“You mean the one that should have been filed at
Post# of 154635
(Total Views: 679)
Posted On: 12/23/2020 12:49:18 AM
“You mean the one that should have been filed at 525mg but the FDA screwed Cytodyn on that.”
Here’s my question in regards to the statement above: where’s the completed phase 3 trial data for the 525mg dose in CCR5-tropic HIV-1 patients who had documented resistance to at least two antiretroviral (ARV) drug classes? The answer is that the data doesn’t exist because a combo trial for 525mg wasn’t conducted, only a 350mg Combo trial was completed. It seems unlikely that CYDY ever had the opportunity to file a 525mg BLA.
Yes, there are 150 or so patients in the monotherapy trial that were/are on the 525mg dose for 48 weeks (or more), but that trial was designed for monotherapy, not for MDR combo therapy. Here’s the trial design statement for the monotherapy trial, “This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry.” The combo therapy trial was specifically for therapy MDR patients, who likely aren’t clinically stable if they’re shifting to a third like therapy, so I doubt the data from the 525mg patients in the mono therapy trial can submitted as part of the combo trial.
Here’s my question in regards to the statement above: where’s the completed phase 3 trial data for the 525mg dose in CCR5-tropic HIV-1 patients who had documented resistance to at least two antiretroviral (ARV) drug classes? The answer is that the data doesn’t exist because a combo trial for 525mg wasn’t conducted, only a 350mg Combo trial was completed. It seems unlikely that CYDY ever had the opportunity to file a 525mg BLA.
Yes, there are 150 or so patients in the monotherapy trial that were/are on the 525mg dose for 48 weeks (or more), but that trial was designed for monotherapy, not for MDR combo therapy. Here’s the trial design statement for the monotherapy trial, “This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry.” The combo therapy trial was specifically for therapy MDR patients, who likely aren’t clinically stable if they’re shifting to a third like therapy, so I doubt the data from the 525mg patients in the mono therapy trial can submitted as part of the combo trial.
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