Member Info for Grace83

Thanks oldbaldy. I’m just a geek really and have been more than happy to have something to research.
There will be much more knowledgeable people than me to have a guess at possible funding for the next stage 2/3 trial and possible share prices.
Just don’t want everyone to be building up too much, as hopefully people will have realistic expectations of what to expect from trial and into the next.

Glad your day has just improved! I’ll probably have had too much to drink soon, to be able to post for much longer :)

The funding of the next stage isn’t a concern for me at present, as we do have a good pot Of cash to be moving forward with, which should last a good while. As our sample size will be much larger with the new participants from the extended trial, then it will be considered to be a very robust trial too, With solid results, so there should hopefully be multiple funding options available, which I can’t see Val needing to dilute the share price for. Also by that time, the share price will have increased substantially, as we would only be going to the next stage of trials if this one is successful, which would naturally substantially increase the share price upon results. This would make Val a much more interesting company from the point of view of others and we would be in a different position by then, hopefully!

Viera
Well the primary endpoint of the trial is to determine the maximum and optimum dosage. Secondary endpoints are a range of factors including tolerability to the drug and also the efficacy of it. So to be honest, they won’t really be looking to see if it’s actually shrinking tumours yet. That’ll be for the next trial at stage 2/3. We will have an idea from this trial though, obviously, but the focus of the scans Conducted during this trial are to see that the disease isn’t progressing. As far as I can see so far, the trial appears to meet all of the endpoints at this stage. A further trial at stage 2/3 would then require more participants (a lot more) and cost a lot more money, so we would maybe have to look for a partner. This would then Be able to focus more on exactly how effective it actually is at shrinking the tumours. At this present time, the data to Show the slow down and then even decrease the psa is more than enough, as this gives us the biggest indicator that is works. We also have the stable disease data for all but one of the patients which backs this up.

Personally (and this would be a long way into the future, if this drug was to be approved) from it’s behaviour so far, I would guess that looking forward, this would be effective at an earlier stage of disease for the wider market, perhaps at the active monitoring stage. Most people generally aren’t happy to actively monitor, as they are clearly worried that cancers will progress, so they opt for treatment, which, in the form of chemotherapy and radiotherapy is nasty. Which sometimes means that they have unnecessary treatment, so if you have a drug that is safe and doesn’t produce side effects that stops anything growing, I suspect that people would be happy with that, as prostate cancer is generally quite a slow growing cancer. Just because the only people that we can find for trials have no other options, doesn’t mean that this will be the best use for the drug. Obviously if it did reduce tumours then brilliant and that’s what we are all hoping for ultimately.

Regarding share price, I’m afraid I don’t have as much of an idea as a lot of you, as I haven’t been investing that long, relatively. In response to Baxter’s, I’ve only held one aim share since last year and it’s only been this year that I’ve been investing further into many aim shares I now own. Before that, I primarily stuck to FTSE, but this is much more interesting. You won’t see me comment on most of the bbs that I own shares in on aim, as I won’t comment if I don’t feel qualified enough to add value to the bb. For instance I know nothing about gold so what’s the point in me spouting nonsense there...

Oh and I left out that as 201 is so well tolerated and doesn’t produce any nasty side effects (Which believe me, Is almost unheard of in cancer treatments) then the dosing frequency is to be increased to daily, from weekly. To give it an even better shot at reducing tumoursin the extended study.
Is that everything, or have I missed something major?

Have a good one baldy...see you Monday :)

So the basic upshot is this has the potential to shrink tumours. And even in the worst case scenario, can stop them growing...?

I’ve been looking at the raw data so far available from the first trial, before it was extended. These are my observations and I’d appreciate any feedback and additions from people who were around at the time these were being presented.

Firstly, all patients enrolled had already exhausted other options and were no longer responding to chemotherapy. They were all in progressive disease before commencing the trial. During the trial, all participants except one (he was at one of the lower dosing levels of 2mg/kg) demonstrated stable disease, which means the tumours weren’t getting any bigger. So it can be conferred from this that 201 was stopping the disease progressing. This is backed up by the fact that All but one had their tumours Start to progress again after finishing the trial, when they were no longer on 201.

Secondly, the data confers that as the dose is increased, the psa doubling time is generally increasing. This is an important thing to monitor, as the shorter the doubling time, in general, the quicker the disease is progressing. This beneficial effect isn’t consistent However, at the lower dose levels, as it appears that some men were responding to it, whereas some weren’t at these lower doses. The important thing Is that by the time the highest dosing levels of 4mg/kg were reached, ALL of the participants were experiencing their psa doubling time increasing dramatically. In one case, the patient even had his psa decrease by 30-40%! The lowest level of benefit In this 4mg/kg cohort was one patients doubling time increasing from 2.9 months to 7.5 months. The best level of benefit in this cohort for the doubling time (Apart from the obvious guy who had the big decrease in his psa) was an increasing doubling time from 8.9 to 43.1 months. The 5mg/kg patient isn’t included in the early data I can see, but in the presentation, George said that he was seeing a reduction in psa of 40-50%, but the trial was still ongoing for this patient.

So for the follow up trial, the dose will now be increased to 8mg/kg. They didn’t go to the full 16 mg/kg as I’m presuming that this was the adverse event That has been mentioned. The follow up trial will therefore increase the number of overall participants, as they will be added on to the data for the first trial, so we will have a much bigger sample size to go from when these results come out. So sample size doesn’t concern me, as we will end up with a very healthy sample size.

So for me, as a biologist, I’m excited for the results...Thoughts anyone?

FBNO
Seriously, I’m impressed that you held. As a new investor, you must’ve had a bit of a sleepless night. Take a step back, look into the company as that’s the reason you should be here and read the sensible posts. Look at the patterns of the sp. Lots and lots of lessons to learn on AIM and I’m still learning some of them too.

Yes I did. Thanks for your reply, it makes a lot of sense. I know it’s caused a bit of unrest, but I’ve enjoyed the Recent posts where people are genuinely weighing up this stock, as it helps to put a bit of perspective here.
I believe the gamble will pay off too :)
Oh and I’m with you, in that my other stocks are much more boring than a select few in AIM!

Oldbaldy
I didn’t say it was the best strategy mind! It’s clearly a gamble, as scientific results don’t always come out the way they are hoped to. I’m happy to take the risk, after writing everything up, but you need to weigh this up for yourself. Nothing has changed today for me, some pump and dumpers are gone and that’s fine. It all would have been on the 201 results anyway, for any investor who is not a day trader and that’s why I bought in.
I know why you bought in originally, but may I ask for your honest reasoning for topping up on your original £1000 recently?

To be honest, it’s all background noise. I’ve made my bet on the results of 201, so that’s what I’ll be waiting for. Obviously I’m hoping it will, to help calm some nerves here.

Haha...yeah it was a typo. Not getting that carried away yet! Although we can always hope...:)

Thanks bananaman, that’s very helpful. I’ve now changed my limit order from 17.6 to 17.7. Nothing yet, but will see if that works in the next hour or so. I’ll use the time to check out the proactive interview, by which time I may have to increase the order anyway. All looks good here on an initial scout and from your info, so I’ll be happy to be invested, if there are any shares at all to be had! Cheers :)

I was just about to post. Only trying to buy £500 as a punt, before I have time to properly research. That won’t even go through!

Bananaman, sorry, I didn’t see this as I was typing my
Response. Yes exactly! I don’t see any sinister reasons for extending the 201 trial, only exciting reasons :)

Great post by maths prof.
For 201, I see this as much more of a positive than him/her. The trial was extended because they were then granted permission to hugely exceed the previous maximum dosage of 201. Which means that whatever results they achieved in the first trial, could possibly come out better in the extended trial. This was the main thing that made me invest personally, as everyone in the company would have had a set of results ready to look at. This is why I think the directors have bought shares, as they already have access to the first set of results and can see they are good (pure speculation obviously, but would they have done this if the results weren’t good? It’s derisked for them, as they already have data to go from and it could possibly only get better from there). If it were me, as a company, I wouldn’t have released the first dataset either. It makes sense to publish just the extended version. Would you want your company to release ok/good results or possibly excellent results? I’d go for the latter.

Maths prof hit the nail on the head with 401. It really is an unknown, having only seven patients for the dataset. They tried to recruit 20, but proved difficult with late stage lung cancer, as it progresses very quickly. Out of the 8 recruited, 1 died and they only managed to get two patients in that were well enough to scan them, which did actually show that it stopped the cancer growing at that scan (so 100% success rate, but only on two patients, so would unlikely be statistically significant). I can see why they are having difficulty with progressing with trials, due to the nature of end stage lung cancer, as it’s difficult to recruit people. Another positive was the data shows the drug did Make people feel slightly better, in a number of ways. But again, for such a small dataset, you’d need a much larger trial really.

Oldbaldy, I did notice today that they were removed. I wonder why? Good luck if you do decide to invest with SNG :)

I’m only here because of a cross ramp on the SNG board from Mr Nation. When I then arrived to do a bit of research, it was easy due to helpful people like him posting an overview of the company. This made me get in quickly with my first buy. When I had more time to do some proper research later that week, I topped up big for the first time. Then topped up again with a little one again yesterday.
So overall, I’d say he really adds value to this share in more ways than one.

My small top up of 6000ish shares took half an hour earlier

Haha, I bet you wished you hadn’t posted there now! I should know better to shut my mouth, but can’t help it sometimes, when people are being rude.
Don’t worry, I can clearly see this BB is great. I’m so impressed with the people here who have essentially saved this company.
Pretty sure that I ended up doing my research here as a consequence of a cross ramp on the SNG board from MR Nation. So I’m very thankful to him for that! Came here a few weeks ago, have topped up once and about to again tomorrow. Roll on the next few weeks :)
GL :)

Thanks HunSen
It’s a bit intimidating posting for the first time! I’ve only been here for a year, but will also be holding. This company has some excellent products that do fulfil currently unmet needs and I’m also excited about the possibilities for Ditest. Lots going on here. With Alkindi orders increasing year on year in current territories, not even factoring in the USA. Chronocort after approval in Europe next year accessing an even wider market Of adults, as it now demonstrates superiority over the current standard of care. I feel for LTH, but quietly confident that we will get back there, as everything has been put back into place. Waiting eagerly for that FDA announcement now...