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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. 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. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.


TSX:TH - Post by User

Post by qwerty22on Aug 06, 2021 7:18am
242 Views
Post# 33662362

MTD and the FDA

MTD and the FDAScarlett brought this news to the board about the fda seeking alternatives to MTD.

https://www.fiercebiotech.com/biotech/fda-s-renewed-focus-oncology-dosing-spooks-investors-but-companies-say-they-were-ready

It got me thinking about how thtx might handle this (if they had to), I'm not suggesting they have to atm. Anyway it's pretty well known how normal docetaxel accumulates in tumours. You can use that concentration as your target concentration for dosing. So rather than rely on MTD to find the maximum dose based on  safety you use a tumour accumulation number to get a dose based on efficacy. You can only do this because you have the long experience of using docetaxel in patients. I'm not saying this is what they'll do, to me it's just another example of how it might help the drug development process to be using an old, well-understood chemo.

Hopefully they get tumour material and are able to measure drug (and released docetaxel) in the tumour. It will be a good number to have for many reasons. If investors were truly spooked by the FDA's shift from MTD, it would be good for thtx to have a pre-prepared solution.


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