Prolong Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), for the treatment of acute ischemic stroke (AIS). This designation aims to accelerate the development and review of PP-007, which is currently being assessed in the HEMERA-1 clinical trial.
Novel Approach to Stroke Treatment
PP-007 is designed with a unique combination of mechanisms to address the complexities of acute ischemic stroke. According to Ronald Jubin, Ph.D., Vice President of Early Development at Prolong Pharmaceuticals, PP-007 opens collateral vessels, selectively delivers oxygen to hypoxic neurons, reduces inflammation, and sustains these effects for 24 hours. These capabilities have been demonstrated in multiple studies, suggesting a potential advancement in stroke care.
Addressing Unmet Needs in Stroke Care
Each year, over 700,000 ischemic strokes occur in the United States, and despite advances in treatment, a significant portion of patients still experience disabilities. Intravenous thrombolytic agents like TNKase® (tenecteplase) and Activase® (alteplase), along with mechanical thrombectomy (MT), have improved outcomes, but approximately 50% of patients continue to face substantial disabilities, especially those with severe strokes. Dr. Italo Linfante, Principal Investigator of the HEMERA-1 study at Baptist Hospital in Miami, FL, noted the encouraging 90-day mRS outcome measures achieved with PP-007 in combination with IVT and MT, particularly in patients with ASPECT scores ranging from 3 to 5.
HEMERA-1 Study Details
The HEMERA-1 study (carboxyHEMoglobin oxygEn delivery for Revascularization in Acute stroke) is a randomized, blinded, contemporaneously controlled trial evaluating 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, with outcome measures and key eligibility criteria available on www.clinicaltrials.gov (NCT04677777).
About PP-007
PP-007 (PEGylated carboxyhemoglobin bovine, also known as SANGUINATE®) is a clinical-stage biopharmaceutical product. It has been studied in over 300 individuals across 12 clinical trials, including those with subarachnoid hemorrhage, severe anemia, and conditions with an underlying ischemia/hypoxia component, such as beta thalassemia and sickle cell disease. It is currently an investigational drug and not approved for use in any country or indication. Kirsten Gruis, Chief Medical Officer of Prolong Pharmaceuticals, expressed excitement about collaborating with the FDA to expedite the development of PP-007 to improve survival and quality-of-life outcomes in AIS patients, coinciding with World Stroke Day.
