Safety Study of PP-007 in Subjects With Acute Ischemic Stroke

NCT04677777 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PIS007-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief Summary

The HEMERA-1 Extension (Part III) is a prospective, open-label, multicenter study to evaluate safety of two doses of PP-007 in Acute Ischemic Stroke (AIS) subjects receiving Intravenous Thrombolysis (IVT) or mechanical thrombectomy (MT) or IVT+MT as standard of care (SOC). Subjects will receive two doses of PP-007 infusion 24 ± 6 hours apart in addition to the site-specific SOC protocol. PP-007 is PEGylated bovine carboxyhemoglobin and will be administered via IV infusion. The effects on collateral flow, infarct size and functional outcomes will be evaluated.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Thrombectomy; Intravenous Thrombolysis; NIHSS, mRS, ASPECTS

Outcome Measures

Primary Outcomes (16)

• Vital Signs

  Change from baseline in systolic and diastolic blood pressure in mm Hg

  90 days

• Heart-rate

  Change from baseline in heart-rate in bpm

  90 days

• 12-lead ECG

  Change from baseline in msec for QT, QTc, RR and PR intervals

  90 days

• Clinically significant change from baseline in Biochemical, hematological, coagulation and urinalysis measures

  Number of subjects with clinically significant change from baseline in Biochemical, hematological, coagulation and urinalysis measures

  90 days

• Cardiovascular Adverse Events (MI, myocardial injury, hypertension. hypertensive crisis, pulmonary hypertension) & Mortality

  Number of occurrences

  90 days

• Symptomatic intracranial hemorrhage

  Incidence of symptomatic intracranial hemorrhage, number of occurrences

  90 days

• Major Bleeding incidences

  Number of occurrences

  90 days

• Adverse Events

  Presence or absence

  90 days

• Bleeding requiring surgical intervention

  Number of occurrences

  90 days

• Bleeding requiring intravenous vasoactive drugs

  Number of occurrences

  90 days

• Intracranial hemorrhage

  Number of occurrences

  90 days

• Intraocular bleed compromising vision

  Number of occurrences

  90 days

• Fatal bleeding

  Number of occurrences

  90 days

• AESI, Blood pressure

  Number of events of systolic blood pressure \[SBP\] \>220 mmHg or diastolic blood pressure \[DBP\] \>120 mmHg

  90 days

• AESI, Liver panel

  Number of events of Liver enzymes elevation \>3.0 × Baseline or upper limit of normal \[ULN\]

  90 days

• AESI, neurological deterioration

  Number of occurrences of Neurological deterioration (≥4-point increase from Baseline in National Institutes of Health Stroke Scale (NIHSS).

  90 days

Secondary Outcomes (6)

• Clinical Activity, ASITN collateral score

  90 days

• Clinical Activity

  90 days

• Clinical Activity, NIHSS and mRS

  90 days

• Plasma Concentration of PP007

  24 hours

• Clinical Activity, eTICI

  90 days

Study Arms (1)

PP-007 along with Standard of care (SOC)

EXPERIMENTAL

The study has only single arm, wherein, patients will receive two doses of PP-007 (24 ± 6 hours apart), along with the Standard-of-care (SOC) as per the site's medical practice. SOC is defined as Intravenous thrombolysis (IVT) or Mechanical Thrombectomy (MT) or both (IVT+MT).

Biological: PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT)

Interventions

PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT) BIOLOGICAL

PP-007 is PEGylated carboxyhemoglobin. Eligible patients will receive two doses of PP-007 (at least 24 hours apart) to evaluate extended drug exposure along with MT and/or IVT (individually or together) as SOC to evaluate safety in AIS patients.

Also known as: Sanguinate

PP-007 along with Standard of care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject or subject's LAR has provided informed consent.
• ≥18 years of age.
• If the patient were to receive MT, patient must have a history of last seen well ≤ 24 hours prior to start of MT
• If the patient were to receive IVT, patient must have a history of last seen well ≤ 4.5 hours prior to start of IVT or as per Institution SOC Note: Onset is defined as the time point when symptoms first began, or if unknown, the last time point when the subject reported or was observed having normal (baseline) neurological function.
• AIS patient with ASPECTS ≥ 3 to 10
• AIS patient with life expectancy of 90 days, as determined by the investigator
• Patient with disabling stroke defined as baseline NIHSS ≥ 6 prior to IP administration
• mRS ≤ 2 (pre-morbid), prior to onset of symptoms (self-reported or family/caregiver reported)
• At the time of stroke, patient must be living in their own home, apartment or seniors lodge where no nursing care/support is required
• Subject and caregiver are available for protocol-required follow-up visits
• Contraception and pregnancy:
• Male subjects, and females of childbearing potential (subjects and female partners of male subjects who are ovulating, premenopausal, and not surgically sterile) must use a highly effective method of contraception consistently and correctly during study participation and up to 90 days following PP-007 infusion.
• Highly effective methods of contraception are those that, either alone or in combination, result in a failure rate of \<1% per year when used consistently and correctly, including:
• i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (i.e., oral, intravaginal, or transdermal).
• ii. Progesterone-only hormonal contraception associated with inhibition of ovulation (i.e., oral, injectable, or implantable).

You may not qualify if:

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• ASPECTS \< 3 on NCCT
• Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation)
• Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on initial CTA/CTP, or history of intracranial hemorrhage within the last 30 days.
• Pre-existing neurological or psychiatric disease that would confound neurological or functional evaluations in the opinion of the Investigator.
• A seizure at stroke onset that precludes obtaining an accurate screening NIHSS and mRS assessment
• Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic
• History of severe head injury within 90 days of Baseline with residual neurological deficit at the time of AIS.
• Clinically significant heart disease including:
• a. Symptoms or ECG evidence of acute myocardial infarction or unstable angina. b. Cardiac arrhythmia associated with hemodynamic instability. c. Heart failure (New York Heart Association Class III or IV) or known ejection fraction \<30%.
• d. ECG with second- or third-degree heart block in the absence of a permanent pacemaker.
• Refractory BP (systolic \>200 and/or diastolic \>120 mmHg).
• Confirmed diagnosis of septic embolus or bacterial endocarditis within the past six months.
• Aortic dissection.
• Contraindication to radiographic imaging procedures including:

Sponsors & Collaborators

• Prolong Pharmaceuticals: lead

Study Sites (8)

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

Baptist Health Miami Cardiac & Vascular Institute (MCVI)

Miami, Florida, 33176, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Stroke Center at Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

UPMC Stroke Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Linfante I, Clark W, Haussen DC, Hanel R, Reshi R, Dabus G, Jubin R, Roshan MP, Belnap S, Nguyen TN, Grotta J, Wicks R, Cipolla MJ, Liebeskind DS, Nogueira RG. HEMERA 1 CarboxyHEMoglobin oxygEn delivery for Revascularization in Acute Stroke: A Prospective, Randomized Phase 1 Clinical Trial. Stroke Vasc Interv Neurol. 2024 Apr 23;4(4):e001246. doi: 10.1161/SVIN.123.001246. eCollection 2024 Jul.

  PMID: 41585378 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

PEGylated carboxyhemoglobin bovine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kirsten Gruis, MD

  Prolong Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Contemporaneously controlled, open-label safety study

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 21, 2020
• Study Start: April 24, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (8)