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news.Human Genome Sciences has received clearance from the FDA of its investigational new drug application to begin clinical trials of CCR5 mAb for the treatment of HIV/AIDS.
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CCR5 mAb (CCR5mAb004) is a fully human monoclonal antibody that specifically recognizes and binds the chemokine receptor CCR5. The CCR5 receptor is known to be a key facilitator of infection with HIV-1, the retrovirus that causes AIDS.
Human Genome Sciences now plans to proceed with a phase I clinical trial to evaluate the safety, tolerability and pharmacology of CCR5 mAb in patients who are infected with HIV-1. The phase I trial will be a randomized, placebo-controlled, dose-escalation, multi-center study.
The primary objective of the study will be to evaluate the safety and tolerability of escalating doses of a single intravenous (IV) infusion of CCR5 mAb. The secondary objectives of the phase I study will be to determine the pharmacokinetics of CCR5 mAb, and to assess its effect on plasma HIV-1 viral load and on CD4+ and CD8+ T-cell counts over time.
The CCR5 receptor is a co-receptor on the cell surface that, together with CD4, mediates the binding of HIV-1 and its entry into the cell. Research has shown that the CCR5 receptor is the primary co-receptor for enabling HIV-1 transmission and replication from the early stages of disease through progression to AIDS.
Research also has demonstrated that people who lack a functional CCR5 receptor are resistant to HIV infection or have slower HIV/AIDS disease progression, and that blocking the biological function of CCR5 with antagonists or chemokines can inhibit HIV replication.
Pre-clinical studies of CCR5 mAb show that it binds specifically and with high affinity to human CCR5, prevents HIV-1 entry, demonstrates no agonistic activity or effector functions, and has a prolonged serum half-life.
Dr David Stump, executive vice president of drug development, said, “I am pleased that we are now able to initiate a phase I clinical trial of CCR5 mAb for use in the treatment of patients who are infected with HIV-1. We believe that CCR5 mAb has the potential to provide a novel therapeutic option for the treatment of HIV infection and AIDS.”