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The emerging positive safety and pharmacokinetic data from the study support the potential clinical differentiation of AVA6000 over doxorubicin. This includes: (i) higher dosing of AVA6000 compared to standard doxorubicin, (ii) more frequent dosing of AVA6000 compared to doxorubicin - doxorubicin is typically dosed every three weeks in order for patients to recover from the side effects of treatment, (iii) the ability to administer many more cycles of AVA6000 compared to doxorubicin.

A total of 29 patients with a range of advanced and/or metastatic solid tumours have now been dosed at the clinical trial in sites in the UK and United States. On the basis of the very favourable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has recommended continuation to the sixth dose cohort at 310 mg/m2, which is equivalent to 2.7 times the standard dose of doxorubicin. This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the Phase 1b and future studies.

Yet the share price dips!

Looking forward to more detail on the statement “Several patients remain on trial in different dose cohorts and continue to receive AVA6000 as their disease has not progressed“.

Wiggy looking pretty blue so far! Let’s hope the fireworks come tomorrow too!

I was disappointed that Ben was paying off the convertible loan notes as this put the prospect of dividends off for some time so I sold out but I’ve bought back in a small holding at 12.5p. Avani bought at 18p and they had access to the books. They’ve provided a loan after the current issue and will have much more knowledge and sight of how good an investment this is than I have. GLA

Not a deramp but in view of the excellent news I just wonder why the BoD don’t seem to have bought any shares. Could it be this is regarded as a ‘closed period’ ?

It would certainly send some clear signals if they invested significantly themselves!

BTW I’m fully invested via my ISA here so I have put my money where my faith is.

Excellent news! 👏

Thanks for your research Penstock, I valued your always well thought out contributions. Wish you and the family all the best. 👍🏻

But I wish they’d hurry up! 😝

I know that the longer it goes on then hopefully this means the more dox that can safely target the tumour but the market doesn’t like uncertainty. RaH posted about possible timelines for the latest cohort - which have expired. Be good to get some sort of update at the AGM if not before then. Thursday RNS please big Al 🙏

?

A bonus RNS today but the big one ☝️ is yet to land!

Appreciate your contributions Penstock. Let’s hope Ben builds up the coffers and announces their first dividend soon 🤞

Thanks RAH!

Fair one RAH0084. 😉

No one else worried about what seems to be a relentless drop in the SP? I’m not after a daily update or concerned by daily SP fluctuations. I bought in and since I’ve topped up a few times so for me I’ve a significant holding here. My post was just to say that we could do with news and an update might help to stabilise the SP. Each day without news seems to see further drops.

Big Al has also said he will let us know at the start of each cohort. Are we mid cohort? Or close to the end of this cohort? There’s the rational side of having considered this as an worthwhile investment against the emotional side of seeing a paper loss so far = Nail biting emoji. GLALTH

I know big Al said if we don’t hear anything then it just means they are getting on with it (in his vox interview) but in view of the drift down in SP we could do with hearing how the trials in the UK and USA are going. It’s been three weeks since the first US participant was dosed and six since the first UK participant of cohort 5. Arguably this would be market sensitive information if there were any toxicity or if there is not any in these trial participants that the company has a duty to release in a timely manner.

I’m a holder but can understand investors getting spooked by the paper loss that we have seen. Hopefully big Al has an eye on the SP too?

My only concern here would be if the company acquired another diagnostic division. As this would make me question their ability to prioritise (and their confidence in) their oncology drugs. Why else would they use the funding that could see these trials through to completion?

Happy to hold and to add :-)

I’ve been refreshing what I’d read before about 3+3 design of clinical trials and trying to understand exactly how the two RNS notifications of dose escalation (5th April and 27th April USA) of the participants enrolled into the current 5th cohort would fit into this.

3+3 design.

The traditional 3+3 design was originally introduced in the 1940s as described by Storer in 1989. In a “3+3 design,” three patients are initially enrolled into a given dose cohort. If there is no dose-limiting toxicity (DLT) seen in any of these participants, the trial proceeds to enroll additional participants into the next higher dose cohort. Dose-limiting toxicities are generally defined as clinically relevant toxicities grade 3 or higher by the Common Terminology Criteria for Adverse Events. If one patient manifests a DLT at a specific dose, an additional three individuals are accrued into that same dose cohort. (I.e. 27th April?)

Development of DLTs in two or more out of six patients at a specific dose level indicates that the MTD has been exceeded; further dose escalation is not pursued, and the prior dose level is expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD. The MTD is determined in the first cycle of therapy (often about 4 weeks, but this could be allowing for the usual time of a cycle of therapy between doses plus time to monitor for side effects?). The MTD is therefore defined as the highest dose level in which six patients were treated and, at most, one patient experienced a DLT during the first cycle of therapy. If more than six patients are treated at any dose level, the MTD is exceeded if more than one-third of the patients experience a DLT

So if a dose limiting toxicity was seen in one patient from the 5th April group that dose level could have been repeated in the group dosed on 27th April in the USA to see if this is the maximum tolerated dose? As this Thursday will be three weeks or so from the notification on 27th April we may perhaps see some news about the maximum tolerated dose released then?

See https://ascopubs.org/doi/full/10.1200/EDBK_319783

Could be a great time to buy some more?

The current share price does not seem to reflect the potential value that I and other investors believe the company has demonstrated in their early clinical trial results. I’m open to contributors questioning why and so I welcome Wyndham and others viewpoints. What I don’t enjoy is the overlay personal attacks as they and the responses to them clog up this chat board with drivel. I’m holding and happy to hold but as an investor I’d like to see my investment increase and when it isn’t I’m curious as to why it isn’t - hence my reading this board. Can we please move on to just discussing the company and share?

Doesn’t the trial show that 72hours after each dose they check renal clearance etc? So if participants are getting dosed every 3 weeks (and one of the stated endpoints is reaching the maximum lifetime dose of dox), isn’t there at least a chance of another RNS highlighting the extraordinary progress of getting dox without side effects by the end of May?

I also value Wyndrum’s posts, although I don’t always agree with them it helps to have alternative views here and I think he often offers some unique viewpoints.