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Hi Noise I remember getting excited about Val:). Another important point from the video is the dose frequency, These results were based on weekly with a half life of 3 hours dosing, they want to be dosing daily so now with all the safety date that shouldn't be a problem in the next trial . If this is right the results from the next trial when the outcome is to actually test the drug works we should see far better results.

Even if the results from the current trial aren't fantastic they only need to be good enough to get a partner for the next stage to increase the dose frequency. They should be able to evidence this quite easily.

Hi wishful long time no hear. I don’t think he’s employed but I get the impression he maybe as a consultant.

https://www.sharesmagazine.co.uk/video/valirx-val-dr-george-morris-chief-operations-officer

It was in the Edinburgh presentation 22nd November 2018, I did have the booklet from there’s but chucked it out a few month ago. Well worth a watch to remind yourself what could be coming.

Noise I’m pretty sure there was a 5 mg patient aswell sure this was in the slide from the last presentation

Patients were scheduled for treatment of a once weekly injection of VAL201 in 3 week cycles for a maximum of 6 cycles. 4 patients completed all 6 cycles, the remaining 8 patients were withdrawn prior to completion, with valuable data being collected from all 12.

Stage 1/2 trials are never very big, the drug is untested on humans and nobody can be sure it works, its hard enough finding someone with all the right criteria but then you need someone willing to try an untested drug.

They have enough information from this trial otherwise they wouldn't have stopped it, they need sufficient evidence to progress to the next stage. They announced in May that they have good data from all patients. The main data they need is that the drug is safe and tolerable which they have. To get a deal with a partner they need to be able to prove the drug is efficacious which is the big news we need. We've had indications from the company that the drug works at smaller doses over a relatively short period of testing. we now need the data from the last 3 year and higher dosage.

You can be pretty sure the exercised warrants will have been sold over the last few days so nothing to worry about. Nobody in there right mind would exercise warrants now to hold.

Remember guys this was a trial where they have to try thing to see if they work. 16mg/kg might be to much and that's great, the primary endpoint was to find out the MTD (maximum tolerated dose) so they've probably found that out. 8 Mg/kg is the dose they've been given so it's safe and tolerated at the dose which is the secondary endpoint. Thats all this trial was about find the right dose and find out how safe it is. The benefit of running an oncology trial is you can also assess how well the drug is doing in its basic form of is the patient still alive and what is his quality of life. The were also receiving regular PSA tests and CT scans to monitor tumour growth if any and also metastasis.

I don’t know what your trying to say but im sure on the previous data release there were only nine patients results. The number of patients is fine for this early trial stage and it’s very difficult to recruit patients.

Most of these patients will have been at the end of the line treatment anyway having exhausted all other avenues lived with easy access to the hospital testing and healthy enough to get there. The fact that they remained alive through all 5 cohorts to reach 8 mg.kg is quite something.

At least since the first data release a few year ago.

Have I missed something or is this the first time the dosage number of patients and number of cohorts been mentioned?

https://www.fiercebiotech.com/biotech/partnered-and-backed-by-abbvie-but-cancer-i-o-biotech-tizona-targeted-by-gilead

Well we really need good results as we need a partner to take it to stage 2/3. Data so far and the preclinical data suggest it’ll do what it’s supposed to. It’s not just the actual value of 201 prostate. It would also demonstrate that Val can live up to the business model investors will have confidence they can deliver. We’ll obviously then have the upfront payment to secure the business financially to deliver the other indications from 201. Like endometriosis, ovarian and breast cancer, a lot of the safety data can be used from the first trial but some early trialling will be necessary as the other 3 indications are for females.

I’d be a bit disappoint with an upfront payment under 100m.

Even if this treatment has the same efficacy as the market leader it will be much more valuable as there are no side effects to deal with. As there’s no side effects the drug could be given on day one of diagnosis where as now they just wait and watch then they may use hormone therapy which has not very nice side effects.

If 201 is more efficacious and stops or slows metastatic spread it’ll be worth a fortune as every patient will want it

Only the mm’s knows who’s buying or selling and only they know if it’s a buy or a sell they are all guesses based on the trade price.

Yes and the price then was 8.25p. I’d be gutted.

If the 201 results are great which I have no reason to believe they don’t given the 4mgkg dosing from years ago and we’ve been at 8-16 for years with no data we could see an upfront payment way beyond our current value and that would be for prostate alone. There’s also endometriosis (301), breast and ovarian cancer. Prostate was chosen as there’s an unmet clinical need so the path way though trials can be speeded up.

They will have some kind of idea it’s doing what it supposed to do but won’t have verified results they can release.

Not if it’s bad news mate.

The global market for Prostate is 9.3 billion, if 201 works and we get 0.1% of that market it will be 1.5 x higher than our Mcap. Given the non-existent side effects of 201 I suspect the market share would be much larger.