RE:RE:RE:RE:RE:RE:RE:Insider buying Just to add another opinion (which I am guessing at), I had always interpreted their vague reference to 1b having a clearer picture around cancers that overexpress sortiline and not "all-comers" as meaning they were going by past academic evidence. In other words, the field research shows that for TNBC and melanoma, 90% of advanced cancers overexpress sortilin1. So those cancers are in the basket. For colorectal, it's at the low end --40%, so they are now excluding or limiting those patients to a much smaller number. So while they aren't going to be determining a cutoff or perhaps even doing any staining prior to enrollment (but maybe afterwards), they are just going with the statistics on which to add in to the basket trial in larger numbers. I suppose for P2, they can refine this even further if need be.
I think you all are correct on the fact they probably won't get any of the 4-5 lead doctors starting 1b enrollment, what I had assumed they meant when talking about preparing to immediately go in to the basket trial was just that they were doing all the behind the scenes things you need to do. Recall PL a few times mentioned they would be doing the basket and Phase 2 in both US and Europe and would open more centers. I just interpreted this to mean they are working with PPD (the contract collaborator) to ready more centers and all the back lab support needed to expand the trial to 3-4x as many patients and hopefully 2-3x as many sites. There's probably a lot of behind the scenes prep you need to do in order to state that you will go immediately from a dosage trial to a larger basket trial in multiple regions. All this is just my guess and I could be completely wrong!
scarlet1967 wrote: It's safe to say they will be screening for sortilin whatever procedure is involved but I can see the complexities you mentioned as for being ethical or not some trials have a waiting list and here in Canada from diagnosis to treatment it can take a good 2 or 3 months that's just sad reality.
[iquote=qwerty22]
https://clinicaltrials.gov/ct2/show/NCT04706962
First off there is no evidence they will be screening for Sortilin yet. It's still not in the inclusion/exclusion criteria and there is no protocol by which to screen. There are lots of practical reasons for this but one thing you need to nail down is a cutoff point, that's to say the level of staining required to include/exclude a patient. They have no cutoff point. They can't generate a cutoff point based on the small number of patients they've treated so far. I guess you think if the have no staining then there's no Sortilin but for practical technical reasons you can't assume that, that is one of the weaknesses of immunostaining. You have to define a cutoff point by first enrolling a good number of patients and looking for a relationship that means still not screening yet.
I get the point you are making about getting patients on the books ready for the start.But these are human beings in the last chance saloon. You don't enrol in a trial that is not up and running. You can't say wait a few weeks and hopefully the trial will start, that's unethical. If these people want to get on trials then they want to do it now and they will look for trials that have already started. What you are suggesting is just not done. I think you are mis-reading statements about recruiting. Most likely that was to do with the final patients in 1a. Clinical staff at the sites can get ready for sure, I just don't believe ANYTHING can be done with patients until 1b formally starts and that's clearly when MTD/RP2D has been determined.
scarlet1967 wrote:
From the transcript!
Paul:
“Now, if the absence of dose-limiting toxicity or DLT is confirmed at 300-milligram per square meter, this dose will become the recommended Phase 2 dose. As previously discussed, once the recommended Phase 2 dose is established, initiation of enrollment of the larger open label basket trial will begin immediately, which can potentially start as early as the end of May.”
Christian:
“As you know, it's sometimes difficult because patients are advanced, but we do think that those three patients will be treated in April. Then three weeks after that, the cycle will be completed. And if there are no DLT, and based on the experience that we have with the drug so far, we're confident that there should not be any DLT at 300, we will be ready to initiate the basket trial, which should be towards the end of May - of this certified question.”
As per the trial design:
“The dose selection for Part 2 of this study will be based on the MTD and other available data. Once the MTD has been determined in Part 1, patients in Part 2 will be treated at the immediate dose level below the MTD, to further assess the safety and tolerability of TH1902 and the preliminary anti-tumor activity of TH1902.”
I don’t think they would start the 1b before finalizing the 1a based on their plan and the clinical trial’s description because they need to have the MTD and “other available data”.
Would the expansion part start before end of the May? I don’t know and I don’t think they know but that’s their plan now the fact that MDA started recruiting the 70 patients to me is a sign that they want to get the ball rolling without any delays between the 1a and 1b, we are talking about finding 70 patients and then the screening for sortilin etc. Good to see a proactive approach!
https://www.centerwatch.com/clinical-trials/listings/270506/th1902-in-patients-with-advanced-solid-tumors/
qwerty22 wrote:
I don't believe they've started 1b yet. Those last 6 patients (and their data) are either necessary to start the expansion phase or they aren't. If they aren't then they wouldn't enrol them and we'd already be in 1b. If they are necessary then it's necessary to wait for them to complete their cycles and give up their data. I don't see the two things overlapping.
We should just take that their INTENTION is for the expansion phase to begin asap once 1a is complete and to that timetable. Whether it does depends on how the last enrolments go, not something they can have complete control over.
scarlet1967 wrote: They said the final group of patients will be dosed in the beginning of the April the cycle takes 3 weeks and then they take the usual 3 or so weeks to analyze the results so I wouldn't expect any announcements for another 2 or 3 weeks. They also said the phase 2b will start before end of May and as previously posted they have started recruiting(70 patients).
But I agree he not only took advantage of the price action but also while we are waiting for the news it's good to see any buying just before any announcements.
SPCEO1 wrote: Since an insider was able to buy during the margin call incited brief sell-off in the stock today, that likely tells us the news on the phase 1a is not coming until the end of May at the earliest. I am not sure how far ahead of such an announcement insiders have to stop trading but it may be a considerable period of time.
I like that board member Arena wasted no time in getting his filiing in so other investors could quickly get the message there was nothing wrong with the phase 1a or THTX generally.
scarlet1967 wrote: -
May 02, 2022 (filed on May 02, 2022)
Insider Name:
Arena, Joseph
Ownership Type:
Direct Ownership
Securities:
Common Shares
Nature of Transaction:
10 - Acquisition or disposition in the public market
# or value acquired/disposed of:
4,900
-
May 02, 2022 (filed on May 02, 2022)
Insider Name:
Arena, Joseph
Ownership Type:
Direct Ownership
Securities:
Common Shares
Nature of Transaction:
10 - Acquisition or disposition in the public market
# or value acquired/disposed of:
100
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