Pegylated bovine carboxyhemoglobin

SOUTH PLAINFIELD, N.J.--( BUSINESS WIRE )--Prolong Pharmaceuticals, LLC (the Company), a clinical-stage biopharmaceutical company, announced that the Company will deliver two oral presentations, an oral abstract, and two posters at the International Symposium on Blood Substitutes ( ISBS ) held on November 14-18, 2024, in National Harbor, Maryland. Oral Presentations Presenter: Dr. Shaunak Pandya, Director, CMC R&D, Prolong Pharmaceuticals Session: Updates on Bio-Synthetic Blood Components Title: PEGylated Bovine Hemoglobin: Manufacturing and Characterization Date/Time: Friday, November 15, 2024, 7:30 PM–7:55 PM ET Presenter: Dr. Ronald Jubin, Vice President of R&D, Prolong Pharmaceuticals Session: Bio-Synthetic Blood Components in Active Human Trials Title: SANGUINATE® Clinical Trials Date/Time: Sunday, November 17, 2024, 2:35 PM–3:00 PM ET *Date/Times subject to change The Company will present its lead asset, PP-007 (PEGylated carboxyhemoglobin bovine, also known as SANGUINATE ® ), a novel clinical stage biopharmaceutical product that is universally compatible, thermally stable, and in a ready-to-administer intravenous formulation. PP-007 recently received Fast Track Designation in acute ischemic stroke and the Company is actively planning a pivotal approval trial. Hemorrhagic shock is considered the leading cause of death in trauma patients leading to 30-40% of deaths. Given ~50% of these deaths occur in the pre-hospital period due to blood loss, there is an urgent need for versatile treatments for a broad range of patients where blood transfusion is not an option (BNAO) or when blood is not readily available. BNAO patients treated in PP-007’s safety studies demonstrated survival benefits, warranting further investigation. “PP-007 has tremendous potential in improving blood flow and increasing survival in patients suffering from hemorrhagic/hypovolemic shock, ischemia/hypoxia, and severe anemia. Its diverse applications—including rapidly transferring oxygen, improving perfusion and organ function, and reducing inflammation—make it relevant across a breadth of indications, such as trauma, ischemic stroke, oncology, and more. Whether as a monotherapy or adjunct treatment, we are encouraged by the collective data supporting PP-007’s numerous mechanisms of action,” says Ronald Jubin, Ph.D. Vice President of R&D at Prolong Pharmaceuticals . In addition to numerous published non-clinical studies of ischemia/hypoxia and anemia, over 300 individuals in 12 completed clinical trials have received single or multi-dose PP-007 treatments including subarachnoid hemorrhage, life-threatening anemia, and other diseases/conditions with an underlying ischemia/hypoxia component, such as beta thalassemia and sickle cell disease. PP-007 is an investigational drug product and not approved for use in any country/indication. About Prolong Pharmaceuticals, LLC Prolong Pharmaceuticals is an advanced clinical stage pharmaceutical company that is vertically integrated with a proprietary state-of-the-art manufacturing facility headquartered in South Plainfield, New Jersey. Prolong Pharmaceuticals 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.

Novel Biotherapeutic Product Focused on The Treatment of Acute Ischemic Stroke SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)-- 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, and Principal Investigator of the study, 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 (NCT04677777). About PP-007 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: . View source version on businesswire.com: Contacts Ronald Jubin, Ph.D. Vice President, Early Development Prolong Pharmaceuticals Ph: (908) 315-5762 rjubin@prolongpharma.com Source: Prolong Pharmaceuticals View this news release online at: