it looks as though they’ve created a 3rd generation AR now.For when Aberaterone / Enzalutamide runs out of steam.
Can a drug be fast tracked onto the market at a 3 year point or do the trials need at least 5 years before being approved does anyone know
It needs to prove safety and efficacy vs standard-of-care. After Phase 1 (dose, safety) and Phase 2 (effectiveness on a limited sample - usually just PSA reduction), most drugs are ruled out. In Phase 3 testing, men who are castration-resistant after a second generation hormonal will have to be randomized (and blinded) to that drug vs SOC. After half the men in SOC die, they can assess if the new drug improved survival. Sometimes they will allow a surrogate endpoint like radiographic progression-free survival instead of overall survival, which takes less time to demonstrate.
thank you
Any estimate on the time to get through this process and get FDA approval, TA?
Nice article, albeit highly technical, on AR antagonists and novel compounds under investigation.
I am heartened by this research as it is attributed to Johann de Bono in London who is a top researcher in our disease and participated in the earliest and the continuing trials of Abiraterone, among others. If he has chosen this drug, or if the company has chosen him, it signals it has real promise as his trial schedule is limited.
I followed him during the abiraterone studies which is how I recognize his name.
Yes it’s also mentioned by Karim Fizazi (he of peace 1) and they really thought it was going to turn this disease into a Chronic disease in conversation with Johann de Bonno with inference that it could resensetise the ADT .
Just got to hang around long enough to be able to benefit from it.
Karim Fizazi at L'Hopital Villejuif near Paris is another on the level with de Bono. If one sees either name, read closely and pay attention.
I believe this is the drug being talked about and sounds promising. Already in phase I (at least 2 years ago), and I also read may be used as a single treatment option...assuming it works as planned.
cellcentric.com/updates/blo...
In vivo pharmacokinetic studies showed the chemical series to be orally bioavailable with low to moderate plasma clearance across several species. Profiling the best compounds in mouse xenograft studies of late stage prostate cancer (models in which current marketed agents fail to work) indicated excellent tumour growth inhibition with complete tumour stasis achievable at well tolerated doses.
CCS1477 is currently in Phase 1 clinical studies for the treatment of late stage, castration resistant prostate cancer, as well as more recently, in a parallel study evaluating the treatment of certain haematological malignancies (multiple myeloma, non-Hodgkin’s lymphoma and acute myeloid leukaemia). Longer term, it can be applied to cancers with certain specific genetic drivers.
cancerresearchuk.org/about-...
Recruitment start: 20/06/2018
Recruitment end: 30/09/2023
yes that’s it
Hormone therapy for the older generation
Stem-like cells and transcription to AR-
AR-V7, Zytiga(abiraterone) and Xtandi (enzalutamide)
Depression from 2nd-generation hormone therapy is worse
