Fast Track Designation paves the way for Prolong Pharmaceuticals to pursue a pivotal trial for acute ischemic stroke
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). PP-007 is currently being evaluated for safety and efficacy in an ongoing U.S.-based clinical trial, HEMERA-1.
“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,” stated Ronald Jubin, Ph.D. Vice President of Early Development at Prolong Pharmaceuticals.
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. 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. Italo Linfante, Principal Investigator of the HEMERA-1 study at Baptist Hospital in Miami, FL.
“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.
About the HEMERA-1 Study (carboxyHEMoglobin oxygEn delivery for Revascularization in Acute stroke)
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).
About 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 is an investigational drug product and not approved for use in any country or 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. For more information visit: www.prolongpharma.com.
Contacts
Ronald Jubin, Ph.D.
Vice President, Early Development
Prolong Pharmaceuticals
300 Corporate Court, Suite B
South Plainfield, NJ 07080 USA
Ph: (908) 315-5762
rjubin@prolongpharma.com
