George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
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I can remember someone stating some time ago we had some interest from Shire Pharmaceuticals (I may have this way off track so please forgive me) on 201, for some reason or another it didn’t materialise. Do you think on the cusp of 201 results there could be some renewed interest from them? Also just found Shire are now owned by Takeda (Jap Pharma) could they possibly the comp that have the MTA on 301 also? Again, thinking out loud here. Hope Suze and the crew are prepping that RNS on 201 data, I find the RNSs now so much more informative with less questions being asked after. Great platform now to build from. ATB :)
At this juncture, my friend, I will take my cap off to you. You have consistently pointed to the fact that there is an "unusual" heads-up regarding this test article. You've told people this time and time again, and you have been right and helpful to do this. If the next batch of results are "good" or above, I shall very much look forward to your entrance onto the stage that day. :-)
Fingers crossed you’ve got this one nailed saint
Ha ha, Saint-t and conservative in the same sentence, never thought I’d see that written on a bb.
So, in essence, and I never thought I'd type this, Saint Ts estimates are on the rather - ahem - conservative side. :-o Either way, if the results are even "good", the cash runway position shouldn't be an issue again.
I think the blood work was comprehensively expanded to add in all the variables to encapsulate what might be ordinarily generated later, say at Phase 2b. Basically, this has delayed this phase a bit, but I'd expect they'd now know where they have to be exposure, dose regimen, protocol, target postulation etc-wise, for the next stage. Someone asked about time. Depends on funding. Can expand to 2b over two years, Phase 3 same again, but very variable and likely longer in our situation, but in the window of this magnitude. Cost-wise; massive expansion of corporate sums paid in last 5 years, as the big players' in house capabilities have dried up in the main. Don't feel sorry for them, thought, they've raked it in on Coronavirus PR vaccine anticipation, so these acquisitions have become relatively low risk for them. Hard to place a figure; similar markets typically generation 500m in instalments up to Phase 1 commencement, with single digit royalties on release for IP transfer. But with these recent acquisitions, many are still early preclinical; this one is far, far, beyond that stage. So worth much more if sold rather than partnered. I favour the latter. And let's face it, it's such a worthwhile therapy area to be in, let's not lose sight of that.
Thanks for your summary ST, my question was more around, if this is ground breaking for cancer suffers how long could it take to make VAL201 as a treatment method for general public outside of these trial.
As an investor I am keen for the share price value to be maximised but also understand when suffers of cancer could benefit.
I am not sure if this time period is likely to be 1 - 5 years and interested in some views.
Hi Grace, thanks for your reply and hope you're enjoying your weekend.
On your point 1 where is the bit they missed the 5mg/kg patient?
I know this is probably a very difficult question to answer but could one of the experts comment on an estimated timescale for VAL201 to complete further phases and gain release to the general public. Obviously assuming that the results we hear in the next few days are positive.
Exactly...they didn’t change and tighten up all those criteria for no reason at all...
what do you make of the blood work criteria added in? To me it just seems that they were checking the patients were generally healthy enough to be able to withstand treatment for a prolonged period?!
Bob on there. What I find particularly insightful are the pre-treatment PSA criteria; pretty thorough and gives those interim results much more teeth that any prolongation was not by chance.
Just to point out, I know my second point doesn’t relate exactly to the wording of the criteria, as they have to include non castrate participants too...as the first part of the trial is still included. I was referencing that they have now been more specific in focussing on that aspect as a minimum, so will hopefully just now focus on the castrate resistant for the extended version
Yep! A few things I like about the updated criteria for the extended trial:
1) Average timeframe extended. Shows to me that it’s well tolerated at the increased doses, otherwise patients would have to be removed from the trial before the end of this period. Also extending the timeframe for collecting data may be viewed as a positive, in terms of the data being positive...so you generally carry on collecting if the drug is working and predicting positive results, due to the patient wanting to stay on the trial to continue the positive effects. Not explained very well, but it’s sunday morning...many other people explain things here more eloquently than me. Whatever happened to that 5mg/kg patient?!
2) criteria for rising PSA levels after castration resistance has now been established. Hopefully this means they have now focused on the castration resistant participants only for the extended results, as these are the ones our drug showed to be working the best for in the initial study. This is the group we want our drug to work in the best, as castration sensitive people still have other options as their cancer isn’t as far developed and hasn’t stopped responding to lowering androgens (mainly testosterone) yet. Castration resistant people, unfortunately, do not have other options as their cancer has developed into the final stage of now growing independently of being ‘fed’ by androgens.
3) General focus and tightening up of criteria to build upon the results of data already obtained in the first trial and further investigate areas of strength.
Hope everyone is having a good weekend.
It would really be incredible if they do pull it off with late stage cancers. The Ceo sounds upbeat and positively enough that we may be on the cusp of something ground breaking.. Here are three cheers to waving goodbye to ever being priced in pences next week hopefully..really excited to see what awaits next week. Gla
OMG, if they pull this through on incurable stage3/4 cases, then that would be an incredible result!
https://clinicaltrials.gov/ct2/history/NCT02280317?A=1&B=13&C=Side-by-Side#StudyPageTop
Eligibility:
Stage III Prostate Carcinoma
Stage IV Prostate Carcinoma
Inclusion criteria:
-Specific Inclusion Criteria for Patients with Prostate Cancer
-Patients with incurable, locally advanced or metastatic prostate cancer where a policy of intermittent hormone therapy has been decided. Who have specific clinical parameters.
-Specific Inclusion Criteria for Patients with Other Advanced Solid Tumours
-Patients with histologically and/or cytologically confirmed advanced solid tumour for whom no standard effective therapy is available and a rationale for use of VAL201 exists.
Patients with incurable, locally advanced or metastatic prostate cancer where a policy of intermittent hormone therapy has been decided. These patients must also have the following:
-Rising PSA on three samples (once non-castrate levels established); each over 2 weeks apart, with the last two values being greater than 2 ng/mL. Higher than and at least 25% over the nadir.
-Absent or very mild prostate cancer-related symptoms.
-No plans for any therapy for prostate cancer in the next two months.
Looks positive by the way in that they have trialled this for longer to assess it in depth.
Grace and any others on here, I found this on a gov website for VAL201 and its clinical study which completed in July 2020. Its more on the trial itself and criteria than results but worth a read. You will need to view it in a full browser to see any comparisons between what was initially envisaged and actual.
https://clinicaltrials.gov/ct2/history/NCT02280317?A=1&B=13&C=Side-by-Side#StudyPageTop