Table 2.

Rintatolimod open-label studies.

Protocol	No. of patients treated	Percent female	Observed safety and apparent efficacy
AMP 501 Phase I	14	75	Drug was well tolerated throughout study (majority >24 weeks) in a relatively homogenous CFS/ME cohort. Efficacy observed in exercise performance, neurocognition, and anti-HHV-6 activity [41].
AMP 502E Phase I/ II	22	73	Open-label extension study in a 22 patient cohort who completed double-blind AMP 502 treated during an open-label extension phase for 1 year or longer. Drug was well tolerated throughout study (Phase 1 extention of administration time. Extention (Phase II) provided major improvements in Karnoksky Performance Status (p < 0.0001) [43].
AMP 509 Phase II	45	70	Belgian open-label study, with 44 patients evaluated. Similar dosing procedure and endpoints as AMP 502 [42]
AMP 511 Phase II/III	139	65	Ongoing cost-recovery, open-label study of Safety and Efficacy with similar dosing procedures and endpoints as AMP 502 [42]
AMP 516E Phase III	190	73	Partially blinded cross-over cohort extension of double-blind AMP 516 study [44]
Total	412	70