PRO 140
Encyclopedia
PRO 140 is a humanized
monoclonal antibody targeted against the CCR5
receptor found on T lymphocytes of the human immune system
. It is being investigated as a potential therapy in the treatment of HIV infection.
The United States Food and Drug Administration
has designated PRO 140 for fast-track approval
. In February 2008, the drug entered Phase 2 clinical trial
s.
of the drug. The researchers said the results demonstrated "potent, rapid, prolonged, dose-dependent, highly significant antiviral activity" for PRO 140. Participants in the highest dosing group received 5 mg/kg and showed an average viral load decrease of -1.83 log10
. On average, reductions of greater than -1 log10
copies/ml were maintained for between two and three weeks, from only a single dose of the drug. The largest individual HIV RNA reductions ranged up to -2.5 log10 among patients receiving both the 2 and 5 mg/kg doses.
Humanized antibody
Humanized antibodies are antibodies from non-human species whose protein sequences have been modified to increase their similarity to antibody variants produced naturally in humans. The process of "humanization" is usually applied to monoclonal antibodies developed for administration to humans...
monoclonal antibody targeted against the CCR5
CCR5
C-C chemokine receptor type 5, also known as CCR5, is a protein that in humans is encoded by the CCR5 gene. CCR5 is a member of the beta chemokine receptors family of integral membrane proteins...
receptor found on T lymphocytes of the human immune system
Immune system
An immune system is a system of biological structures and processes within an organism that protects against disease by identifying and killing pathogens and tumor cells. It detects a wide variety of agents, from viruses to parasitic worms, and needs to distinguish them from the organism's own...
. It is being investigated as a potential therapy in the treatment of HIV infection.
The United States Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
has designated PRO 140 for fast-track approval
FDA Fast Track Development Program
The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration that accelerates the approval of investigational new drugs undergoing clinical trials with the goal review time of 60 days...
. In February 2008, the drug entered Phase 2 clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s.
Development
PRO 140 is being developed by Progenics Pharmaceuticals. In May 2007, they announced results from the phase I clinical trialClinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
of the drug. The researchers said the results demonstrated "potent, rapid, prolonged, dose-dependent, highly significant antiviral activity" for PRO 140. Participants in the highest dosing group received 5 mg/kg and showed an average viral load decrease of -1.83 log10
Common logarithm
The common logarithm is the logarithm with base 10. It is also known as the decadic logarithm, named after its base. It is indicated by log10, or sometimes Log with a capital L...
. On average, reductions of greater than -1 log10
Common logarithm
The common logarithm is the logarithm with base 10. It is also known as the decadic logarithm, named after its base. It is indicated by log10, or sometimes Log with a capital L...
copies/ml were maintained for between two and three weeks, from only a single dose of the drug. The largest individual HIV RNA reductions ranged up to -2.5 log10 among patients receiving both the 2 and 5 mg/kg doses.