Member Info for Bella6532

June, June, June....

If I was a betting person, I would put my money on Patient Recruitment being probably the biggest factor if the 2 weekly trial has been delayed...

....studies have shown patient recruitment issues are the cause of 85% of clinical trial delays.'

https://www.pharmacytimes.com/view/accelerating-patient-recruitment-may-help-address-clinical-trial-delays-in-fda-approval-process

The US has suffered from difficulties in patient recruitment from many years....

BV...there are many reasons why we haven't had any news...It could, as Icecool has said, be down to the FDA. It could be due to negotiations with a third party, it could be due to a patient saying yes and not turning up for their dosing, or supplies of AVA6000 being delayed or even a black cat walking across the road etc etc etc...

The US had the same issues as Europe with flue, Covid and other diseases so again this could have been a factor from the point of view of patients and staff....

https://www.usnews.com/news/us/articles/2024-01-03/more-hospitals-are-requiring-masks-as-flu-and-covid-19-cases-surge

We can speculate on it being just about anything and so we are just going to have to wait and see I'm afraid.

We also have to remember all the trial patients were terminal...chances are they may

be in quite a poorly state with very week immune systems etc. Now if AVA6000 is showing efficacy for some patients with late stage/terminal cancer...what might be the efficacy rate if administered at early diagnosis stage.

07-Feb-24 09:42:47 102.50 100,000 Unknown* 102.50k

They always appear before one or two large orders finally appear either during the day (like the one this morning) or after hours...funny that!!!...coincidence I think not.

Trading patterns back in work through mode...

Sounds like he's having targetted radiotherapy.

Oh and did you consider a third party might have wanted Fionas replacement brought in...it happens!!

Viking.Raider...of course it could fail...however, it's highly unlikely given the new 2 week dosing. AVA6000 is not the 'active' ingredient, Dox is, and that works. AVA6000 is a carrier and takes the dox to the tumour and releases it in the tumour reducing substantially the side effects associated with Dox being left to find tumours itself and it has been shown to do what it says on the tin. Will it stop doing what it says..I doubt it. It allows the Dox to be dosed a much higher levels which give Dox a better chance of killing the cancer cells quicker.

For me the risk AVA6000 will fail is pretty small...

Has a form of cancer...this disease can get anyone at anytime...regardless of your status...

It's not prostate cancer apparently...and he is receiving out patient treatment...

All the very best your majesty...

Trials are just that...Trials...and many fail and some even fail dramatically. We are still only early stage 1a with ARM 2 data still pending...the main markets won't jump in until they're really sure and that will be when the science is validated by a PB or results. Buying into unvalidated science on AIM is the huge risk we all take along with a few venture capitalists etc...you have to have nerves of steel in this game and do plenty of research. I for one am happy right now especially with the recent acquisitions. We are no longer a one trick pony...

One of our products is also in the hands of a BP now through the Eli Lilly purchase of Point. They will have access to our science and we just hope they continue to push it through trials.

They don't need to de-list on AIM as they can have a dual listing.

The immune system can go rogue once switched on...this happened to a friend of ours who had immunotherapy for cancer and the side effects were horrendous. He was told by his oncologist that there is no way they can turn the immune system response off once activated they just hope it turns itself off itself once it's done it's job on the targetted cancer cells. His eventually turned off after it did some damage to good organs and within a matter of months his cancer returned and was more aggressive ...when asked why? He was told it happens and they don't know why...he died within a few short months after that.

Avacta has a far safer mechanism...

Hurst10...why not a Reverse Take Over...far easier way to get a US Listing.

Https://avacta.com/therapeutics/therapeutics-team/

Dr. Christina Coughlin, Chief Medical Officer at Immunocore,

Did any of you not wonder why she was bought in...?

Immunocore's world-leading science and strong IP position has attracted major pharmaceutical companies including Genentech, GlaxoSmithKline, MedImmune, the biologics division of AstraZeneca, via discovery collaborations, as well as a co-discovery and co-development partnership with Lilly. The Company has also entered into combination trials with its lead programme, IMCgp100 in melanoma, with Medimmune and Lilly. Founded in 2008 originally out of Oxford University and headquartered outside Oxford, Immunocore now has more than 185 staff. Immunocore's current investors are well-renowned, leading international institutions including Woodford Investment Management, Malin Corporation, Eli Lilly and Company,

DTW...Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries.

Phase 1: ARM 1 = 3 Weekly Dosing

Surveillance every 6 weeks

Cohort = Dose mg/m2 (Dox equiv) = 12 week cumulative dose

C1 = 80 (54) = 320

C2 = 120 (81) = 480

C3 = 160 (108) = 640

C4 = 200 (135) = 800

C5 = 250 (169) = 1000

C6 = 310 (209) = 1240

C7 = 385 (260) = 1540

AVA6000 phase 1 ARM 1 (3 weekly) data cutoff 27 Nov 2023. Cohorts 5, 6 and 7 have all patients ongoing at the time of the data cutoff, thus safety findings in these cohorts will continue to mature.

Phase 1: ARM 2 = 2 Weekly Dosing

Surveillance every 8 weeks.

Cohort = Dose mg/m2 (Dox equiv) = 12 week cumulative dose

C1 = 160 ( ) = 960

C2 = 200 ( ) = 1200

C3 = 250 ( ) = 1500

C4 = 310 ( ) = 1860

They do not show a C5 stage so not sure if they will go beyond C4 as it was only supposed to be a short study.

https://avacta.com/wp-content/uploads/2023/12/AVA6000-Data-Release-13-December.pdf

"Across the board we're proud and encouraged by the momentum we're seeing in both divisions of this business and see huge potential value both for patients and investors in the next period."

Huge...Next period...was that H2 23 or is it through next Interims...so up to end June 2024.

Huge is quite a big word...