realised that that persona always posts in bad faith? No credibility, no integrity, will keep making the same discredited, unfounded arguments because he is not interested in learning, only arguing and causing disruption - and earning his crust from TW.

Yes, that could be one possibility.

@russell1, what deadlines has Avacta missed since CC became CEO on 1 May 2024?

Whilst the introduction by the host was current (post-IND announcement), CC seemed to be referencing passed events as being in the future and someone here suggested that the interview was recorded last year, in early December if I remember correctly. I haven't listened to the interview again today but I do remember hearing bits that seemed out of step with today's situation.