This article needs to be updated. (May 2024) |
Remune was the first therapeutic HIV vaccine based on the killed whole virus approach. Remune was initially invented by Jonas Salk in 1987 and was developed by Immune Response BioPharma, Inc. (IRBP) [1]
Remune is a therapeutic HIV/AIDS vaccine that has completed over 25 clinical studies to date and shows a robust mechanism of action restoring white blood cell counts in CD4 and CD8 T cells by reducing viral load and increasing immunity.
The FDA is currently reviewing IRBP's BLA (biologics licensing application) for therapeutic treatment in people with HIV. Once the FDA approves the BLA, Remune will be the first therapeutic HIV vaccine brought to market.[2]
IRBP is set to submit its BLA with the FDA in early 2014. REMUNE granted FDA Pediatric Orphan Designation on Feb 14th 2014.[3]
Vaccine design
editRemune is made of beta-propiolactone inactive HIV-1 which has been irradiated to destroy the viral genome. The vaccine, however, does not contain gp120 surface antigen as it falls off on fixation of HIV-1.
As a result, only gp41 is remaining on the virion surface. The initial clinical trial demonstrated a significant difference in clinical benefit between Remune vaccine and placebo with a decline in viral load P < 0.05 & HIV-1 lymphocyte proliferation P < 0.001 both favoring the Remune Group.[4]
The International AIDS Vaccine Research (IAVA) issued a report on "Whole Killed AIDS Vaccines" in 1999 reviewing a diverse aspect of the killed virus approach.[5][
Outcome
editTrials of Remune have largely shown no benefit. Immune Response Corporation (IRC), one of the developers of Remune, tried unsuccessfully to block negative research findings. Pfizer pulled out of its partnership with IRC and there is now doubt about any further development of Remune.[6]
References
edit- ^ Immune Response BioPharma, Inc
- ^ http://www.prlog.org/12440202-immune-response-biopharma-inc-announces-the-fda-has-accepted-remune-hivaids-vaccine-bla-for-review.html
- ^ "Search Orphan Drug Designations and Approvals". www.accessdata.fda.gov. Retrieved 2015-05-19.
- ^ Turner, Jl (2001). "The effects of an HIV-1 immunogen (Remune) on viral load, CD4 cell counts and HIV-specific immunity in a double-blind, randomized, adjuvant-controlled subset study in HIV infected subjects regardless of concomitant antiviral drugs". HIV Medicine. 2 (2): 68–77. doi:10.1046/j.1468-1293.2001.00051.x. PMID 11737381.
- ^ IAVI Report on Whole Killed AIDS Vaccines
- ^ Remune Bites the Dust ... Again by Enid Vazquez.