CytoDyn (OTCQB:CYDY) announces that 34 patients have been enrolled in its Phase 2b/3 clinical trial assessing PRO 140, combined with antiretroviral therapy, in HIV-infected patients. 33 have completed the one-week efficacy endpoint and 11 have completed the full 25-week protocol with undetectable viral loads and 10 of these are currently in the rollover study.
• Target enrollment is 300. Dosing began in Q4 2016.
• The company says it will meet with the FDA on October 17 to discuss next steps "towards the analysis of the primary efficacy endpoint." The primary endpoint is already established (proportion of patients who remain on PRO 140 monotherapy at the end of week 48 without experiencing virologic failure) so it is unclear why a meeting with the FDA is necessary unless it wants to adjust the endpoint.
• 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 is less toxicity, fewer side effects and once-weekly administration versus daily.
