SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, announced today that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS).

新泽西州南普莱恩菲尔德（商业新闻短讯）——临床阶段生物制药公司Prolong Pharmaceuticals，LLC今天宣布，其研究疗法PP-007（聚乙二醇化羧基血红蛋白，牛）已获得美国食品和药物管理局（FDA）的快速通道指定，用于治疗急性缺血性中风（AIS）。

PP-007 is currently being evaluated for safety and efficacy in an ongoing U.S.-based clinical trial, HEMERA-1..

PP-007目前正在美国进行的一项临床试验HEMERA-1中进行安全性和有效性评估。。

'Receiving Fast Track designation underscores the groundbreaking potential of PP-007, backed by years of research. We believe no other stroke drug in development offers this unique combination: (1) opening collateral vessels, (2) selectively delivering oxygen to hypoxic neurons, (3) reducing inflammation, and (4) sustaining effects for 24 hours, as shown in pharmacokinetic studies with acute stroke patients.

“获得快速通道称号突显了PP-007在多年研究支持下的开创性潜力。我们认为，没有其他正在开发的中风药物提供这种独特的组合：（1）开放侧支血管，（2）选择性地向缺氧神经元输送氧气，（3）减轻炎症，以及（4）维持24小时的作用，如急性卒中患者的药代动力学研究所示。

These capabilities, demonstrated in multiple PP-007 studies, are driving advances in stroke care and addressing critical unmet needs in acute ischemic stroke,' stated Ronald Jubin, Ph.D. Vice President of Early Development at Prolong Pharmaceuticals..

Prolong Pharmaceuticals负责早期开发的副总裁罗纳德·朱宾（RonaldJubin）博士表示，这些能力在多项PP-007研究中得到了证实，正在推动中风护理的进步，并解决急性缺血性中风的关键未满足需求。。

Each year, over 700,000 ischemic strokes occur in the United States alone, highlighting the critical need for new therapies to address unmet medical needs in stroke care. While advances such as intravenous thrombolytic agents—TNKase® (tenecteplase) and Activase® (alteplase)—and the mechanical thrombectomy (MT) procedure have improved outcomes, approximately 50% of patients still experience significant disabilities.

仅在美国，每年就有超过70万例缺血性中风发生，这突出表明迫切需要新的疗法来解决中风护理中未满足的医疗需求。虽然静脉溶栓剂TNKase®（替奈普酶）和活化酶®（阿替普酶）以及机械血栓切除术（MT）等进展改善了预后，但约50%的患者仍有严重残疾。

This percentage is even higher among those suffering from severe, large-volume strokes. “We are increasingly encouraged by the promising 90-day mRS outcome measures achieved with PP-007 treatment in combination with IVT and MT, particularly as we expand enrollment to include patients with ASPECT scores ranging from 3 to 5,” said Dr.

这一比例在那些患有严重、大量中风的人中甚至更高。“PP-007联合IVT和MT治疗取得了令人鼓舞的90天mRS结果指标，我们越来越受到鼓舞，特别是随着我们扩大登记范围，将ASPECT评分从3分到5分的患者包括在内，”Dr。

Italo Linfante, Principal Investigator of the HEMERA-1 study at Baptist Hospital in Miami, FL..

佛罗里达州迈阿密浸信会医院 HEMERA-1 研究的首席研究员 Italo Linfante。

“Recognizing annual World Stroke Day, we are excited to closely collaborate with the FDA to expedite the development of PP-007 to improve survival and quality-of-life outcomes in AIS patients,” said Dr. Kirsten Gruis, Chief Medical Officer of Prolong Pharmaceuticals.

Prolong Pharmaceuticals首席医疗官Kirsten Gruis博士说：“认识到每年的世界中风日，我们很高兴与FDA密切合作，加快PP-007的开发，以提高AIS患者的生存率和生活质量。”。

About the HEMERA-1 Study (carboxyHEMoglobin oxygEn delivery for Revascularization in Acute stroke)

关于HEMERA-1研究（碳氧血红蛋白氧输送用于急性卒中血运重建）

The HEMERA-1 study is a randomized, blinded, contemporaneously controlled study of the safety, tolerability, efficacy, and pharmacokinetics of PP-007 in acute ischemic stroke patients. The study is ongoing at multiple stroke centers across the United States. Outcome measures and key eligibility criteria are described on www.clinicaltrials.gov (NCT04677777)..

HEMERA-1研究是一项随机，盲法，同时对照研究PP-007在急性缺血性卒中患者中的安全性，耐受性，有效性和药代动力学。这项研究正在美国多个中风中心进行。结果测量和关键资格标准在www.clinicaltrials.gov（NCT04677777）上进行了描述。。

About PP-007

关于PP-007

PP-007 (PEGylated carboxyhemoglobin bovine, also known as SANGUINATE®) is a novel clinical stage biopharmaceutical product. In addition to numerous published non-clinical studies of ischemia/hypoxia and anemia, over 300 individuals in 12 clinical trials have received single or multiple dose treatments with PP-007 including 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.

PP-007（聚乙二醇化羧基血红蛋白牛，也称为SANGUINATE®）是一种新型的临床阶段生物制药产品。除了许多已发表的关于缺血/缺氧和贫血的非临床研究外，12项临床试验中的300多名患者接受了PP-007的单剂量或多剂量治疗，包括蛛网膜下腔出血，严重威胁生命的贫血以及其他具有潜在缺血/缺氧成分的疾病或病症，如β地中海贫血和镰状细胞病。

PP-007 is an investigational drug product and not approved for use in any country or indication..

PP-007是一种研究药品，未被批准在任何国家或适应症中使用。。

About Prolong Pharmaceuticals, LLC

关于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.

Prolong Pharmaceuticals是一家先进的临床阶段制药公司，与总部位于新泽西州南普兰菲尔德的专有最先进的生产设施垂直整合。Prolong Pharmaceuticals正在开发PP-007作为急性缺血性卒中的治疗方法，以减少与生活质量下降，医疗费用增加和死亡率显着相关的衰弱合并症。