RE:RE:RE:RE:RE:RE:On the positive side Breast Cancer Clinical Trial: TH1902 in Patients With Advanced Solid Tumors
Breast Cancer Clinical Trial: TH1902 in Patients With Advanced Solid Tumors
https://www.centerwatch.com/clinical-trials/listings/270506/th1902-in-patients-with-advanced-solid-tumors/
TH1902 for Prostate Cancer Clinical Trial 2022 | Power
From the transcript last Quarter:
Paul Levesque
“And according to what we're going to see since we have a fast track designation, should we see back-to-back efficacy in one cancer or tumor, we will strategize and interact with the agency to see how we can accelerate the development of our compounds for at least one indication.”
Point is the first step is enrolling certain patient groups for the selected cancers sick enough to be eligible yet well enough to complete the study, all the above sites started appearing in the last few weeks so they are trying hard to enrol those 70 patients and I won’t be surprised if more sites starting advertising in order to speed up the enrolment. As for two consecutive efficacy results it was clearly mentioned by Paul. They can’t force the results but they seem to effectively trying to get those patients and they are as positive as one can except.
Today’s call:
“Christian Marsolais
I do believe that based on all of the [indiscernible] data that we have done and based on the patients selected, which is based on the high expression of the sortilin receptor that we should see sign of efficacy in some of those tumor types.”
SPCEO1 wrote: Those are all good points, as usual Qwerty. But wouldn't it be nice if the company helped non-clincial people, like almost all of their shareholders are, understand these things well in advance. Have you seen any attempt by TH to help investors better understand these intracacies so that expectations about data being available are contained in a relevant time frame.
Since TH does not do this very well at all, please feel free to fill in for them and warn us early when we are getting ahead of reality with posts like this.
qwerty22 wrote: We are all reading tea leaves. My preference is to have all shades from optimistic to pessimistic and draw your own conclusions from the mix. We have have some brains here, we all mostly take responsibiliy for are own actions, with a few notable exceptions. I think if we are getting dragged into somebody else optimistic reading of the leaves that our own fault. I appreciate what SPCEO does because he looks at things from a different perspective to me and that does shine a light on things I'd probably never think about. That's helpful.
Having said that there are some things on the clinical front that he says that grate with me such as :-
1) There is some relevance to patients reaching 12 weeks (i.e. two scans) as this is the earliest possibly moment they can be counted as 'confirmed responders'. But it should be noted strongly that is the earliest possibly moment. If a patient doesn't hit 30% tumour shrinkage in 1st scan (let's say -25%), then hits >30% in 2nd scan we are waiting for 3rd scan before they become confirmed responders. There is no necessity for patients to convert to confirmed responders by 12 weeks. Some should, my general understanding is chemo generates fast response, but to expect all your responder to come that quick is putting too high expectations. If you are not registering as a confirmed responder by 12 weeks then it's a long wait to 18 weeks for that to happen. Just as an example, no idea if this is realistic but let's say a patient is 25% shrinkage on 1st scan, 50% shrinkage on 2nd scan and 75% shrinkage on 3rd scan. In the final tally they are an excellent responder, at 12 weeks they can't be any more than a real hope. We have to still give this time to mature.
2) I also think his enrolment numbers were aggressive. I think 10-12 patients having their 2nd scan by now, 10-12 having one so far and 10-12 still yet to reach 1st scan.
If you dialled expectation back to there then they could have a mixed picture by now. 1+ confirmed responders, 1+ unconfirmed responders, Several SD patients with <30% tumour shrinkage. All that might not be enough for a meaningful readout. Something to alleviate nerves but not material, nothing more than exactly what we saw in 1a. But that might be enough to think they will eventually hit those all important benchmarks. Just not yet.
I think to some extent what SPCEO has done is pile one best case scenario (confirmed response by 12 weeks) on another best case scenario for recruitment and expected that to hit the mark now.
palinc2000 wrote:
Maybe just maybe you should stop reading tea leaves in every thing the Company does or wtites or says... Of course they think they have the key otherwhse why would they spend time and money on a Phase 1 trial?
The way to interpret the KEY comment is as follows
We think we have the key and we hope that the data ftom the ongoing and future clinical trial(s) will confirm that thought.....
Instead of that you elected to imagine that they were seeing positive results and so on..
You keep repeating the same imaginary expectations over and over
Hoping is ok but expecting imaginary outcomes based on giving different meanings to words or statements is a recipe for deception.
There were very little negative in today s report ...
The sales are showing good growth after decades of stagnation
, Phase 1 B trial is ongoing
Recruitment appears to be slow but Marsolais still expects to fully recruit within the original timeline
China partnering discussions still ongoing
Renewed interest in Nash and still talking to partners
The negatives are few -F8 only FIrst Quarter 2024
Of course those like you expecting great news on Th 1902 are disappointed ....
On my side I turned from neutral to slghtly positive on Th1902 a few months ago but very realistic about the possible outcome .
SPCEO1 wrote: I am not really a moody person but I will admit to being disappointed today. TH has long had a credibility problem, not so much because they consistently and intentionally do things wrong but because they are really poor at managing expectations. For example, why speak at the Cantor conference and talk about having the key to cancer cells, then post that comment online in several places so it is not missed and do so at a point in the phase 1b where TH should have data accumulating to make such a claim thus investors think you are actively hinting at good news, and then say nothing about keys to the cancer cell or almost anything else new about cancer in the call today? Why build investor expectations just to dash them on the rocks shortly afterward? And especially why do that when you have historically done similar things and are looking to change your reputation for doing so?
Bucknelly21 wrote: Hes not in a bad mood. As its legitimately concerning how the call was today. No one gives a rip about trogarzo, and every cancer question was evaded. Days after you thought you had the key. How can you have the key when you have barely reached 50% enrollment. Im sure this one isnt on paul either...hes a good talker but his honesty imo is in question