Novel Biotherapeutic Product Focused on The Treatment of Acute Ischemic Stroke
Prolong Pharmaceuticals, a clinical stage biopharmaceutical company, today announced that preliminary data from the recently completed Phase 1 clinical study of PP-007 (HEMERA-1) in acute ischemic stroke (AIS) patients will be presented in the Late-Breaking Science session during ISC 2023 in Dallas, TX and in the forthcoming PAIRS conference in Dubai.
PP-007 (PEGylated carboxyhemoglobin, bovine) is a novel investigational biopharmaceutical product that improves microvascular perfusion while promoting transfer of oxygen to oxygen-deprived (hypoxic) cells and tissues. PP-007 has been shown in several non-clinical stroke models to improve collateral circulation, specifically delivering oxygen to hypoxic regions of the brain following a large vessel occlusion reducing neuronal death and improving neurological outcomes. HEMERA-1 is the first clinical trial of PP-007 in AIS.
Dr. Italo Linfante, Medical Director of Interventional Neuroradiology at Miami Neuroscience Institute, Baptist Health South Florida, Principal Investigator of the study, and distinguished member of Miami Scientific Italian Community stated, “The evaluation of PP-007 in AIS large vessel occlusion patients receiving a mechanical thrombectomy exhibited acceptable safety and tolerability. PP-007’s multi-modal mechanism of action includes (1) increased blood flow and vasodilation of collateral circulation, (2) targeted delivery of oxygen in ischemic areas for 24 hours, and (3) plasma expansion. This unique molecule has the potential to improve neurological scores and outcomes in AIS patients, and this foundational safety study warrants the expanded clinical evaluation of PP-007 in AIS.”
The following are the details of the presentations:
- ISC, Dallas, TX: Session A21; Late-Breaking Science Oral Abstracts; Title: Hemera 1 Carboxyhemoglobin Oxygen Delivery for Revascularization in Acute Stroke: Phase 1 clinical Trial–Thursday, February 9, 2:00-3:00 PM; Room C155/C156; Presenter: Dr. Italo Linfante, USA
- PAIRS, Dubai, UAE: Session 5; Title: Hemera 1 Carboxyhemoglobin Oxygen Delivery for Revascularization in Acute Stroke: Phase 1 clinical Trial; Sunday, February 12, 15:00-16:00 Hrs, Hall C; Presenter: Dr. Italo Linfante, USA
Prolong Corporate Statement
“This study represents a key milestone in the clinical development of PP-007 that builds upon our strong preclinical and clinical evidence for treating conditions of ischemia/hypoxia. We are extremely grateful to the study participants and the clinical research teams leading this important trial through such a challenging time with ongoing COVID-19,” stated Ronald Jubin, Ph.D., Vice President of Early Development at Prolong.
About the HEMERA-1 Study (carboxyHEMoglobin oxygEn delivery for Revascularization in Acute stroke)
The HEMERA-1 study is a randomized, Phase 1, blinded, contemporaneously controlled, single dose study of the safety, tolerability, and pharmacokinetics of PP-007 in acute ischemic stroke patients. The study is ongoing at multiple Stroke Centers in the United States. Outcomes measures and key eligibility criteria are described on www.clinicaltrials.gov (NCT04677777).
PP-007 (previously known as SANGUINATE®) is a clinical stage biopharmaceutical product. In addition to numerous published non-clinical studies of ischemia/hypoxia and anemia, over 270 individuals in 12 clinical trials have received single or multiple dose treatments in prior studies of PP-007 including healthy volunteers, subarachnoid hemorrhage, severe life-threatening anemia and other diseases or conditions with an underlying ischemia/hypoxia component, such as beta thalassemia and sickle cell disease.
About Prolong Pharmaceuticals
Headquartered in South Plainfield, New Jersey, Prolong Pharmaceuticals, LLC is developing PP-007 as a treatment for acute ischemic stroke to lessen the debilitating comorbidities associated with reduced quality of life, increased medical cost and significant mortality. For more information visit: www.prolongpharma.com.