A Phase 2 Study of the Safety and Effectiveness of SANGUINATE™ in the Treatment of Vaso-Occlusive Crises in the Ambulatory Setting: A Placebo-Controlled, Single-Dose, Single-Blind Study in Adults With Sickle Cell Disease

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis

开始日期2016-11-01

申办/合作机构

Prolong Pharmaceuticals LLC

NCT02672540 / Completed临床2期

A Phase II, Multicenter, Single-Blind, Randomized Study of the Safety and Effectiveness of SANGUINATE™ Versus Normal Saline in Adult Sickle Cell Disease Patients With Vaso-Occlusive Crisis (VOC)

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis who are admitted to the hospital for treatment.

开始日期2016-07-01

申办/合作机构

Prolong Pharmaceuticals LLC

NCT02754999 / Completed临床1期

An Open-label Phase 1 Safety Study of SANGUINATE™ Infusion in Patients With Acute Severe Anemia Who Are Unable to Receive Red Blood Cell Transfusion

In this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of the acute anemic episode.

开始日期2016-03-01

申办/合作机构

Prolong Pharmaceuticals LLC

100 项与 Pegylated bovine carboxyhemoglobin 相关的临床结果

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100 项与 Pegylated bovine carboxyhemoglobin 相关的转化医学

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100 项与 Pegylated bovine carboxyhemoglobin 相关的专利（医药）

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125

项与 Pegylated bovine carboxyhemoglobin 相关的文献（医药）

2024-07-01·Journal of Clinical Immunology

Treatment with Elapegademase Restores Immunity in Infants with Adenosine Deaminase Deficient Severe Combined Immunodeficiency

Article

作者: Bali, Pawan ; Mousallem, Talal ; Tarrant, Teresa K ; Hicks, Elizabeth Daly ; Buckley, Rebecca H ; Hall, Geoffrey ; Sleasman, John W ; Hershfield, Michael S

AbstractPurposePatients with adenosine deaminase 1 deficient severe combined immunodeficiency (ADA-SCID) are initially treated with enzyme replacement therapy (ERT) with polyethylene glycol-modified (PEGylated) ADA while awaiting definitive treatment with hematopoietic stem cell transplant (HSCT) or gene therapy. Beginning in 1990, ERT was performed with PEGylated bovine intestinal ADA (ADAGEN®). In 2019, a PEGylated recombinant bovine ADA (Revcovi®) replaced ADAGEN following studies in older patients previously treated with ADAGEN for many years. There are limited longitudinal data on ERT-naïve newborns treated with Revcovi.MethodsWe report our clinical experience with Revcovi as initial bridge therapy in three newly diagnosed infants with ADA-SCID, along with comprehensive biochemical and immunologic data.ResultsRevcovi was initiated at twice weekly dosing (0.2 mg/kg intramuscularly), and monitored by following plasma ADA activity and the concentration of total deoxyadenosine nucleotides (dAXP) in erythrocytes. All patients rapidly achieved a biochemically effective level of plasma ADA activity, and red cell dAXP were eliminated within 2–3 months. Two patients reconstituted B-cells and NK-cells within the first month of ERT, followed by naive T-cells one month later. The third patient reconstituted all lymphocyte subsets within the first month of ERT. One patient experienced declining lymphocyte counts with improvement following Revcovi dose escalation. Two patients developed early, self-resolving thrombocytosis, but no thromboembolic events occurred.ConclusionRevcovi was safe and effective as initial therapy to restore immune function in these newly diagnosed infants with ADA-SCID, however, time course and degree of reconstitution varied. Revcovi dose may need to be optimized based on immune reconstitution, clinical status, and biochemical data.

2024-06-01·Nanomedicine: Nanotechnology, Biology and Medicine

Riboflavin-targeted polymers improve tolerance of paclitaxel while maintaining therapeutic efficacy

Article

作者: Darguzyte, Milita ; Rama, Elena ; Rix, Anne ; Baier, Jasmin ; Rezvantalab, Sima ; Hermann, Juliane ; Kiessling, Fabian ; Jankowski, Joachim ; Khedri, Mohammad

Active targeting can enhance precision and efficacy of drug delivery systems (DDS) against cancers. Riboflavin (RF) is a promising ligand for active targeting due to its biocompatibility and high riboflavin-receptor expression in cancers. In this study, RF-targeted 4-arm polyethylene glycol (PEG) stars conjugated with Paclitaxel (PTX), named PEG PTX RF, were evaluated as a targeted DDS. In vitro, PEG PTX RF exhibited higher toxicity against tumor cells compared to the non-targeted counterpart (PEG PTX), while free PTX displayed the highest acute toxicity. In vivo, all treatments were similarly effective, but PEG PTX RF-treated tumors showed fewer proliferating cells, pointing to sustained therapy effects. Moreover, PTX-treated animals' body and liver weights were significantly reduced, whereas both remained stable in PEG PTX and PEG PTX RF-treated animals. Overall, our targeted and non-targeted DDS reduced PTX's adverse effects, with RF targeting promoted drug uptake in cancer cells for sustained therapeutic effect.

2024-04-01·Journal of Comparative Effectiveness Research

PEG hydrogel sealant versus fibrin glue in posterior fossa surgery: an economic comparison across five European countries

Article

作者: Horaczek, Jörn-Andre ; Talamonti, Giuseppe ; Torres, Rafael Torrejon ; Deppo, Lisa Da ; Carter, Marissa J

Aim: Posterior cranial fossa (PCF) surgery is associated with complications, including cerebrospinal fluid (CSF) leakage. Dural sealants such as polyethylene glycol (PEG)-based hydrogels and fibrin glue can prevent CSF leaks, with evidence suggesting PEG hydrogels may outperform fibrin glue. However, the budget impact of using PEG hydrogels in PCF surgeries in Europe is unclear. Materials & methods: A decision tree was developed based on a previous US model, to assess the budget impact of switching from fibrin glue to PEG hydrogel in PCF surgery across five European countries. Input costs were derived from published sources for the financial year 2022/2023. Health outcomes, including CSF leaks, were considered. Results: The model predicted that using PEG hydrogel instead of fibrin glue in PCF surgery can lead to cost savings in five European countries. Cost savings per patient ranged from EUR 419 to EUR 1279, depending on the country. Sensitivity analysis showed that the incidence of CSF leaks and pseudomeningoceles had a substantial impact on the model's results. Conclusion: PEG hydrogels may be a cost-effective alternative to fibrin glue in PCF surgery. The model predicted that cost savings would be mainly driven by a reduction in the incidence of postoperative CSF leaks, resulting in reduced reliance on lumbar drains, reparative surgery and shortened hospital stays.

项与 Pegylated bovine carboxyhemoglobin 相关的新闻（医药）

2024-11-13

·Business Wire

Prolong Pharmaceuticals to Present Clinical Data regarding PP-007, PEGylated carboxyhemoglobin bovine product, at the 2024 International Symposium on Blood Substitutes (ISBS)

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.

快速通道

2023-02-09

·BioSpace

Prolong Pharmaceuticals Announces Presentation of Phase 1 Data from HEMERA-1 Clinical Study of PP-007 in Patients with Acute Ischemic Stroke at the Late-Breaking Science Session, ISC 2023

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:

临床1期临床结果

100 项与 Pegylated bovine carboxyhemoglobin 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
移植物功能延迟恢复	临床3期	-	Prolong Pharmaceuticals LLC	-
移植物功能延迟恢复	临床3期	-	Enzon Pharmaceuticals, Inc.	-
下肢溃疡	临床2期	多米尼加共和国	Prolong Pharmaceuticals LLC	2016-03-01
下肢溃疡	临床2期	巴拿马	Prolong Pharmaceuticals LLC	2016-03-01
脑死亡	临床2期	美国	Prolong Pharmaceuticals LLC	2015-08-01
肾移植功能延迟	临床2期	美国	Prolong Pharmaceuticals LLC	2015-08-01
非浸润性导管内癌	临床2期	美国	Prolong Pharmaceuticals LLC	2014-12-01
蛛网膜下腔出血	临床2期	美国	Prolong Pharmaceuticals LLC	2014-12-01
镰状细胞血症	临床2期	-	Enzon Pharmaceuticals, Inc.	-
脑缺血	临床2期	-	Enzon Pharmaceuticals, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02411708 (ASH2017) 人工标引	临床2期	血管闭塞危机	-	PEG-COHb 320 mg/kg	(鏇壓繭壓獵廠積製餘壓) = 廠艱鏇繭醖壓鬱選膚鹽糧觸願鹹窪壓鑰衊選鬱 (膚簾鑰窪廠遞網壓遞糧 ) 更多	积极	2017-12-07
				placebo	(鏇壓繭壓獵廠積製餘壓) = 餘鏇範鑰鏇淵願獵齋艱糧觸願鹹窪壓鑰衊選鬱 (膚簾鑰窪廠遞網壓遞糧 )
ISC2017	N/A	蛛网膜下腔出血	12	Sanguinate 160mg/kg	獵獵選觸繭淵蓋積繭簾(遞鏇積鹽餘選窪襯積範) = 構襯憲膚淵繭襯簾衊鹽鹹選淵範襯觸積願繭齋 (網築範艱醖鹽築獵築觸 ) 更多	-	2017-02-01
				Sanguinate 240mg/kg	獵獵選觸繭淵蓋積繭簾(遞鏇積鹽餘選窪襯積範) = 繭襯窪壓廠壓餘製築鹹鹹選淵範襯觸積願繭齋 (網築範艱醖鹽築獵築觸 ) 更多
ISC2017	N/A	-	-	SanguinateTM	網鑰糧網獵鏇獵鹹願築(夢憲衊築憲簾餘積鏇廠) = 鹹廠廠積窪衊壓艱衊鹽鏇簾鑰壓願積憲鏇遞觸 (觸衊衊觸衊膚夢膚願鹹 )	-	2017-02-01
				Vehicle (Lactated Ringer’s)	網鑰糧網獵鏇獵鹹願築(夢憲衊築憲簾餘積鏇廠) = 積膚齋艱範願襯艱齋淵鏇簾鑰壓願積憲鏇遞觸 (觸衊衊觸衊膚夢膚願鹹 )
NCT01848925 (Pubmed) 人工标引	临床1期	镰状细胞血症	24	SANGUINATE	(鏇積醖餘鏇鹹觸艱糧壓) = Musculoskeletal related events were the most common. Transient troponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity 顧糧顧獵積夢蓋鬱醖齋 (鹹鹽獵簾積鬱膚遞壓網 )	积极	2017-01-01
ASCO2015	N/A	贫血	5	PEG-HbCO	選簾壓網鏇憲築顧鑰壓(餘顧淵衊餘壓願繭艱憲) = 鑰觸廠願願鏇艱願憲選願艱齋蓋醖壓繭選繭製 (淵鑰繭顧蓋簾艱鹹鏇鹹 )	积极	2015-05-20