||This article needs to be updated. (June 2016)|
|Source||Humanized (from mouse)|
|intravenous (IV) injection|
|(what is this?)|
Ibalizumab (TMB-355 previously known as TNX-355) is a non-immunosuppressive monoclonal antibody that binds CD4, the primary receptor for HIV, and inhibits the viral entry process. It is being investigated as an HIV entry inhibitor with the ability to block both CCR5- and CXCR4-tropic viruses, and is undergoing a Phase II clinical trial with an estimated study completion date in December 2010. Specific Research is also conducted at the Aaron Diamond AIDS Research Center under the direction of David Ho.
Results from a previous Phase II of ibalizumab, reported by the original developer Tanox in 2006, showed that persons with HIV who received the drug, in combination with an optimized background regimen (OBR), maintained a considerably greater reduction in viral load and experienced a statistically significant increase in CD4+ cells than did patients given placebo in combination with OBR. Thus, pending results of further trials, it is one of a limited number of viable alternative strategies to contain the virus without recourse to antiretroviral drug cocktails or a vaccine.
Ibalizumab is being developed by TaiMed Biologics but was first developed by Tanox, now part of Genentech. As part of Genentech's takeover of Tanox, the patent for ibalizumab was sold to TaiMed Biologics, a biotech company formed in 2007 with support from the Taiwanese Government through a $20 million investment by the state-owned National Development Fund.
- 2003: completed a phase-1a clinical trial for i.v. infusion dosage form.
- 2003: granted fast track status by U.S. FDA.
- 2003: completed a phase-1b clinical trial for i.v. infusion dosage form.
- 2006: completed a phase-2a clinical trial for i.v. infusion dosage form.
- 2011: completed a phase-2b clinical trial for i.v. infusion dosage form.
- 2012: completed a phase-1 clinical trial for s.c. injection dosage form.
- 2013: initiated a phase-1/2 clinical trial for s.c. and i.m. injection dosage forms (on-going).
- 2014: granted orphan drug designation for HIV MDR patients by U.S. FDA.
- 2015: granted breakthrough therapy designation for i.v. infusion dosage form by U.S. FDA.
- 2015: initiated a phase-3 clinical trial for i.v. infusion dosage form (on-going).
- 2016: initiated and intended to complete a rolling BLA submission for i.v. infusion dosage form to U.S. FDA.
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- Jacobson JM, Kuritzkes DR, Godofsky E, et al. (February 2009). "Safety, Pharmacokinetics, and Antiretroviral Activity of Multiple Doses of Ibalizumab (formerly TNX-355), an Anti-CD4 Monoclonal Antibody, in Human Immunodeficiency Virus Type 1-Infected Adults". Antimicrob. Agents Chemother. 53 (2): 450–7. PMC . PMID 19015347. doi:10.1128/AAC.00942-08.
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- "Dose-Response Study of Ibalizumab + OBR in Patients With HIV-1". ClinicalTrials.gov. 2008-10-30.
- Park, Alice (2010-01-25). "David Ho: The Man Who Could Beat AIDS". Time. Retrieved 2010-05-04.
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- TaiMed - TMB-355 - Pipeline