Trial Profile
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 07 Nov 2022
Price :
$35
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At a glance
- Drugs Leronlimab (Primary) ; Antiretrovirals
- Indications HIV-1 infections
- Focus Registrational; Therapeutic Use
- Acronyms PRO140
- Sponsors CytoDyn
- 01 Dec 2021 According to a CytoDyn media release, the company has completed submission of all the major sections of CMC modules to the USA FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (FDA). Only the clinical section remains to be submitted.
- 16 Nov 2021 According to a CytoDyn media release, the company will file for expanded access use of leronlimab for a fee to MDR HIV patients who might need leronlimab urgently, possibly as soon as next week.
- 16 Nov 2021 According to a CytoDyn media release, the company has initiated the resubmission of its Biologics License Application for HIV under rolling review consistent with guidance from the U.S. FDA. The resubmission will include non-clinical and CMC sections during November, followed by submission of the clinical section in Q1 of 2022.