Member Info for rhubarbmk2

As Rightback says, nothing will significantly shift the SP of this Company now, without an established partner. But when there is one, with a MCap of 16M, shift it will. GLA.

I also think they've tapped into the idea that Big Pharma have inherent obstacles in dealing with bench scientists at two ends of the financial-academic spectrum, and want to capitalise on that via facilitation. Smart, very very smart.

Very positive for me. Quality management; strong acquisition/evaluation/outsourcing plan for new candidates; they won't hang around too long before proceeding with 301; 401 has more legs/potential than folk realise; and more like when, rather than if, VAL201 will be partnered or sold. As a Shareholder, not much not to like, and as scientists, they're tight alright. I think the Webinar will be available later to view Grace. And I think Suzy smoked you out with the castrate resistant question :-)

What about a turn to the camera zooming in, and a sly wink. That'd do it wouldn't it.

*hen's teeth - sorry; very unusual for a cancer drug that actually works.

Grace is spot on, as usual - I can tell she's a biochemist :-). I'm more your biology side, so hopefully we can work through it as a group. Essentially, no; the MTD was not established, which is, in my experience, like he's teeth in oncology, in a very positive way (low toxicity). The injection site reactions are "meh" to me. You're injecting protein, so there will always be a bit of a local subcutaneous reaction to that - always is. And they will probably monitor blood pressure in any extended trial, given the "flag" in a predisposed patient. But it looked like they already had hypertension pre-trial. The results are tantalising, and I'm glad that they waited, if true that any offer was on the table previously. They are better than the headline results, in my opinion, because they give more of a sniff of a dose-response. As Grace says, you can, to an extent, look at the higher doses to get a better view of the potential. I'm not aware of any liver "flags", but others' may wish to contribute. Over to you, Grace, me hearty, when you've deposited that gold. A1b2c3 is right though :-) :-) :-)

Hi Tommy. Yes, I can answer that. The preclinical testing in the rat dosed up to 100mg/kg. Despite this, there were species differences in VAL201 exposure (much higher levels in human blood were detected at much smaller injection dosages, when compared to the rat). Therefore, it was decided that higher doses couldn't be tested in man at that time, because there would've likely been other restrictions in the human study protocol, to override the initial allowance to go up to 16mg, if exposures in humans exceeded those tested as "not adverse" in the rat, irrespective of injection dose. Hope that makes sense. Also, I expect that money was running out at the time, shareholders were abandoning ship, the trial had probably gone on long enough, and the decision was taken that VAL thought that they already had enough "proof" that VAL201 would work in a further trial, with higher doses, a new study protocol, in different indications etc... at partnering stage. ATB.

It's very fluid isn't it. Essentially, it's all up in the air with the Biotechs, until they have a concrete partner. Although I'm personally glad to be in at a low MCap "speculative" stage, based on the characters involved, their demonstrated behaviours, and a preliminary assessment of any available data. It's the ones still with the finger in the air, but with a high MCap, that I'd be very nervy with at this stage.

Poor Suzy is currently probably on her 328th e-mail, trying to find a question for next week, that doesn't ask about the JVs for 201/301. ;-)

So, we can count you out for the ValiRx Shareholders Christmas Party, I take it, Sach?

To be fair Stach, although I'm sure that most would agree that the trial could have been run at a more effective level, notably with regard to the speed and scope of recruitment, you kind of shafted your own argument with "most are stage 4", followed by "PSA have not become normal or disappeared ". And we both know that you are purposely or mistakenly conflating the primary objective of a Phase 1/2a trial. If there is a drug that achieves the above, btw, please do inform us, because, as a cancer specialist there must be one that you can reel off from respective peer reviewed manuscript?

This is applicable to me, too. Limited downside to be had. The company is strong, committed and diligent, but treads lightly. I thought a few weeks ago (I may have posted something) that I didn't think that the full results would shift the SP notably. It's a very busy data set. I also thought that Suzy wouldn't write an RNS like many others would, such as "it shrunk the metastases in patient X". Obviously this would cause a spike, and we may have recapitulated the effect we saw with the initial headline results, choca-bloc with shorters, but I genuinely think it would've been short-lived. A much more sustainable rise would be achieved by finally nailing the VAL brand to an established partner, with a revenue stream. You'd get a spike, but it would settle much more controllably, and the SP would then have a defined and solid foundation as a base to work from.

The dataset is thin, but wide. Investors elsewhere probably haven't dug done into it, but any potential suitors will be doing that now. There appears to be evidence of efficacy in metastatic and castrate resistant patients, with the potential for a dose-response, and a further potential to dose higher. 3rd parties will spot the same trends as others have here, which, after all, is the critical path to a potential JV, and some welcomed sustainability.

Hi Grace; 1, 5 and 8 were resistant in my recollection. 8 very exciting, as seems to have a resistant secondary. Yes, question was around deeper data, but you should email Suzy anyway, because I think she'd like to hear from you! Have a good day.

Mathsprof is right, 14 falls short of the criteria, despite the apparent stasis/decrease in metastatic growth; again reinforcing the importance of looking individually at the stand-alone structural and functional biomarkers. Despite my earlier post around the combined means of PSA doubling time, given the heterogeneity of these patients, it would probably be more prudent to assess any efficacy on an individual basis. For this reason, patients 11 an 12 are particularly catching my eye, because they have lymph node and/or distant site involvement. Hopefully any previous medical history and evidence of anti androgen insensitivity will reveal just how useful 201 is in this poorly-served population. There was a hint preclinically in metastatic suppression, so if this played out clinically, it would be very exciting indeed.

Indeed, and a fairly decent biomarker to be fair. Try taking out the lower doses, and then running the mean PSA doubling time, pre- and post-treatment, even discounting the the "infinite" doubling time in patient '008. Plus, it's still only a mono-therapy, there's no combination here, and this is a seriously high-bar of patients to go in at. Dream scenario would be to push those doses further, in an expanded Phase 2b, and maybe use some potential JV revenue to run some preclinical bridging studies in more female repro and breast models. Safety profile still looks remarkable to me, and certainly would "enhance" the "patient experience", looking at most of the other alternatives.

How many AIM outfits can you e-mail with a question about the clinical data, and get a reasoned, polite, and very friendly response (my question will be addressed at the webinar), straight away? Plus, I know that this would be the case for any interested shareholder.

This Company, to me, oozes competence, professionalism, and a genuine high regard for the LTHs. Not to even mention the IP.

That's why I'm in.

Grace - I wondered momentarily if the wrong box had been ticked myself - i.e. 6 cycles completed, tumor shrinkage, and increased PSA DT on a decent window of dosing. But I suspect that there is something not getting this into the criteria, which shows they may be imperfect, and other parameters should also be viewed. Scrap the lower doses and look at the PSA doubling time in 6/6 patients treated with 4/8 mg. This presentation is really neat, kudos to the team. I'm really encouraged by this.

You should send these to Suzy Borsaci06; I'm sure she's aware of the nih funding opportunities, but she's always pleased to receive anything that may be around.

She say's Grace is spot on, but I need to work harder - C+.

Of course they read the boards; any good company likes to keep their ear to the ground with their enthusiastic investors, and what better way to do it!

Talking of which, old silver, which one are you? :-0

Maybe someone should fire her an e-mail for a last-minute QandA question:
"Suzy, what's your handle on the lse chatroom, please?" :-)

Could be "spoofing" activity. Trying to walk it down little by little.