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From the trial protocol....

"Drug: AVA6000

AVA6000 is a FAP-activated prodrug of doxorubicin. AVA6000 will be administered via IV infusion every 3 weeks. Dosing will occur based on the calculated patient's BSA on the day of dosing"

Imagine if a patient presents an individual patient image data at AGM

I think trial includes imagery (FAP-PETI) but some form of monitoring would be standard practice. At some point.....

Lol.

Imagine if AS presents an individual patient image data at AGM.

People in the trial are volunteers. They enter the trial with the balance being benefit to others rather than themselves.

If the trial therapy appears to benefit them then everyone here should forget the point scoring, the playground insults and the football my team is the best attitude and chill. It's just fr/cken brilliant. Grab the poms poms and celebrate for that human.

From an investigator point of view if x dose appeared to benefit the patient then yes continue at that dose especially if there is no data available at higher doses - after all its still an experimental therapy - softly softly. However, if data emerges that a higher dose is likely to benefit thus volunteer to a greater extent then you would have to be some sort of demented idiot to suggest this volunteer should be denied thus opportunity because they might soil your data.

Apologies I'm really p\zzed.

Ex-china?

I like the fantasy calculator. It saves me p/zzing I'm my pants when I want warm feelings

Full Metal Jacket?

I've borrowed the fantasy calculator and am rounding 49 up to 5000. If a post it enough times I convince myself it's a fact.

In response to PL and at the risk of watching shadows on the wall.

The decision to continue treatment beyond the trial schedule would be on an individual patient basis and the response seen in that patient. My guess would be

1. Only patients seen to have a response (e.g. no disease progression) would be continued.

2. Patients not seen to respond wouldn't be put on treatment at a later date as Cohort doses increase

3. The dose given would initially match the dose they responded too - wouldn't be higher since that negates the 3+3 rationale and carries commercial risk (eg higher dose given and SAE experienced)

4. Has evidence of tolerability at higher doses emerges the clinician could consider and apply to have the compassionate use dosage increased if there were reasonable grounds to believe benefit outweighs risk.

All guess work but I think the reasonable man approach works well in these scenarios. What you cannot do is go at it like a pig at a tatter on the basis that if a little is OK then bucket loads must be great.

Can I borrow the fantasy calculator. You know the one that uses daft assumptions as a power source.

Achondroplasiaphobia

Slide 85 of SD states STS for phase 1b

Slide 87 states STS, breast and ovarian has I initial markets.

Funding likely to be available for STS as orphan. I think k momentum there will encourage BP to do heavy lifting with other indications otherwise will be staggered approach.

STS ava6000 has clear differentiation against other options.

TL - its reasonable question for anyone to ask especially without a clinical background.

The way drugs are regulated in the UK is you need a licence in order to sell them. Use within clinical trials is permitted but they need to be approved by ethics who consider whether the scientific rationale meets a standard Inc potential benefits and risks.

The first stage is phase 1 where the pk (how the body handles the drug) is examined. Could be done in volunteers since efficacy is not being looked at. For Ava6000 the presence of fap containing tumours and therefore patients who are seriously ill. They are also not receiving concomitant medication - this would cloud the pk picture. Indeed these volunteers have chosen to receive a drug which may not benefit them and indeed may do them harm. It is humbling. These patients are not indicated for normal dox and wouldn't be likely to benefit from it outside the trial.

Without treatment cancer does progress. Lots of factors affect how fast and how seriously. Slowing this progress down is a big part of treatment. At SD the message was dox doesn't cure at the doses used but it puts a brake on it. When dox stops the brake comes off.

So it is fantastic news that an experimental drug given to patients who have limited options available has resulted in their condition not progressing. Added to that it appears well tolerated.

To do this the clinicians would have to accept clinical responsibility - it's no longer directly controlled by same committee although their organisations probably had some governance involvement. Again signs that it is an approach that carries benefits that outweigh risks.

Suspect they will cap the number of cycles and duration.

They will then add an extension so patients can opt to continue on treatment. This generates more data but doesn't prevent the analysis between groups proceeding.

Ah - makes sense and thank you.

C1-4 had 19 patients

From rns "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"

I don't think market is ignoring the data. What they know is that every three months our loan shark will dump a load of new shares thus suppressing the price. I think we are attracting new investors - their demand is being met by this supply rather than other sellers.

That said will be interesting to see what the shorts do today. If anyone is as thick as mince it's them.

The decision to continue treatment beyond the trial will be taken by a senior clinician (who then accepts responsibility), the patient (who needs to be fully informed) and the company.

Several patients in C5 suggests that momentum building behind this compassionate use. It demonstrates belief from the three parties. Its bloody fantastic for patients too - wouldn't be an option if something better was available.

For the more commercial it does mean more long term data coming out earlier than would be. This RNS sets up the AGM

Pretty cool find