Theratechnologies Inc T.TH

Interview with Dr. Shah

[scarlet1967]

https://www.oncologytube.com/video/39866/satish-shah-md-sasmd777-gettysburgcancercenter-breastcancer-cancer-research-phase-1-clinical-trial-of-th1902-for-sortilin-positive-solid-tumors?channelName=cancernewsupdate

[qwerty22]

Very nice. He sounds enthusiastic.

[scarlet1967]

Patients young and old attend clinic 2 to 3 times for blood test etc some visits take 6 hours to check for side effects. The clip is one day old....

[Wino115]

I like that a practitioner refers to this as a "breakthrough" approach. He further equates the need of new therapies to "avoiding side effects".  I guess that is a very high desire for doctors to see.   Paraphrasing him -- Living a good life for the period he can control the disease with a treatment. This drug certainly fits the profile of what he's looking for.

[qwerty22]

I've definitely heard a lot of oncologists talk about cancer almost like a chronic, managed disease where extending life with QoL might be a target outcome rather than cure per se. This also seems to be a path to approval with the fda. So yes very nice very strong responses are desirable but an alternative (or addition) to that is clinical stability and tolerability.

[Wino115]

Interesting observation.  I also liked his reference to having a treatment for younger patients that exhibit refractory cancers because they have potentially so much more life ahead of them so, as you say, if you can manage it more and provide something measured in many years instead of many months and all with limited side effects, that's an amazing breakthrough.  We, and his

[palinc2000]

Very interesting interview! Will there be a PR or similar when the MTD will have been determined and will they share what the actual dose will be?

[scarlet1967]

I am hoping they would announce more details as the trial progresses for instance each escalation sequence and results etc.… I am not a clinical trial expert so I asked Spartrap about the timing going forward, it seems ideally(if everything goes fine) it can take about 6 months before a good number(highest possible dosage with no adverse effects as per planned) for the MTD is known so the longer

[palinc2000]

thx a lot.... very clear.... Is it 100% certain that the higher the MTD the higher the efficacy ? Or are there other factors to consider?

[scarlet1967]

The way I understand it the short answer is yes but for the technology to work there other pieces which needs to come together, obviously the whole PDC has to be stable in the blood for long time enough before it gets internalize into cancer cells otherwise there is high chance of toxicity and chemotherapeutic agent can induce neutropenia (lower blood cell and risk for infections), the other

[scarlet1967]

"Lower white blood cells".

[palinc2000]

  yes I know that the technology needs to work .... but would they necessarily consider the MTD as one size fits all for all the 4-5 different cancers and for all the patients or would /could they make ajustments per type of cancer, patient age and sex and weight etc....I am really trying to see if the duration of the trial can be  easily predictable or not

[scarlet1967]

I am not sure but I would guess generally speaking the demographics will also be considered during clinical trials as per the MTD it seems they will be trying to find it for few cancers. From the trial design: “Part 1 (dose escalation): will comprise patients with recurrent advanced solid tumors (all comers) that have relapsed or are refractory to standard chemotherapy, surgery, radiation

[scarlet1967]

I guess during phase 2 and beyond they will find out whether they need to adjust the MTD for different cancers or not again not specifically for safety but efficacy.

[jeffm34]

A starting dose of 30 mg/m2 is proposed based on the available data for TH1902 and the known safety profile of docetaxel.  It looks like the usual dose of docetaxel alone is 75mg/m2 

[scarlet1967]

That's the whole idea behind targeted drug delivery, lower dosage of anti cancer agent but directly delivered into cancer cells thus better therapeutic effects.

[qwerty22]

I read standard docetaxel is more like 100-125mg/m2, it can be higher, I think it varies with application.  

[scarlet1967]

The duration of the trial can't be easily predicted so early in the process, reason is it all depends on the ongoing results not only in phase 1 but the beyond for instance whether they need to increase or/and decrease the dosage to find a equilibrium in terms of safety and efficacy for each indication so it's all data driven imo, of course the fast track designation especially when they

[qwerty22]

I don't think the period required to find the MTD will vary all that much, maybe a couple of months at most, so it doesn't much affect the overall time of the trial. There are other aspects of the trial that are important to its overall time.

[qwerty22]

The thing is THERAPEUTIC WINDOW, Christian occasionally talks about that. That is how low the dose can go while still giving some measurable clinical benefit and how high the dose can go before the side effects become unmanageable or intolerable. The bigger that window is the more likely the drug can find a space to occupy in the therapeutic landscape. I would say there are a variety of different

[scarlet1967]

The way I get it the trial  will havd two shots on the target one lower adverse effects same efficacy thus better compliance( better quality of life) two acceptable adverse effects( possibly even more side effects) and much better efficacy as a trade off thus longer life expectancy.