Theratechnologies Inc T.TH

Cancer phase 1 expectations

[jeffm34]

I think we have to temper expectations of efficacy in the phase 1 trial.  They are enrolling patients with no other options left so their prognosis is very poor.  Success in this trial will be if TH1902 is no more toxic than docetaxel alone.  If there are no significant signs of efficacy, it is not necessarily a failure.  If there is significant efficacy in this patient population it would be pretty amazing to say the least. 

The phase 1 study will comprise dose-escalation and dose-expansion portions.7 Patients have to have recurrent advanced solid tumors, have relapsed on or be refractory to standard chemotherapy, surgery, and radiation, and have no effective alternative treatment options to be eligible for the first-in-human study of TH1902.

[juniper88]

Yes, phase I is about safety. But if TH-1902 doesn't show efficacy in this population it won't show efficacy in a less treated population. Sortilin expression increases as the disease progresses. This is how TH-1902 is very different from other treatments.

[Wino115]

It will be interesting to see if the dosage study portion ultimately winds up at a much larger equivalent dosage of what they can do in plain docetaxel.  That's what some of their previous studies showed. I believe someone calculated it could be up to 20x more on an equivalent basis. So you can prove you are getting more of the chemo right into the tumor, and if SAEs are low, we'd

[qwerty22]

There is an efficacy hypothesis they are testing here. The reason these patients have no options is in part because their cancer has become resistant to drugs. The hypothesis is that th1902 bypasses some of the resistance mechanisms by delivering the drug into the cell in a new way. So if the drug is going to work it should work on some of these optionless patients. I think therefore you can be a