Clinical trials
HEMERA-2 Planned
Who it is for: adults with an acute ischemic stroke caused by a blocked large artery (A-LVO) who are receiving standard treatment.
Design: a randomized, controlled Phase 3 trial designed with FDA input: standard of care alone against standard of care plus two PP-007 infusions about 24 hours apart, randomized 1:1.
For clinicians and sites
HEMERA-2 sites are thrombectomy-capable stroke centers. If your center may want to take part, get in touch and we will send the protocol summary.
HEMERA-1, completed
A three-part Phase 1/2 study at US stroke centers, 2021–2025. PP-007 was given alongside clot removal and/or clot-dissolving drugs.
No symptomatic brain bleeds were seen in any of the 47 treated patients, and the study's safety board attributed none of the deaths to PP-007.
Recovery is scored on the modified Rankin Scale (mRS), from 0, no symptoms, to 6, death. A score of 0–2 at 90 days is the goal, indicating functional independence.
- Registry
- NCT04677777
- Phase
- 1/2
- Years
- 2021–2025
- Treated
- 47 patients
- Where
- US stroke centers
Living independently at 90 days
mRS 0–2 · 40 A-LVO patients
Expected with standard of care~46.7%
HEMERA-1, with PP-00767.5%
Earlier studies
12 studies
- ACTRN12612001033831Healthy volunteers, three rising doses2012–13 · 24 enrolledPhase 1
- NCT01847222Healthy volunteers, rising doses2013–14 · 2 enrolled · stopped earlyPhase 1
- NCT01848925Sickle cell disease, compared with hydroxyurea2013–14 · 24 enrolledPhase 1
- NCT02323685Delayed cerebral ischemia after subarachnoid hemorrhage2014–16 · 12 enrolledPhase 2
- NCT02437422End-stage kidney disease2015 · 5 enrolledPhase 1
- NCT02490202Kidney transplant, delayed graft function2015–16 · 60 enrolledPhase 2/3
- NCT02600390Leg ulcers in sickle cell disease2016 · 10 enrolledPhase 2
- NCT02754999Severe anemia when transfusion is not an option2016–17 · 103 enrolledPhase 1
- NCT02672540Sickle cell crisis, inpatient2016–17 · 34 enrolledPhase 2
- NCT02411708Sickle cell crisis, outpatient2016–17 · 24 enrolledPhase 2
- ThailandThalassemia48 enrolledPhase 2
- ThailandThalassemia with pulmonary hypertension16 enrolledPhase 1