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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. It blocks viral entry into host cells while preserving normal immunologic function. The Company is also investigating an intramuscular method of administration of Trogarzo. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy.


TSX:TH - Post by User

Comment by scarlet1967on Jun 27, 2021 9:16am
126 Views
Post# 33457316

RE:RE:Dose escalation diagram

RE:RE:Dose escalation diagram

The diagram is the normal process of dose escalation, it doesn't cover the first two or more dosing of single patients each doubling the dose until DLT is observed, I posted the below earlier which explains the diagram.

"What I say is they treat one patient per dose level maximum 2 patients until one patient shows DLT or two patients show grade 2 toxicity during first course of treatment then the plan switches to classic 3+3, 3 to 6 patients are treated in each group. Three patients are then dosed with a dose level just below first one or two patients and are observed for toxicity, if none of three experience DLT, then next 3 group of patient are dosed at next higher dose, if 2 or more of these patients show DLT, three more patients are treated at next lower dose unless 6 patient have already been treated at that dose. If one of three patients treated at that dose shows DLT then three more patients are treated at the same dose, if one patient shows DLT among these 6 patients then next cohorts are treated at next higher dose, at that point if two or more of the six patients treated at a dose level experience DLT, then the MTD is considered to have been exceeded, and three more patients are treated at the next lower dose.

The idea of accelerated titration designs is not to treat patient at sub therapeutic levels, another benefit is the phase 1 takes shorter time specifically when the dosing starts at levels far below the MTD. It is in their trial design’s description, it makes sense to use this method for the above reasons. They would not put it in the trial description if that wasn’t the case. Anyway this my take could be wrong, but I doubt it."



SPCEO1 wrote: Are you planning on telling us what trial this diagram is from and why you posted it?

jeffm34 wrote:




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