- CytoDyn (OTCQB:CYDY) reports that the first several subjects have been treated in its Phase 3 study assessing PRO 140 as single-agent maintenance therapy in 300 CCR5-tropic HIV-1 patients who are clinically stable on standard-of-care highly active antiretroviral therapy (HAART).
- Participants will be shifted from HAART regimens to PRO 140 subcutaneous injections for 48 weeks. The primary endpoint is the proportion of patients who remain on PRO 140 monotherapy for 48 weeks without experiencing virologic failure.
- According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is December 2017. The estimated study completion date is March 2018.
- The PRO 140 antibody is a viral entry inhibitor that targets the CCR5 (C-C chemokine receptor type 5) co-receptor, a protein on the surface of white blood cells that acts as a receptor for chemokines, signaling proteins that induce chemotaxis (chemical-induced movement) in nearby cells. This is the process by which the immune system's T cells are attracted to specific targets. HIV uses CCR5 to enter and infect host cells.
- PRO 140 will compete against the only other CCR5 antagonist approved for the treatment of HIV infection, ViiV Healthcare's (NYSE:GSK)(NYSE:PFE)(OTCPK:SGIOY) Selzentry (maraviroc). PRO 140's value proposition compared to Selzentry (and HAART) is less toxicity, fewer side effects and once-weekly administration versus daily.