Theratechnologies Inc T.TH

Alternate Symbol(s): THTX

Healthcare Biotechnology

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.

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Theratechnologies Inc > Amendment to trial design

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Comment by qwerty22on Apr 16, 2022 12:33pm

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Post# 34607568

RE:RE:RE:RE:Amendment to trial design

CRO - contract research organization

Wino115 wrote: That NCI update likely means they got no further questions back from the FDA like they stated, so it's all a go for the basket trial. Have to assume many of the additional details are based on what they and the investigators have learned thus far. JFM should like the fac they've added a number of exclusions to control the entry types even further which theoretically should provide the "right" kind of patients as oppposed to the "all-comers" in part 1.

I would not be surprised to see the PPM guys (the contract company I think, or maybe PPP) add some European sites as Paul said they would expand the basket trial to more sites in US and Europe. But this is the clearest sign yet that come end of May they'll be on to part 2.

qwerty22 wrote:
The thing I think I heard Christian sorta mumbled at the financial year report in Feb was that the 3 AEs in the 420 group which were on top of the neutropenia DLT were all the type of side effects seen with docetaxel. It's so vague and they've used up all their trust points with me so who knows exactly what that means. I guess it all comes down to manageability.

jfm1330 wrote: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4677113/