Theratechnologies Inc T.TH

“Low dose docetaxel”

[qwerty22]

So I went back to an idea I had when the 1a info was released regarding the issue with free docetaxel from the small portion of degraded drug. Can't believe it took me this long to google "low dose docetaxel" tbh. Anyway there's been preclinical and clinical work in this area. One study stands out. It uses 20mg/mm3 weekly for 3 weeks only in a palliative setting. I don't think they are bothering with scanning tumours at this stage. It uses PSA as a biomarker response and is looking at QoL issues for peoples final months. They report close to 50% see a reduction in PSA and there's an improvement in QoL, there was some duration to these response (mean 5 months). That's pointing to biological activity at low doses, this was in patients who'd already failed all options. I think generally there is less free Docetaxel in THTX's patients than these studies but it can't be ruled out that there's some effect here, both the PSA and even the prolonged Stable Disease patients might at least fall into this category. IDK about the 50% tumour reduction patient.

I'm back to worrying about the role of the "free docetaxel" in THTX's patients. Going with JFM's point that they've given us a headline piece of info on % degraded drug which is difficult to put into context, we need drug exposure numbers, it's difficult to say what role the free docetaxel is playing. The 50% tumour reduction seems robust, shame that patient dropped out for other reasons.

I guess the point I'm making is they need something more robust coming from 1b to show this drug is raising it's head above the backgroun$ noise you might see. Initially I thought one strength of this trial is it's a one drug trial, now we really need to at least rule in the idea that this is in fact a combo trial of th1902 and very low dose docetaxel. They can't just dribble out the odd PR patient and PSA responder and expect it to move the story along. So they have to hit milestones like whatever the nex5 go/no-go signal is. Probably no point in releasing news unless it reaches a particular benchmark.

https://pubmed.ncbi.nlm.nih.gov/12759524/

Maybe this is more nailing for me why they are still far from calling PoC atm, lot's of uncertainties still here. I'm not against SPCEO's calling a lot of positive signs but still something to prove.

[realitycheck4u]

This post has been removed in accordance with Community Policy

[qwerty22]

We don't have zilch, we have uncertainty. We have a problem of assigning the efficacy to drug being shuttled into the cell via Sortilin because we essentially have low levels of a second drug floating around in the blood. It matters while the efficacy evidence is thin. It probably doesn't change the long term needs much though. The drug still needs to get enough responders to raise it'

[Joemare]

Agree with unceertainty.  Ideally, a PII comparing newly diagnosed patientes randomized to docetaxel alone vs. docetaxel +1902, in one cancer type, with three different levels of sortilin expression.  See response rate as primary end-point, progression free survival and overall survival as secondary end-points.   Unfortunately, we are definately not there.... FDA and any

[qwerty22]

They'll never get to test this on newly diagnosed patients. Imagine the scenario, you get diagnosed with cancer, it might kill you. do you want. a) A drug that's shown to work. or b) An experimental drug that might work. They are stuck with people that have tried pre-existing drugs until they have proven this out, that means at least first approval.  

[PWIB123]

I thought these things were already understood and the whole idea is not that docetaxel isn't effective, but that docetaxel on TH-1901 is more powerful without increasing side effects or safety issues.  I'm not a scientist, but it wouldn't make sense to me based on what we've heard so far that free docetaxel would be contributing to the improvement after a larger dose. 

[palinc2000]

I dont know why some are expecting great news coming out of a Quarterly CC...They will provide some updates but no trial results on Thursday   ..Any trial results would be released separately  ahead of or subsequent to a Quarterly Financial Release.  I think it is fair to say that most early trials show some positive signs but those signs need to be confirmed by hard data

[palinc2000]

I am of the opinion that the SP can still rise ahead of trial results if oncology experts weigh in when they see enough signs that there is a chance of positive results...We have not seen that yet,,,,If that happens the SP will rise with no news

[Biobob]

Twice to 12$ on no news in the early 2000s... never know what opportunity window we might get to rebalance our portfolios..... 

[Bucknelly21]

Do you know of any experts that are paying attention?

[palinc2000]

I dont know any of  them but I am quite certain that oncology  analysts of major brokerage houses have consulted with their in house experts and obviously the enthusiasm has been close to zero The incentive to be the first or amongst the first to take a position in a disruptive technology with  the potential for once in a lifetime return is the dream of every analyst...Yet nobody

[Wino115]

"Not enough meat on the bone" is right. My experience is that (other than deal broker analysts), the biotech and oncology specialist analysts are generally more than happy to wait until there's a Phase 2. I think it's fairly rare to stick your neck out on a new, unknown technology. The guys I follow love to see way more data that has been released thus far to understand the

[scarlet1967]

This is more updated version in terms of treatments for Prostate cancer, apart from surgery, radiotherapy, focal therapy. systematic treatment including among others hormone therapy as androgens(male hormones are responsible for the growth of the cancer), immunotherapy, chemotherapy or combinations of them for stage 1, 2, 3 cancers. As for stage 4 when the cancer start spreading to other organs

[scarlet1967]

I highlighted the part about consideration of looking for suitable clinical trials as the prognosis of remaining options can't be promising! "Metastatic castration-resistant prostate cancer (updated 09/2022) If the cancer is no longer stopped by low testosterone levels (less than 50 ng/mL) and has spread to other parts of the body, it is called “metastatic castration-resistant

[Biobob]

I'm expecting a deception in regards to the sales that will be below conscensus as always, then I expect the number of patient recuited up to now in th ebasquet trial  will be too low and behind schedule and finally I will be left in the dark in regard to POC once again and wondering what the heck just happened.. nothing and then the fear of the unknowned will be back in my gut. So Th

[qwerty22]

I generally agree with your sentiment but I don't know exactly what you think going to Ph2 means. I'm not sure getting the first 10 in each cancer get's us to move on to a new phase. The seamless nature of the oncology process makes the phases somewhat obsolete. I tend to think exploratory and conformational (or registrational). I see us in exploratory for a year or two more while they

[palinc2000]

In my mind the go- no go decision will be made based on observations during Phase 1 b and going into phase 2 would mean that they think that POC has been reached,,,,But I dont consider POC as the end game of course .... I am not saying that I am right but I think there is a need for some here to ne more realistic about expectations particularly short term expectations

[Biobob]

At the moment the market is pricing nothing.. Th1902 is worth nothing... so expectations are for nothing.  They only need to become one of the 45 other Fast track companies in Onco... anything that points to that will be worth more than the Chocolate bar money we have atm...

[Lee430]

Actualy one share of Thera could not even get you a bag on Chetos right now ;-<

[Biobob]

Check Walmart.... HERSHEY'S Creamy Milk Chocolate Family Size Bar Hershey's 100g   (47) $1.98    Price is measured as$1.98/100g    

[Wino115]

I believe it was 45 drugs, not companies got fast tracked in 2020.  Not all are for cancer either. That would be a smaller number.  On this low dose dox talk - if the drug works, it's killing tumor cells rather effectively. Given dox would not have worked on it's own to kill the tumor and metastices off, it should be clear what's doing it.  I even wonder if in these

[jfm1330]

I don't know how often I will have to repeat it, it is not clear what this 11% of free docetaxel value they published mean. Is it AUC (area under the curve) which qhantifies the total docetaxel released in the blood stream over time or is it Cmax, which is maximum concentration of docetaxel reached in the bloodstream after injection. If it's AUC, it is unlikely that it would generate

[qwerty22]

The paper I linked to was for palliative patients who had been through everything so you could say equal to or one step beyond THTX's patients. They were seeing clinically meaningful effect, PSA is a validate biomarker. They were getting 20mg/mm3 WEEKLY, THTX are seeing the equivalent of 8mg/mm3 (?) (it is very odd how they word this). These palliative patients are receiving more DOC but it