Prolong Pharmaceuticals to Present Preliminary Phase 1 Data from HEMERA-1 for PP-007 in Acute Ischemic Stroke (AIS) at the 2025 International Stroke Conference (ISC)
SOUTH PLAINFIELD, N.J. --(BUSINESS WIRE)
Prolong Pharmaceuticals, LLC (the Company), a clinical-stage biopharmaceutical company, announced that it will present new clinical data from HEMERA-1 (Phase 1 clinical trial in AIS), at the International Stroke Conference (ISC) on February 5-7th, 2025, in Los Angeles, California.
The Company’s poster presentation will provide updates on their lead asset PP-007, a PEGylated carboxyhemoglobin bovine product, in AIS. Prolong recently completed enrollment for Part 3 of the Phase 1 trial, marking a key milestone for the program. The final Data Safety Monitoring Board (DSMB) review was also completed with no significant safety signals, further supporting the progression into Phase 3 development.
ISC Presentation | ||||
Presenter: | Dr. Italo Linfante, Medical Director of Interventional Neuroradiology at Miami Neuroscience Institute, Baptist Health South Florida, PI of HEMERA-1 | |||
Title: | HEMERA-1: CarboxyHEMoglobin OxygEn delivery for Revascularization in Acute Stroke: A Multi-Step clinical study of safety, efficacy and Pharmacokinetics | |||
Date/Time: | Wednesday, February 5th, 2025, 7:00 PM–7:30 PM PT | |||
Location: | Hall G | |||
"We are encouraged by the positive findings from the Phase 1 trial, particularly the successful completion of the final DSMB review, which reinforces PP-007’s safety profile,” says Dr. Italo Linfante, Principal Investigator of the HEMERA-1 trial, “The Prolong team is actively planning HEMERA-2 (global Phase 3 randomized clinical trial), which will be a critical step toward regulatory approval.”
About PP-007
PP-007 (PEGylated carboxyhemoglobin bovine—SANGUINATE®) is a novel biopharmaceutical product that is universally compatible, thermally stable, and in a ready-to-administer intravenous formulation. PP-007 has demonstrated improvement in blood flow, oxygen transfer, inflammation reduction, and supports perfusion and organ function. PP-007 received Fast Track Designation in AIS.
Numerous non-clinical studies have been published on ischemia/hypoxia and anemia, with ~300 individuals in 12 completed clinical trials having received single/multi-dose PP-007 treatments including subarachnoid hemorrhage, anemia, and other diseases/conditions with underlying ischemia/hypoxia, 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 state-of-the-art manufacturing facility headquartered in South Plainfield, N.J. Prolong Pharmaceuticals is developing PP-007 as an AIS treatment to lessen the debilitating comorbidities associated with reduced QoL, increased medical cost, and significant mortality.
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Ronald Jubin, Ph.D.
Vice President, R&D
Prolong Pharmaceuticals
[email protected]
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