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 5-7^th, 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.

"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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