Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, has announced 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).
PP-007 is currently being evaluated for safety and efficacy in an ongoing U.S.-based clinical trial, HEMERA-1.
Ronald Jubin, Ph.D is Vice President of Early Development at Prolong Pharmaceuticals.
He said: “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.
“These capabilities, demonstrated in multiple PP-007 studies, are driving advances in stroke care and addressing critical unmet needs in acute ischemic stroke.”
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 and the mechanical thrombectomy (MT) procedure have improved outcomes, approximately 50 per cent of patients still experience significant disabilities.
This percentage is even higher among those suffering from severe, large-volume strokes.
Dr. Italo Linfante is Principal Investigator of the HEMERA-1 study at Baptist Hospital in Miami, FL.
Linfante said: “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 enrolment to include patients with ASPECT scores ranging from 3 to 5.”
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 centres across the United States.
